How You'll Make An Impact

Join us as an Enterprise Architect on our Global Technical Advisory Services team in North America to do the best work of your career and make a profound social impact.  As a Boomi Enterprise Architect, you will be responsible for strategically planning the enablement of digital capabilities  and aligning business-driven technologies to deliver business outcomes.

What You'll Do

• Lead the creation and evolution of the architecture program/function with focus on Customer digital transformation services.

• Demonstrate the business value of Architecture Services as an enabler of strategy formulation, and as support for innovation influencing technology decisions, which drives the Customer’s top and bottom lines.

• Lead, advise and guide on technology experiments for Customers, helping to create new products and services and integrating the best of theses into steady-state operations for the Customer.

• Assess current Customers IT environments and deficiencies, and recommend the strategic future-state of digital capabilities that will enable customers to continuously move their business forward with Boomi

• Develop and deliver actionable architecture artifacts to guide and support Customers digital technology decisions in full alignment with the execution of their business strategy

• Take the first step towards your dream career with Boomi

The Experience You Bring

• Master's or Bachelor's degree in business, computer science, computer engineering, electrical engineering, system analysis or a related field of study, or equivalent experience

• Ten or more years of experience in at least four disciplines, such as business, information, solution or technical architecture, application development, middleware, information analysis, database management or operations in a multitier environment

• Ten or more years of business experience in strategic and operations planning and/or business analysis

Bonus Points If You Have

• Knowledge of business models, operating models, financial models, cost-benefit analysis, budgeting and risk management

• Familiarity with information management practices, system development life cycle management, DevOps methodologies, infrastructure and operations, and EA (TOGAF and Zachman) and ITIL frameworks

• Knowledge of business ecosystems, SaaS, infrastructure as a service (IaaS), platform as a service (PaaS), SOA, APIs, open data, microservices, event-driven IT and predictive analytics

• Exposure and understanding of existing, new and emerging technologies, and processing environments

• Exceptional soft and interpersonal skills, strong teamwork and collaboration skills, facilitation and negotiation

• Strong leadership skills

Aren’t sure if you’re a match? We know that impostor syndrome and the confidence gap can prevent us from meeting spectacular candidates — so don’t hesitate to apply; you could be the perfect fit!

Compensation and Benefits

Boomi is committed to fair and equitable compensation practices. The On Target Earnings (OTE) for this role are 80% base and 20% commission.

Total Compensation begins at $175,000 and is determined by various factors including geographic location and the candidate's knowledge, skills, and experience. An overview of our benefits can be found here.

GenScript is a global leader in life sciences research tools and services, providing innovative solutions in gene synthesis, protein expression, antibody development, and cutting-edge mRNA/LNP technologies. Our mRNA & LNP Services team delivers end-to-end solutions for vaccine and therapeutic development — from sequence design and IVT mRNA synthesis to LNP formulation, analytics, and QC release testing.

We are seeking a detail-oriented and technically skilled QC Technician to join our rapidly growing mRNA & LNP Service Team. In this role, you will perform analytical testing and quality control assays to ensure the integrity, purity, potency, and consistency of mRNA products and lipid nanoparticle formulations. You will work closely with R&D, Manufacturing team, QA and Project management teams  to support client projects and internal process improvements .

Responsibilities:

• Responsible for supporting communication with production manager and team, contributing to a working environment that encourages employee involvement and collaboration.
• Conduct analytical assays including but not limited to:
• RNA concentration and purity (UV spectrophotometry, fluorometry)
• RNA integrity (Agilent Bioanalyzer, gel electrophoresis)
• dsRNA contamination (ELISA, immunoblot, HPLC)
• LNP particle size and polydispersity (DLS, others)
• Encapsulation efficiency (ribogreen assay, dye exclusion)
• Endotoxin testing
• pH, osmolality, sterility (as applicable)
• Reports out-of-specification results and deviations to the manager. Assists with investigations, root cause analysis, and reports for out-of-specification results and deviations.
• Responsible for timely completion of QC report after production job is finished. Accountable for the QC report compliance with good documentation practices.
• Support process improvement initiatives within scope of responsibility.
• Monitors supply inventory and identifies any products required.
• Maintains work area, equipment, department and all storage areas in a clean, neat and orderly manner.
• Perform other duties as needed.

Requirements:

• Bachelor's degree in molecular biology, chemistry, biochemistry, pharmaceutical science or related field, master’s is preferred.
• Experience with HPLC, LC-MS, ELISA, cell culture, and flow cytometry is preferred.
• Ability to communicate efficiently verbally and in writing.
• Ability to perform in a fast-paced environment with high product throughput.
• Ability to follow detailed instructions, maintain accurate records and notes, and carry out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices.

A sense of humility and an eagerness to continue to learn and contribute to a supportive team.

Benefit:

• Medical Insurance/ Vision Insurance/ Dental Insurance
• 401(k) & Retirement Savings Plan (RSP)
• Short Term Disability Insurance
• New Child Leave
• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Compassionate Leave
• Jury Duty Leave
• Float day
• Personal days

Perks: 

• Free colleague meals during shift
• Onsite massages Charis
• Onsite gyms

Compensation:
Salary range: $55,000 – $65,000 total compensation, including bonus, depending on experience and qualifications.

About this Role

Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities toward clinical production. This role will be responsible for all CMC activities across the external drug development pipeline of Varda’s partners. Reporting to the VP, Pharma Program Management), this position requires collaboration across multiple departments and external partners to design, develop, and implement novel approaches to manufacture drug products in low Earth orbit. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda’s product culture and will play a significant role in establishing the low Earth orbit economy. The ideal candidate must create and lead the CMC development team for drug products from early stage through clinical manufacturing.

Responsibilities

• Develop and lead all GMP CMC-related activities (biologics and small molecule) including process chemistry, drug product, analytical, and formulation from lead optimization phase through to clinical development and commercialization  
• Build and lead internal GMP CMC team with functions around process development, quality control, and quality assurance. 
• Manage external drug product manufacturing service providers and API supply chains to support clinical trial development  
• Collaborate with Varda pharma R&D teams to understand future CMC needs and handle internal tech transfers 
• Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials 
• Act as subject matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs 
• Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA 
• Monitor progress and regularly report to the C-suite team 
• Manage and monitor the CMC timelines and budget 

Basic Qualifications

• 8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• B.S. or M.S. in life sciences such as Chemistry, Biochemistry, or related fields 
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC 

Preferred Skills and Experience

• 12+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• PhD in life sciences such as Chemistry, Biochemistry, or related fields 
• Documented evidence of prior successful CMC project leadership from early phase, late phase leading to clinical trials. 
• Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing 
• Advanced understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas 
• Command of global CMC-related regulatory requirements and guidelines 
• Excellent leadership, managerial and communications skills in a cross functional environment 
• Hands-on experience in managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug product development) 
• Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU 
• Fluent communication in English, written and verbal 

Pay Range

• Salary range: $200,000 - $230,000/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for incentives in the form of stock options and/or long-term cash awards

As a Food Service Assistant at Bezos Academy, you’ll help provide nutritious, compliant meals to children at our tuition-free, Montessori-inspired preschool and provide direct support with a variety of additional tasks both in and out of the classroom. You will manage all aspects of food preparation and service with strong attention to detail, organization, and adherence to safety protocols. Key responsibilities include preparing CACFP-compliant menus, placing food orders and managing food costs, receiving and verifying food deliveries, ensuring all meals are delivered to classrooms on time, and managing all clean-up, organization, and documentation. Assuming full ownership of the kitchen and food operations at the school, you will serve meals in accordance with USDA requirements, Bezos Academy policies, and local childcare regulations.

Beyond the kitchen, you will assist school staff and administration with a variety of tasks including inventory checks, laundry, and other ad hoc duties. As needed, you will also occasionally step into classrooms to provide direct supervision and support to the children. You will become an integral part of your school team working to improve processes and provide an excellent preschool experience where we nurture every child’s full potential. 

LOCATION

We are actively hiring part-time Food Service Assistants at our Mesa, Arizona preschools with an expected start date of August 2026: 

• Mesa – Adobe Hills (1001 N Power Road, Mesa, AZ 85205)

SCHEDULE, BENEFITS, & COMPENSATION

• This is a part-time, non-exempt/hourly position requiring a minimum of 25 hours per week, with occasional opportunities to work additional hours based on school needs.  
• You will work a five-hour shift, Monday through Friday, totaling 25 hours per week. Specific school schedules are determined by school leaders when considering all staff, classroom, and community needs, but are currently expected to be 7:30am-12:30pm. 
• Compensation for this position is $19-$28 per hour. The upper third of the compensation range is typically reserved for existing employees who have been in the role for multiple years and who demonstrate strong performance over time. Starting compensation will vary by qualifications and prior experience. 
• Benefits include paid sick (care) time, accrued based on hours worked, and a 401(k) plan with a 4% employer contribution match.  

MINIMUM QUALIFICATIONS  

• Age 18 with high school diploma or GED  
• Ability to pass background checks and complete all trainings required by the Arizona Department of Children, Youth, and Families upon hire
• Knowledge of cooking methods and procedures, including various types of preparation
• Ability to lift up to 50 pounds, stand for long periods of time, and perform a variety of repetitive tasks to prepare and serve food safely
• Experience working in an institutional or highly regulated kitchen/food setting with a clear understanding of food preparation best practices and protocols
• Active and current food worker card
• Understanding of Arizona food and beverage worker manual
• Ability to speak, read, and write English fluently
• Basic proficiency in Microsoft Office (Word, Excel, Outlook)

PREFERRED QUALIFICATIONS  

• Experience working within the guidelines of the US Department of Agriculture and Child and Adult Care Food Program (USDA/CACFP)
• Two or more years of experience working in a school (preschool, early childhood education, daycare, or K-12 environment) or similar kitchen setting
• Working knowledge of food allergens, intolerances, preferences, and accommodations
• Prior experience as an Assistant Teacher in a preschool setting
• Associate’s degree in Early Childhood Education or two years of post-secondary coursework in Early Childhood Education
• Experience with Montessori pedagogy
• Experience with children with special needs
• Fluent in Spanish

RESPONSIBILITIES

NOTE: The combination of responsibilities may vary based on the needs of the school site, students, and prior experiences of the Food Service Assistant.

Food Service and Site Operations

• Place weekly food orders with the vendor based on student attendance trends and food waste analysis
• Receive and verify daily food deliveries to ensure accuracy with order quantities and alignment with the approved menu. If meals are non-compliant, follow the Emergency Food SOP
• Manage all aspects of routine vendor performance to ensure the vendor is meeting or exceeding expectations
• Ensure all meals served to students are compliant and document any menu changes on menu
• Track food consumption and waste daily to ensure food costs remain as lean and efficient as possible
• Prepare and serve meals and utensils to classrooms for each scheduled meal service
• Maintain compliance with strict food hygiene and safety protocols at all times and maintain compliance with all state and local jurisdictional requirements
• Ensure the kitchen, equipment, serving utensils, cookware, and dishes are consistently cleaned, sanitized, and well-maintained
• Manage and organize food inventory, including proper labeling, dating, rotating stock, and discarding items nearing expiration in accordance with food safety guidelines
• Record and log food temperatures prior to each meal service to ensure compliance with safety regulations
• Accommodate children’s special dietary needs, including allergies, medical restrictions, and cultural or religious food requirements
• Assist in serving meals during family engagement and school events as needed

Added responsibilities if food is prepared on-site:

• Place weekly groceries orders based on the menu and current inventory
• Receive and verify food delivery and follow up with vendor if food delivered is incorrect based on the order or spoiled
• Prepare meals according to the planned menu and adapt recipes for dietary restrictions (allergies, religious diets, vegetarian, etc.)
• Prepare meals on a schedule (breakfast/lunch/snack)
• Adapt the menu (make substitutions) to avoid food spoilage and waste following the Menu Substitution SOP
• Help plan menus that are nutritious, budget-friendly, and appealing to students

Added responsibilities if school is under CACFP:

• Ensure vendor provides a delivery receipt and keep it for 3 years
• Children receive the appropriate portion sizes for each meal pattern component by providing correctly sized serving utensils and clearly communicating the required serving sizes to classroom staff upon meal delivery
• Review meal counts for accuracy and upload into SharePoint weekly
• If there are any menu substitutions, provide the necessary menu-supporting documentation (CN label, product formulation statement, Nutrition Facts, standardized recipe)
• Attend the required annual sponsor CACFP training that includes meal pattern, reimbursement, meal counts, claims, recordkeeping, and civil rights
• Clock in/out of Workday based on food-related responsibilities

Classroom Support

• Provide classroom coverage as needed
• Assist teachers with the full implementation of Bezos Academy’s performance standards, policies, and procedures
• Support Bezos Academy classrooms by following regulations and guidelines in the day-to-day operation of the classroom (i.e., cleaning materials, meal prep, nap time transitions, etc.)
• Organize materials and clean the workspace to facilitate the learning process for each child
• Support children’s increasing independence with daily living skills (i.e., washing hands, using the bathroom, eating meals and snacks, cleaning up, etc.)
• Provide 1:1 support for children who are experiencing big feelings
• Develop positive relationships with children

Other

• Assist the Head of School and school staff in other operational duties in the school as necessary when the kitchen work is complete (e.g., support with laundry, front desk support, and other duties as assigned by the Head of School)
• Participate in team meetings, center activities, and staff development

Bezos Academy participates in E-Verify and will provide the federal government with employee Form I-9 Information to confirm authorization to work in the U.S. Bezos Academy only uses E-Verify once a candidate has accepted a job offer and completed the Form I-9. If E-Verify cannot confirm that an employee is authorized to work, Bezos Academy will give the employee written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) so the employee can begin to resolve the issue before any adverse employment action is taken. For more information about your right to work, please see the Notice of Right to Work.

Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

#LI-HYBRID #NC1

Data at Brex

Our Scientists and Engineers work together to make data — and insights derived from data — a core asset across Brex. But it's more than just crunching numbers. The Data team at Brex develops infrastructure, statistical models, and products using data. Our work is ingrained in Brex's decision-making process, the efficiency of our operations, our risk management policies, and the unparalleled experience we provide our customers.

What You’ll Do

As a Data Engineer at Brex, you will be a core contributor in transforming raw data into actionable insights for various departments across the organization. You'll collaborate closely with Data Scientists, Software Engineers, and business units to create efficient data models, pipelines, and analytics frameworks that drive the business forward. You also play a leading role in the design, implementation, and maintenance of Core Data tables, our high-quality, curated data source for a wide range of analytic applications. 

Where you’ll work

This role will be based in our San Francisco office. We are a hybrid environment that combines the energy and connections of being in the office with the benefits and flexibility of working from home. We currently require a minimum of three coordinated days in the office per week, Monday, Wednesday and Thursday. As a perk, we also have up to four weeks per year of fully remote work!

Responsibilities:

• Design, build, and maintain data models and pipelines that scale with the growing number of services, products, and changes in the company.
• Collaborate closely with Data Scientists, Data Analysts, and Business teams to understand their data needs, translating them into robust, efficient, scalable data solutions that enable ease of predictive analytics, data analysis, and metrics formulation. 
• Maintain data documentation and definitions, building and ensuring that source-of-truth tables remain high quality for data science and reporting applications. 
• Develop and enable integration with various data sources, allowing for more data-driven initiatives across the company.
• Apply best practices in data management to ensure the reliability and robustness of data utilized across various analytics applications.
• Set and proliferate company-wide standards for data relating to structure, quality, and expectations.
• Act as a liaison between the technical and non-technical teams, bridging gaps and ensuring that data solutions align with business objectives.
• Use agentic AI where it speeds up pipeline and quality work, without skipping validation.

Requirements:

• 3+ years of experience in Data Engineering, Data Analytics, or a related field such as Analytics Engineering.
• Advanced knowledge of databases and SQL with the ability to efficiently stage, process, and transform data.
• Experience integrating and orchestrating data workflows with various modern data tools and systems.
• Experience with data modeling, ETL/ELT processes, and data warehousing solutions.
• Experience working with a data warehouse such as Snowflake.
• Experience with a data workflow orchestrator tool such as Airflow.
• Experience with a programming language such as Python. 
• Experience with agentic AI. 
• Exceptional quantitative and analytical skills.
• Strong communication skills and ability to collaborate with various stakeholders, both technical and non-technical.

Nice to have:

• Familiarity with BI tools such as Looker, Tableau, or similar platforms. 
• Solid dbt in production: models, tests, docs, and collaboration in a shared repo. 
• AI-ready data: Metrics and dimensions are clear and reusable so AI-assisted analysis does not fork definitions. 
• Experience with Salesforce data integration. 

Compensation:

The expected salary range for this role is $120,800 - $151,000. However, the starting base pay will depend on a number of factors including the candidate’s location, skills, experience, market demands, and internal pay parity. Depending on the position offered, equity and other forms of compensation may be provided as part of a total compensation package.

Brex LLC is a wholly owned subsidiary of Capital One, N.A.

Manager, Corporate Development & Finance 

Sony Interactive Entertainment’s Corporate Development & Finance team helps define the long-term direction of PlayStation in a rapidly evolving global gaming and entertainment landscape. The team is responsible for Market Intelligence, Strategic Analysis, Investor Relations, and selected inorganic growth initiatives. We work closely with senior executives, business unit leaders, and functional partners across the company to develop rigorous analyses and actionable insights that guide critical decisions.

This role sits at the intersection of strategy formulation, market and competitive intelligence, and business case development. It is designed for a manager who wants to shape PlayStation’s long-term direction, influence executive decision-making, and operate across both strategic planning and selective inorganic growth. It offers broad exposure, high analytical ownership, and the opportunity to work on some of the most consequential questions facing the interactive entertainment industry.

What You’ll Be Doing:

Market Intelligence, Analysis, Modeling, and Insights

• Develop data-driven perspectives on mid-to-long-term trends in interactive entertainment, media, and technology

• Build financial, operating, and scenario models to support strategic decision-making

• Conduct quantitative and qualitative analyses leveraging internal data, external research, and market intelligence

• Structure complex problems using clear analytical frameworks and communicate findings with precision and clarity

• Develop executive-level presentations that clearly articulate strategic implications and possible courses of action

• Partner with senior leaders and business units to translate strategic hypotheses into clear options, trade-offs, and recommendations

Corporate Development & Inorganic Growth Support (Secondary Focus)

• Collaborate with Corporate Development peers to refine strategic themes that inform M&A, investments, and partnerships

• Support evaluation of inorganic opportunities through strategic rationale development, market analysis, and business case construction

• Contribute to due diligence efforts and cross-functional working groups as needed

• Help ensure alignment between long-term strategy and transaction-driven initiatives

Cross-Functional Leadership

• Manage complex working groups spanning product, engineering, finance, and business teams

• Act as a trusted thought partner to stakeholders across regions and functions

• Navigate ambiguity and drive progress across multiple initiatives with competing timelines

What We’re Looking For

• 6+ years of experience in corporate strategy, management consulting, corporate development, investment banking, or related strategic roles

• Strong strategic thinking skills with demonstrated ability to structure ambiguous problems and deliver actionable insights

• Advanced proficiency in Excel financial modeling and PowerPoint storytelling

• Experience developing executive-level materials for senior leadership decision-making

• Data-savvy mindset with the ability to identify key drivers and synthesize complex inputs into clear recommendations

• Excellent written and verbal communication skills with strong executive presence

• Ability to manage multiple projects simultaneously and adapt quickly to changing priorities

• Strong collaboration skills and comfort working across globally distributed teams

• Passion for gaming, entertainment, media, and technology strongly preferred

• MBA required 

#LI-SV1

At Blackbird Health our commitment is to provide personalized care, with powerful outcomes for children and families struggling with social developmental and school related challenges. Through an integrated community-centered care approach, our skilled clinical team delivers exceptional virtual and in-person care across a wide range of specialties. If you're excited to work for a mission driven start-up that values compassion, dedication and the holistic approach to care, Blackbird Health is a great place to advance your career.

ROLE DESCRIPTION

The Lead Neuropsychologist is a key clinical expert at Blackbird Health, providing direct care to children and families and helping build our service line offering. This position is responsible for providing advanced neuropsychological assessment and consultation services for children and families.  This leader drives clinical excellence and standardization, maintains the highest levels of clinical quality and compliance, and contributes to truly integrated care within Blackbird Health's multidisciplinary team. This role reports to the Senior Director, Specialty Services and collaborates closely with Clinical Leadership. 

This is a Remote role, with opportunity to be Hybrid at any of our clinic locations

Key areas of responsibility for the Lead Neuropsychologist will include:

Clinical Leadership and Oversight

• Lead the development and standardization of Blackbird’s Neuropsychology assessment protocols and standards.
• Conduct comprehensive neuropsychological evaluations for children with neurodevelopmental and school-related cases.
• Spearhead the expansion of diagnostic pathways for complex behavioral profiles, ensuring the service line is equipped to address a broad spectrum of developmental presentation types.
• Provide expert consultation to all members of treatment teams (Masters-level clinicians, social workers, Licensed counselors) on diagnostic formulation and therapeutic issues related to neurodevelopmental and cognitive profiles.
• Develop and implement Blackbird programs, protocols and standards related to the Neuropsychology service line.
• Help set and execute on key performance indicators for the Neuropsychology service.
• Maintain a consistent clinical presence, providing 24 hours of direct patient-facing clinical care per week focused on comprehensive evaluations.
• Consult on clinical issues as needed; and other duties as assigned.

Clinical Service Performance & Mentorship

• Own the clinical effectiveness and diagnostic quality of the Neuropsychological testing service line.
• Provide clinical direction and strategy for the evolution of specialized assessment tools used to identify cognitive differences and atypical developmental trajectories.
• As the service line grows, provide clinical supervision and mentorship to Neuropsychological testing staff.
• Drive clarity in assessment protocols and diagnostic formulation.
• Establish consistent clinical practices, including regular feedback, coaching, and performance reviews within the service line.
• Use data (e.g. assessment throughput, outcomes trends) to proactively identify and address clinical risks.

Quality and Compliance

• Ensure the delivery of high quality neuropsychological services and impeccable member safety.
• Monitor for compliance to all federal, state, accrediting agencies and payers as it relates to neuropsychology services.
• Ensure complete and timely documentation for all assessments and consultation notes.
• Lead internal clinical and quality initiatives that support the provision of consistent neuropsychological performance and practice standards across Blackbird.
• Intervene in any areas of underperformance related to neuropsychological services to develop and implement team or individual improvement plans.
• Design and lead performance management and peer review process for neuropsychology evaluations.

Training

• In collaboration with other leaders, develop effective organization-wide clinical training programs focused on neurodevelopmental and cognitive assessment.
• Provide group and one-on-one performance coaching and mentoring to clinical staff on interpreting and applying neuropsychological findings.

Program Design & Innovation

• In collaboration with the Clinical Executive Team, develop and execute an innovative and differentiated programmatic Neuropsychology service model.
• Identify opportunities to integrate gold-standard observational tools for social-developmental differences into existing workflows.
• Stay abreast of clinical innovations in neuropsychology and contribute ongoing discussions in these areas.
• Be an innovative thinker about the use cases of AI and remote models to enhance neuropsychological practice.

Marketing, Outreach and Clinical Content

• Serve as a clinical expert and brand ambassador of the Company for neuropsychology, presenting at clinical conferences and other national venues.
• Liaison with marketing team to contribute clinical content creation on neurodevelopmental issues and evolving diagnostic standards in the realm of social-emotional development.

QUALIFICATIONS AND COMPETENCIES

• Doctoral degree (Ph.D. or Psy.D.) in Clinical Psychology or School Psychology from an APA/CPA-accredited program required.
• Completion of a 2-year post-doctoral fellowship in Neuropsychology required.
• Licensed or license-eligible as a Psychologist in the state of practice required.
• Commitment to become certified in all states with a Blackbird Health presence
• Board Certification in Clinical Neuropsychology (ABCN) or eligibility is highly preferred.
• 1+ years of post-licensure experience conducting comprehensive pediatric neuropsychological evaluations.
• Demonstrated experience or specialized interest in the assessment of developmental differences.
• Ability to manage a robust clinical schedule, including 24 weekly patient-facing hours.
• Proven effective at leading and standardizing a specialized clinical service line.
• Computer Skills – Must be PC literate with proficiency in EHRs, spreadsheets, BI and similar reports, email, calendaring and word processing.
• Interpersonal/Communication Skills - Must be able to read, write and speak fluently and effectively in English. Effective in 1:1 and larger group meetings where emotional intelligence and effective communication are needed. Must have the ability to effectively present complex diagnostic information and respond to questions from management, staff, patients, vendors, and the general public. Strong customer service skills, attention to detail, and ability to multi-task required.
• Excellent clinical expertise and team leadership skills in client/patient care, specifically in neuropsychological assessment.
• Quality and Efficiency of Work – Accurately completes assigned work within the timeline designated, while making efficient use of the organization’s resources.
• Participation in all organizational performance improvement initiatives.
• Professionalism – Upholds client confidentiality and maintains professional boundaries, demeanor, dress and interaction with clients, family members, visitors and co-workers. The employee strives to provide outstanding customer service and promote a positive reputation for the organization.
• Ethical and Legal Compliance – Performs all duties to the highest ethical standard and complies with all organizational policies regarding ethical business practices and standards of patient care. The employee complies with all standards established by agencies accrediting the organization.
• Employee Partnership – Maintains collaborative peer relationships and demonstrates courtesy and respect of others. The employee acts as a role model by displaying enthusiasm, positive problem solving and commitment to help both co-workers and the organization reach its goals.

Your Core Responsibilities

• Collaborate with Traders to evaluate and enhance the performance of IMC’s existing proprietary trading models using advanced mathematical and analytical methods.
• Design quantitative methods to gather and analyze historical market data, trading statistics or new data sources and use the result of that research as the basis for new trading strategies.
• Translate trading strategies into mathematical models, algorithms, and other complex computational programs to realize the combined vision of the trading team.
• Build custom computational data analysis tools to explore new quantitative research ideas; design mathematical models to test, visualize and refine trading ideas before implementation.
• Apply rigorous analytical and quantitative techniques to solve complex problems presented by new and existing proprietary trading strategies.
• Coordinate with developers to implement new and improved quantitative trading models and launch them into production on IMC’s proprietary trading platform
• Conduct all quantitative trading research, development, and implementations according to internal best practices to keep IMC’s trading ecosystem logical and consistent.

Partial telecommuting permitted. Multiple positions available.

Quantitative Researcher (Requisition ID: 4453347101)

Your Skills and Experience

This position requires a PhD, or foreign equivalent, in Finance, Financial Mathematics, Financial Engineering, Statistics, Computational Mathematics or similarly quantitative and mathematical field.

Must have demonstrated experience in each of the following skill(s):

• Application of analytical and quantitative techniques to solve complex problems;
• Designing and implementing mathematical models and algorithms, including linear modeling, convex optimization, and numerical methods for large-scale data and parameter estimation;
• Developing and using computational data analysis tools for research;
• Statistical programming techniques (including Python or C++) and designing and executing independent quantitative research projects, including formulation of hypotheses, development of models, empirical testing, and clear documentation of results;
• Time series analysis, applied statistics, and theoretical mathematics (such as probability, measure theory/real analysis, and linear algebra);
• Implementing algorithms, conducting data analysis, and building research pipelines using numerical and scientific computing libraries (such as NumPy, pandas, SciPy) and version control (such as Git);
• Experience with time series modeling and forecasting, including stochastic processes and state-space or related frameworks, such as applied to real-world data; and
• Conducting literature reviews and replicating and extending prior work with methodological rigor and reproducibility.

#LI-DNI

Product Development – Skincare Category

The Product Development organization at SharkNinja drives our global product roadmap from concept to shelf through the constant lens of the consumer. As the “product CEOs,” we partner cross-functionally with nearly every team in the company to ensure high satisfaction for our end users and strong business outcomes. Our team is composed of product marketers, engineers, formulation experts, and consumer advocates—all united in delivering a 5-star experience for every product we launch.

Responsibilities

Drive new product development for the Skincare category, based onsite at our Needham, MA headquarters, from early-stage concept through to commercialization. This includes oversight of product formulation, packaging development, claims substantiation, regulatory readiness, and manufacturing scale-up. You will play a key role in executing product initiatives aligned with category growth and innovation goals.

- Manage day-to-day project progress and be accountable for reporting on key milestones, risks, testing results, and deliverables. Partner with senior leadership on overall category direction while owning execution for assigned product programs.

- Provide guidance and mentorship to junior team members (if applicable), supporting their development and fostering a high-performance team culture.

-  Collaborate closely with cross-functional partners including R&D/formulation, regulatory, packaging engineering, industrial design, sourcing, marketing, and quality to translate consumer needs and market opportunities into differentiated, high-performing skincare products.

- Leverage insights from the Insights & Intelligence team—including consumer research, clinical testing feedback, and market trends—to inform product positioning, claims strategy, and formulation decisions throughout development.

- Work with regulatory and quality teams to ensure all products meet global compliance standards (e.g., ingredient safety, labeling, claims substantiation) and establish robust testing protocols to validate efficacy, safety, and stability.

- Manage product costs in partnership with supply chain and sourcing teams to ensure margin targets are achieved without compromising performance or quality.

- Support development of go-to-market materials, including product claims, ingredient stories, usage instructions, and educational content to ensure clear, accurate, and compelling consumer communication.

- Partner with customer support and quality teams post-launch to monitor consumer feedback, manage any issues, and continuously improve the product experience.

- Serve as the category expert for your product line, providing clear and timely insights to internal stakeholders across sales, marketing, operations, and leadership.

Qualifications

• 5+ years of experience in product development, product marketing, formulation development, or a related field

• Experience in skincare, beauty, personal care, or other regulated consumer products preferred

• Bachelor’s degree (or equivalent experience) in Business, Chemistry, Chemical Engineering, Marketing, Life Sciences, or a related discipline

• Experience partnering cross-functionally with R&D, regulatory, quality, packaging, and manufacturing teams

• Familiarity with skincare development processes including formulation, stability testing, claims substantiation, packaging compatibility, and global regulatory compliance

• Demonstrated leadership through direct people management or by leading complex cross-functional initiatives

• Strong consumer-first mindset with passion for delivering clinically effective, high-quality skincare products

• Excellent communication skills with the ability to present clearly and persuasively across teams and leadership levels

• Highly organized with strong project management capabilities and the ability to manage multiple priorities in a fast-paced environment

• Comfortable navigating ambiguity, evolving formulations, and shifting priorities with a proactive, solution-oriented approach

ABOUT THE TEAM

Anduril's Lattice software platform integrates many sensors into a single cohesive view of the battlefield, providing the context our users need to make better decisions, faster. Perception Engineers on Anduril's Frontier AI team build edge-compatible systems that power these views, transforming complex multi-sensor inputs into accurate, actionable understanding of the world. We integrate ambitious machine learning and computer vision algorithms directly into the Lattice platform to increase the fidelity, accuracy, and usefulness of battlefield awareness. These systems improve the experience of Anduril's existing customers, aid in the scaling of our business to new customers, use-cases, and business lines, and they create high-quality snapshots of the world that autonomous and agentic systems can operate on top of.

WHAT YOU'LL DO

• Design, train, and deploy computer vision and perception models for edge-
  compatible, mission-critical environments
• Build multi-sensor perception systems that fuse imagery, video, and other sensor
  data into coherent views of the battlefield
• Improve the fidelity, accuracy, and robustness of Lattice's understanding of objects,
  activities, and environments across varied operational conditions
• Integrate state-of-the-art machine learning algorithms into production systems used
  by customers in real-world scenarios
• Develop mission-relevant evaluation frameworks, datasets, and benchmarks to
  measure perception performance in the field
• Partner closely with software, autonomy, product, and deployment teams to turn
  research ideas into operational capabilities
• Identify new perception and battlefield-understanding problems where advances in
  computer vision can unlock major product impact

REQUIRED QUALIFICATIONS

• BS, MS, or PhD in Computer Science, Robotics, Electrical Engineering, Machine
  Learning, or a related technical field
• 5+ years of experience developing computer vision, perception, or machine learning
  systems in production or advanced research settings
• Strong experience with deep learning, object detection, and object tracking
  frameworks
• Strong programming skills in Python, with the ability to build reliable research and
  production workflows
• Strong desire to invent, implement, test, and deploy novel techniques that vastly
  improve upon state-of-the-art public methods to solve research problem specific to
  the defense space
• Experience training, evaluating, and iterating on vision models for detection, tracking,
  segmentation, classification, or sensor fusion tasks
• Experience deploying or optimizing ML systems for constrained, real-time, or edge
  compute environments
• Ability to work across the full lifecycle of applied ML, from problem formulation and
  data strategy through deployment and performance monitoring
• Eligible to obtain and maintain an active U.S. Secret security clearance

PREFERRED QUALIFICATIONS

• Advanced degree with a focus on computer vision, perception, robotics, or machine
  learning
• Experience with multi-modal or multi-sensor fusion systems
• Experience deploying deep learning models to embedded, edge, or air-gapped
  environments
• Familiarity with real-time perception systems for autonomous platforms, defense
  applications, or other safety-critical systems
• Experience building large-scale datasets, labeling pipelines, or benchmarking
  infrastructure for vision systems
• Experience working in high-ownership startup environments or defense technology
  organizations
• Prior experience with geospatial, ISR, EO/IR, radar, or other battlefield-relevant
  sensing modalities

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Maintenance Technician (production, utilities, facilities) works as a key member of a high-performance team responsible for supporting daily manufacturing, utilities, and inspection & packaging operations in a pharmaceutical production environment. This position is 100% onsite at the Bloomington, Indiana facilities.

Responsibilities:

• Routine and non-routine checks and electrical/mechanical repair of production, utilities, and packaging & inspection equipment failures
• Troubleshoot and preventive maintenance
• Identify and implement continuous improvement projects
• Develop, monitor, and perform preventative maintenance procedures
• Review and track equipment component failures and help make recommendations for increased long-term reliability
• Maintain appropriate equipment documentation and change control according to internal procedures
• Participate in spare part analysis and inventory development
• Installation and startup of new equipment

Required qualifications:

• Must have a high school diploma or GED (Technical Associates degree preferred)
• 2-5 years industrial maintenance experience (or equivalent) in a multi craft environment - MAINTENANCE TECHNICIAN
• 5-8 years industrial maintenance experience (or equivalent) in a multi craft environment - SR. MAINTENANCE TECHNICIAN
• 8+ years industrial maintenance experience (or equivalent) in a multi craft environment and leadership/supervisory experience - LEAD MAINTENANCE TECHNICIAN
• Preferred experience in aseptic manufacturing environment
• Preferred HVAC/welding certification
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective as required.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment and hand tools is required
• Must be able to gown qualify for Grade A/B areas, as needed.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  •  Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for Automation Engineers (level depends on experience) that are responsible for leading the identification, implementation, optimization, and maintenance of process automation and controls systems in pharmaceutical processing, packaging, and facilities. These engineers ensure efficient, quality, functional, and compliant process automation systems and supports engineering systems, capital projects, technical services, and plant support, as applicable. These positions are 100% onsite at the Bloomington, Indiana facility and reports directly to the Sr. Manager, Automation Engineering.

The responsibilities:

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs
• Specify and configure ins
• Identify and drive improvement opportunities for equipment, instrument, and process optimization, efficiency, and cost reduction through automation technologies and lead initiatives to implement projects
• Lead the deployment of the full system lifecycle for process automation and control systems including the design, assessment, selection, commissioning, validation, and implementation of systems
• Troubleshoot automation and controls systems issues, conduct root causes analysis, and implement corrective actions to minimize downtime and ensure continuous operations
• Conduct risk assessments of automation and controls systems
• Ensure automation and controls systems meet regulatory requirements by conducting and assisting with validation activities

Required qualifications:

• BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field), plus 2+ years of relevant experience; or HS diploma/GED and 10+ years of relevant experience
• Work experience in process automation and controls systems (including programming PLCs, SCADA, and HMI systems) in pharmaceutical and/or manufacturing environments
• Experience in reading and interpreting electrical schematics and Process & Instrumentation Diagrams (P&IDs)
• Experience in Ignition SCADA/HMI
• Knowledge of coding in Rockwell and Siemens (PLCs and HMIs)
• Knowledge of automation and controls hardware and software systems
• Ability to prioritize projects and workload
• Excellent verbal communication and technical writing skills

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

POSITION OVERVIEW:

As Disc Medicine transitions from a clinical-stage organization to a commercial-stage one, the company is introducing a new role: Director of Clinical Quality Control. The successful candidate will play a crucial role in driving the company’s growth and achieving strategic objectives.

The Director of Quality Control will manage stability studies for various small-molecule and biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines. The primary functions include protocol design; coordination and execution of various stability studies at CDMOs; statistical analysis; and expiration dating.  Additionally, this role will oversee the end-to-end supply of reference standards for quality control testing, including sourcing/production, qualification, inventory and distribution, as well as lifecycle monitoring. Significant contributions from this role will be essential for facilitating regulatory filings of Disc Medicine assets.

This position reports to the Head of Analytical Development and Clinical Quality Control within the Technical Operations organization at Disc Medicine. The ideal candidate should have at least 10 years of experience in quality control management in the pharmaceutical or biotech industry.

RESPONSIBILITIES:

This role will have extensive technical expertise and be responsible for stability and reference standard management for Disc Medicine’s clinical development programs. The technical responsibilities include:

• Evaluate, select, and manage CDMOs for QC stability testing.
• Direct stability studies per ICH guidance, sample pulls, and data analysis to determine retest periods and product shelf-life.
• Create, revise, and approve SOPs, stability protocols, and reports in accordance with current GMP, ICH, and global regulatory guidelines.
• Create, implement, and manage stability databases, forecast stability testing, and report on metrics, perform data trending and statistical analysis to support expiry dating. 
• Manage Quality System records for QC Stability: create, assess, review Deviations, Change Controls, CAPAs, and other applicable stability-related investigations and events
• Oversee the sourcing, characterization, qualification, retesting, and inventory management of primary and working reference standards.
• Author and review the stability and reference standard sessions of the global health authority dossier for clinical trials and commercial licensure.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Establish and maintain a network of external partners to fulfill technical and capacity requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

 REQUIREMENTS:

• A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
• At least 10 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
• Knowledge of product stability, setting of specifications, product shelf-life management, and experience with QC OOS investigations.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with Veeva, LIMS and Smartsheet desirable.
• Knowledge of bioanalytical and analytical methods, including but not limited to LC-MS, GC-MS, UV-vis, IR/FT-IR, HPLC (SEC, icIEF), CE-SDS, ELISA, cell-based potency assays.
• Experience with method validation, method transfer, and hands-on management of day-to-day testing operations for outsourced small molecules and biologics therapeutics.
• Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and to present information in an advisory capacity.
• Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
• Able to travel up to 25%.
• Ability to work both independently and collaboratively with project teams and cross-functionally, to build productive relationships with internal and external partners, to influence decision-making, and to engage in conflict resolution.

Retail Product Development Manager

This role is hybrid to; NYC, Chicago, IL or Boulder, CO HelloFresh Headquarters

In addition to our core direct-to-consumer business, Factor_ has more recently expanded into the retail channel, making our meals available for purchase at brick-and-mortar stores. We are seeking a strategic, data-driven, and highly collaborative Retail Product Development Manager to own Factor_’s Retail Prepared Meals and adjacent food and beverage categories to support growth in this channel. In this pivotal role, you will champion the end-to-end retail product lifecycle—from driving overarching category strategy and formulation management to leading packaging design and continuous portfolio optimization. Acting as the ultimate product expert and a crucial cross-functional linchpin, you will partner seamlessly with Sales, Operations, DTC Product, and Nutrition teams to bridge deep consumer insights with specific retailer needs. Your core objective is to engineer a winning, scalable retail portfolio that commands attention on the shelf, drives exceptional sales velocity for our partners, and builds enduring brand loyalty through relentless, customer-centric innovation.

Key Responsibilities:

• Retail Product Strategy - Develop a winning retail prepared meals range consisting of core year-round SKUs, seasonal skus and may include the development of exclusive retailer ranges. Identify opportunities for expansion into adjacent categories based on retailer needs, white space and consumer research, as well as products available in our portfolio or ripe for development.
• Portfolio Lifecycle Management - Evaluate existing meals, conduct sales performance reviews, leverage online ratings and commentary as well as market trends to optimize our product portfolio by retailer. 
• Formulation & Spec Management - Ensure the retail product range can consistently be offered to retail partners by planning for necessary formulation, ingredient, and packaging changes, owning the spec creation and management process. 
• Packaging Design - Own packaging design for retail products, ensuring alignment with the broader F_ brand and packaging creative guidelines, meeting retailer compliance standards and functionality and appeal on shelf. 
• Sales Support - Support sales and review meetings with retailers as the product expert, sharing performance insights, industry trends, and product strategy and development opportunities.
• Cross-Functional Management - Partner with key members of the product team to ensure a strong understanding of the DTC product strategy, dietary lifestyles, consumer insights, and product development opportunities with the new formats team. Additionally, partner with operations, nutrition, FSQA, sourcing, retail team members, etc. to ensure the successful management of our retail program.

You are…

• A problem solver - You are resourceful and scrappy and aren’t afraid to roll up your sleeves and figure it out. Where a process doesn’t exist, you’ll create one.  
• Curious & Passionate about Product - you are always looking to learn more about the industry, new products and ways we can delight our customers.
• Data-driven to the core and leverage data to make key business decisions. 
• Detail-oriented – You possess strong organizational skills and demonstrate a methodical approach to your work, documenting new processes.
• A project manager - You have excellent project management skills leading groups, as well as a demonstrated ability to meet deadlines and complete deliverables on time.
• A critical thinker – You use logic to identify opportunities, evaluate alternatives, and present critical information to solve complex problems.
• Highly collaborative - You enjoy working collaboratively with cross-functional teams to get things done.

At a minimum, you have...

• Bachelor degree in Business Administration or other relevant field of study.
• Minimum of 5 years of relevant experience with a background in physical product management, category management, product marketing or strategic sourcing across food/food tech or CPG industries.
• Strong preference for experience within CPG or retail product development.
• Fluent in Google Suite applications (especially sheets & slides), tableau, Gemini and an ability to quickly learn and leverage a range of other databases and tech tools. 
• Familiarity with retail data platforms (NIQ, SPINS, or Circana/IRI) to track category performance and support buyer conversations.
• Ability to successfully manage multiple cross-functional stakeholders as well as to present to executive level colleagues.
• Success in collaborating with cross-functional teams to get things done
• Travel: <10%

You’ll get…

• Competitive salary, 401k with company match that vest immediately upon participation, and company equity plan based on role
• Generous PTO, including sabbatical, and parental leave of up to 16 weeks
• Comprehensive health and wellness benefits with options at $0 monthly, effective first day of employment
• Tuition reimbursement for continuing education (upon 2 years of service)
• Up to 85% discount on subscriptions to HelloFresh meal plans (HelloFresh, Green Chef, Everyplate, and Factor_)   
• Access to 7 different Employee Resource Groups (ERGs) including those for BIPOC, women, veterans, parents, and LGBTQ+
• Inclusive, collaborative, and dynamic work environment within a fast-paced, mission-driven company that is disrupting the traditional food supply chain

This job description is intended to provide a general overview of the responsibilities. However, the Company reserves the right to adjust, modify, or reassign work tasks and responsibilities as needed to meet changing business needs, operational requirements, or other factors.

Our company is committed to fair hiring practices and complies with all applicable laws, including the Colorado Job Application Fairness Act (JAFA). In accordance with JAFA, we will not request your age, date of birth, or dates of attendance at or graduation from an educational institution on your initial application for employment.

The Construction Manager will oversee multiple construction and CAPEX projects. This will include capital improvement projects, retrofits & renovations, and new builds. The Construction Manager will be responsible for managing design, planning (cost & schedule), and execution (quality assurance and job site safety & compliance) for our current & future HelloFresh Fulfillment Centers.  You will manage enhancement projects and building construction to make our facilities best in class! 

You will… 

• Manage planning and execution of capital construction projects
• Responsible for the financial management of assigned projects that can be in excess of $10M
• Play a critical role in formulation of construction budget; develop RFPs, negotiate terms and conditions with professional entities.
• Manage review process of all project design documents (drawings and specifications) 
• Establish agreed upon project expectations and adherence to the approved budget and work effectively with end user(s), such as Fulfillment Operations, Engineering, Logistics, etc. - and other necessary outside professionals (architects, engineers, developers, estimators, equipment planners, etc.) to establish the  scope and budget for a project
• Liaise with outside contractors regarding bidding, planning, scheduling, and execution 
• Make frequent site visits to survey the progress of work on all assigned construction projects to assure quality control & monitor performance to contract. 
• Interface with local/state agencies regarding permits and inspections 
• Monitor performance of contracts and recommend payment for appropriate services rendered. This includes review and submission of all letters of approval, invoices, change orders, support documentation, etc. 
• Manage business relationships with external contractors. 
• Prepares project status reports regularly and effectively communicates the status of all major & minor construction projects to Leadership and stakeholders. 

You are… 

• Data-driven – make decisions based on facts rather than gut-feelings
• A connector of complex problems at all levels through excellent written and verbal skills
• Impeccable organization, detail, and project management
• Agile - works in an ever-changing environment; demonstrates a data-driven focus in all work.
• Experienced in leading teams and encouraging collaborations at all levels and departments of an organization.
• A natural owner - Super reliable and thoughtful in managing your responsibilities, cares about the outcome and quality of work and earns the trust of your colleagues
• Customer-focused: aim to achieve a customer experience and product that is second to none
• Communicative and send clear messages verbally and in written form to set direction, and convey updates on issues, operational status, and goals during daily/weekly stand-ups and leadership reviews
• Equipped to manage projects, gather data, organize ideas, form recommendations and implement solutions
• Dedicated to providing the best possible experience for the HelloFresh customer 

You have… 

• Degree in Construction Management, Architecture, Engineering or a related field a plus 
• 4+ years’ experience in construction or project management,in e-commerce fulfillment/distribution experience preferred.
• Food industry experience a plus but not required 
• Significant working knowledge of Federal, State, and local laws and regulations related to facility buildouts 
• Experience managing multiple projects of scope and scale simultaneously 
• Proven history negotiating contracts for facility expansion (contractors, sub-vendors, landlords, permit offices, site management, etc.) 
• Understanding of Building, Mechanical, Electrical, and Plumbing Codes 
• Proficient in Microsoft Word and Excel 
• Ability to read and interpret complex construction drawings 
• Excellent verbal and written communication skills 
• Requires heavy travel to assigned project locations (50 - 80%)

You’ll get…

• Competitive hourly rate, 401K company match that vests immediately upon participation, & team bonus opportunities
• Generous PTO and flexible attendance policy 
• Comprehensive health and wellness benefits with options at $0 monthly, effective first day of employment
• Up to 85% discount on subscriptions to HelloFresh meal plans (HelloFresh, Green Chef, Everyplate, and Factor_)   
• Access to Employee Resource Groups that are open to all employees, including those pertaining to BIPOC, women, veterans, parents, and LGBTQ+
• Inclusive, collaborative, and dynamic work environment within a fast-paced, mission-driven company that is disrupting the traditional food supply chain

This job description is intended to provide a general overview of the responsibilities. However, the Company reserves the right to adjust, modify, or reassign work tasks and responsibilities as needed to meet changing business needs, operational requirements, or other factors.

Our company is committed to fair hiring practices and complies with all applicable laws, including the Colorado Job Application Fairness Act (JAFA). In accordance with JAFA, we will not request your age, date of birth, or dates of attendance at or graduation from an educational institution on your initial application for employment.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.

The responsibilities:

• Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
• Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes
• Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment
• Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
• Collaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design
• Develop and maintain project schedules using MS Project
• Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
• Provide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment
• Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders
• Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence

Required qualifications:

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
• 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)
• 0-2 years of experience (Level I)
• 2-5 years of experience (Level II)
• 5-8 years of experience (Level III/Sr.)
• 8+ years of experience (Level IV/Principal)
• Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices
• Must be able to lead and execute engineering projects
• Strong understanding of packaging materials, processing, and testing methods
• Experience with PLC, HMI, Vision Systems and Building Management systems
• Strong oral and written communication skills
• Must be able to read mechanical, electrical, and P&ID drawings
• AutoCAD or equivalent component design knowledge
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)

 Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

ABOUT THE TEAM

Anduril’s Tactical Recon & Strike (TRS) is a division with two missions: 1) build highly capable autonomous drones, and 2) build solid rocket motors at scale. We transform products like Ghost, Anvil, Bolt, and Altius from early concepts into fully operational capabilities by partnering closely with specialist engineering, operations, and production teams. Through our Anduril Rocket Motor Systems (RMS) team, we design and manufacture solid rocket motors using advanced materials, proprietary formulations, and high-volume production methods—delivering safe, reliable propulsion systems that support a wide range of mission requirements. TRS hires software engineers & hardware engineers, who are excited to build across a diverse and powerful portfolio—from autonomous aerial systems to high-performance solid rocket motors. Our teams contribute to highly capable autonomous robotics systems and propulsion products that operate reliably in the most demanding mission environment.

ABOUT THE JOB

Anduril – Rocket Motor Systems is seeking a Formulations Manager to join our organization. The Rocket Motor Systems group designs, develops, and manufactures next-generation solid rocket motors for defense and space applications at Anduril. The ideal candidate has both experience with energetic materials and solid composite propellant manufacture and formulation and previous technical functional management experience. This role requires in-depth knowledge of propellant chemistry/processing, robust experience in rocket motor testing, and the ability to lead and mentor a team of formulators.

WHAT YOU’LL DO

• Lead a team of 3-5 formulators in executing production, development, and research propellant programs and projects.
• Maintain compliance of acceptable explosive sensitivity limits for safe scaleup and manufacture of multiple solid propellant formulations.
• Manage group budget and properly allocate resources to ensure the success of critical contracts and efforts.
• Regularly create new processes and procedures from scratch and implement them across a rapidly-growing business line.
• Act in an approval role for business-critical functions such as:
• statement of work accuracy.
• energetic operations safety board.
• material acceptance, compatibility, and sensitivity.
• capital expenses including new buildings/facilities, new equipment, and new chemical instrumentation.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Chemistry, Chemical Engineering, Aerospace Engineering, or a related field.
• U.S. citizenship is required as this position will access export-controlled and sensitive data.
• Ability to obtain a security clearance.
• Demonstrated technical leadership and ability to solve complex problems.
• Demonstrated problem-solving skills and the ability to operate in a fast-paced, challenging environment.
• Demonstrated technical leadership and execution.

Preferred Qualifications

• Demonstrated expertise in rocket motor manufacture, composite propellants, and energetic materials.
• Active DOD Secret or Top Secret security clearance.

ABOUT THE TEAM

The Security Team at Anduril is the cornerstone of defense, employing unparalleled security measures and state-of-the-art technology to ensure the protection of our people, assets, operations, and innovations. Given the unique nature of this company, our team support a host of standard and non-standard taskings integrating physical and digital measures to stay ahead of evolving threats. We also uphold stringent industry and government compliance, creating a secure environment that nurtures the development of cutting-edge defense solutions and ensures Anduril's continued growth and innovation in a complex global landscape.

ABOUT THE JOB

We are seeking a highly accomplished and resourceful Strategy and Operations generalist to join our Security department.

In this role, you will work with Anduril's Security leaders across the organization, as well as other cross-functional stakeholders, to both manage operations and lead special projects for the Security department. Work within this role includes quick-turn operational fire-fighting, solving messy problems, redesigning and implementing processes, and leading high-impact strategic projects. You will frequently be pulled into high-priority initiatives that do not fall neatly into the purview of an existing person's job description.

WHAT YOU'LL DO

• Architect and lead high-impact strategic initiatives across the Security organization, translating complex, ambiguous problems into structured frameworks, actionable strategies, and measurable outcomes.
• Drive end-to-end operational programs from conception through implementation, independently defining scope, navigating significant ambiguity, and ensuring successful delivery against critical timelines. You will be handed ambiguous, messy problems with little prescription on how to solve them. If this does not excite you, this is not the role for you.
• Pioneer the design and implementation of next-generation processes, tools, and systems that enhance operational maturity, streamline workflows, and ensure the Security organization is scalable and resilient for future growth.
• Power the process and tooling innovation engine for the Security org. Define and lead operational excellence initiatives around key areas that will help us operationalize, streamline, improve and scale as we continue to grow.
• Spearhead complex change management efforts for critical departmental initiatives, ensuring successful adoption and sustained impact through strategic communication, comprehensive training, and robust stakeholder alignment.
• Drive the design and implementation of new holistic and streamlined processes, tools and systems, ensuring they foster a holistic and unified Security Organization, meet business requirements and are built for scale.
• Develop and deploy sophisticated data analytics and reporting frameworks that provide Security leadership with actionable insights, inform strategic decision-making, and drive continuous operational improvement.
• Serve as a trusted advisor and primary strategic liaison to Security leadership and cross-functional executives, preparing high-impact materials and facilitating critical discussions to align objectives and drive key organizational decisions.
• Strategically plan and execute critical departmental operations, including annual strategic planning cycles, budget formulation, and high-visibility internal business reviews, contributing to the overall effectiveness and strategic direction of the Security organization.
• Orchestrate and facilitate high-stakes executive engagements, developing compelling narratives and data-driven pre-reads to ensure strategic alignment, influence decision-making, and drive critical initiatives forward.
• Provide strategic oversight and ensure accountability for critical departmental initiatives, proactively identifying risks, resolving roadblocks, and driving cross-functional alignment to maintain strategic momentum and achieve desired outcomes.

REQUIRED QUALIFICATIONS

• You have 6-8+ years of progressive experience in management consulting, operations, strategic finance, or product/program management, demonstrating a trusted track record of impact in complex, fast-paced environments.
• You're both high ownership and low ego, approaching everything with a relentless outcome orientation and profound humility.
• You have exceptional emotional intelligence and the ability to solve complex operational problems not only from a data-driven lens, but also by adeptly building and leveraging strong cross-functional relationships across the company.
• You are inherently self-driven, relentlessly proactive, and demonstrate an exceptional bias for action. You don't need someone to tell you to "move"; you anticipate needs and act decisively.
• You thrive as a strategic thought partner, translating intricate operational challenges into structured data problems and executing robust solutions.
• You possess a proven ability to architect clear frameworks to structure highly ambiguous and complex problems.
• You are equally adept at diving deep into tactical execution with meticulous attention to detail and organization while simultaneously maintaining a 30,000-foot strategic perspective to solve high-level organizational challenges.
• You consistently seek and integrate feedback, demonstrating a strong commitment to continuous growth and personal development.
• You are a master communicator capable of articulating complex concepts clearly and simply across all levels, from front-line operators to the executive suite, with demonstrated expertise in strategic stakeholder and executive engagement.
• You possess the exceptional capacity to lead and manage multiple concurrent, high-priority strategic initiatives at a rapid pace, consistently delivering results with meticulous attention to detail and proactive communication.
• Exceptional analytical acumen with a proven ability to perform deep financial modeling, operational analysis, and strategic forecasting to inform critical business decisions.
• Demonstrated proficiency or rapid aptitude for mastering complex operational tools and platforms, including (but not limited to) Airtable and Foundry, for data management, reporting, and dashboarding.
• Ability to work onsite five days a week at our HQ in Costa Mesa, CA and willingness to travel 25% - 50% to support project objectives as needed.
• Ability to obtain and maintain a U.S. Top Secret security clearance.

ABOUT THE TEAM

Anduril’s Tactical Recon & Strike (TRS) is a division with two missions: 1) build highly capable autonomous drones, and 2) build solid rocket motors at scale. We transform products like Ghost, Anvil, Bolt, and Altius from early concepts into fully operational capabilities by partnering closely with specialist engineering, operations, and production teams. Through our Anduril Rocket Motor Systems (RMS) team, we design and manufacture solid rocket motors using advanced materials, proprietary formulations, and high-volume production methods—delivering safe, reliable propulsion systems that support a wide range of mission requirements. TRS hires software engineers & hardware engineers, who are excited to build across a diverse and powerful portfolio—from autonomous aerial systems to high-performance solid rocket motors. Our teams contribute to highly capable autonomous robotics systems and propulsion products that operate reliably in the most demanding mission environment.

ABOUT THE JOB

Anduril – Rocket Motor Systems is seeking a Lead Scientist to join our organization. The Rocket Motor Systems business line designs, develops, and manufactures next-generation solid rocket motors for defense and space applications. The ideal candidate has extensive experience with numerous types of energetic materials and demonstrated expertise in one area of solid composite propellant manufacture and formulation. This role requires considerable knowledge of energetic materials chemistry, significant experience in rocket motor manufacturing, and demonstrated effectiveness as the principal investigator on internal research and development efforts.

WHAT YOU'LL DO

• Execute production rocket motor contracts as the program propellant chemist.
• Act as the principal investigator on at least one internal research and development effort.
• Provide technical guidance on explosives chemistry and manufacturing.
• Maintain databases and analyze technical data to ensure specification and regulatory compliance.
• Support implementation of innovative techniques and technologies.

REQUIRED QUALIFICATIONS

• Ph.D. in Chemistry, Chemical Engineering, Aerospace Engineering, or a related field plus two years of experience; or a master’s degree plus four years of experience; or a bachelor’s degree plus six years of experience.
• Minimum of two years of relevant experience within the aerospace/defense industry, preferably in solid rocket motor production.
• Demonstrated expertise in some area of rocket motor manufacture, e.g., composite propellants, energetic materials, case/nozzle/insulation design, solid rocket motor manufacturing.
• Demonstrated problem-solving skills and the ability to operate in a fast-paced, challenging environment.
• Ability to obtain and hold a U.S. Secret Security Clearance

PREFERRED QUALIFICATIONS

• Ph.D. or M.S. in Chemistry with a concentration in energetic materials, polymer chemistry, or reactive materials.
• Minimum of three years of relevant experience within the aerospace/defense industry, preferably in solid rocket motor production.
• Demonstrated experience formulating propellants at laboratory or production size.
• Active DOD Secret or Top-Secret security clearance.
• At least one publication or presentation within the defense industry in a relevant journal or at a relevant conference.

ABOUT THE TEAM

Anduril’s Tactical Recon & Strike (TRS) is a division with two missions: 1) build highly capable autonomous drones, and 2) build solid rocket motors at scale. We transform products like Ghost, Anvil, Bolt, and Altius from early concepts into fully operational capabilities by partnering closely with specialist engineering, operations, and production teams. Through our Anduril Rocket Motor Systems (RMS) team, we design and manufacture solid rocket motors using advanced materials, proprietary formulations, and high-volume production methods—delivering safe, reliable propulsion systems that support a wide range of mission requirements. TRS hires software engineers & hardware engineers, who are excited to build across a diverse and powerful portfolio—from autonomous aerial systems to high-performance solid rocket motors. Our teams contribute to highly capable autonomous robotics systems and propulsion products that operate reliably in the most demanding mission environment.

ABOUT THE JOB

As Senior Scientist, you will support the development of Anduril’s proprietary metal-powder fuel formulation through chemical and materials research and development. The right person for this role has hands-on skills in chemical and materials research and development and also in project management. If you are someone who is detail oriented and passionate about turning laboratory development into next-generation, real-world capabilities this role is for you.

WHAT YOU’LL DO

• Conduct experimental research under the guidance of a senior principal scientist.
• Collaborate with a multi-specialized team.
• Analyze data & plan experiments & make brief technical presentations.
• Support multi-threaded project management.

REQUIRED QUALIFICATIONS

• Master’s degree in chemical, materials science, or metallurgical engineering, chemistry, or related fields.
• Experience with air-sensitive chemistries, materials and techniques.
• Fundamental knowledge of material and chemical sciences.
• Experience in team-oriented project execution.
• Eligible to obtain and hold a U.S. Top Secret Security Clearance.

PREFERRED QUALIFICATIONS

• Ph. D degree in chemical, materials science, or metallurgical engineering, chemistry, or related fields.
• A preference for inorganic chemistry, metallurgical engineering, or material science.
• Experience with reactive metals
• Experience with surface chemistry.
• Experience with team project leadership & management. Well-developed soft skills for technical project collaboration.
• Experience with materials characterization techniques and interpretation (ICP, gravimetric analysis, microscopy, DSC, spectrometry, etc.).
• Experience with propellant or energetic materials.

Summary:

Vaxcyte is seeking an energetic and talented individual to join the Drug Product (DP) Process Development team within the broader Process Development organization. The primary responsibility of the incumbent will be to provide technical and engineering support across DP process development activities, spanning late-stage clinical supply, process characterization, tech transfer, and commercial readiness (PPQ) of Vaxcyte’s lead programs. The role requires close collaboration with internal cross-functional partners (Formulation, Analytical Development, MSAT, Quality) as well as external contract development and manufacturing organizations (CDMOs) supporting Vaxcyte’s fill/finish operations.

Due to the high number of Drug Substances (up to 31) within the DP and the aluminum-containing adjuvant system, this is arguably one of the most complex Drug Products in clinical and commercial development today, offering the right candidate an incredible opportunity to make a significant impact on the product, the company, and the industry. The successful candidate will be hands-on, detail-oriented, and comfortable operating in a fast-paced environment with fluid priorities. The role is predominantly lab- and office-based at Vaxcyte’s San Carlos headquarters, with opportunities to contribute to studies executed at both internal and external (CDMO) sites.

Essential Functions: 
•    Support the development, characterization, and qualification of robust Drug Product processes for late-stage clinical and commercial manufacturing.
•    Execute bench- and pilot-scale process development studies using down-scaled models, including compounding/mixing, sterile filtration (filter selection and sizing), fill/finish, hold time, and container/closure evaluations. 
•    Perform in-process sample testing and analysis of DP intermediates and finished product to support process monitoring, process characterization, and release.
•    Maintain accurate and timely data entry and documentation in Benchling (ELN) in accordance with Good Documentation Practices (GDP), ensuring accuracy, completeness, and compliance with established standards and regulatory requirements.
•    Analyze experimental and manufacturing data using statistical tools (e.g., JMP), identify trends, and summarize findings in technical reports and presentations.
•    Perform routine lab upkeep and housekeeping to ensure laboratory cleanliness standards are met and conduct regular inventory monitoring and reconciliation.
•    Work within a team environment and provide support as necessary to further the team’s initiatives.

Requirements: 
•    BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
•    Experience in, or exposure to, early- and/or late-stage clinical fill/finish manufacturing under GMP regulations preferred.
•    Working knowledge of Drug Product unit operations, such as compounding/mixing, sterile filtration, aseptic fill, and container/closure systems (vials, PFS, cartridges).
•    Experience supporting technology transfer, scale-up/scale-down, process characterization, or CDMO-based manufacturing activities is preferred.
•    Familiarity with statistical analysis tools (e.g., JMP, Minitab) is preferred.
•    Experience using electronic lab notebook (ELN) systems, preferably Benchling, is a plus.
•    Strong interpersonal and communication skills, both verbal and written, with the ability to work effectively with internal cross-functional teams.
•    Ability to work independently and collaboratively in a fast-paced, cross-functional environment, managing multiple priorities simultaneously.
•    Ability to execute, document, and interpret drug product process development and characterization experiments, adhering to scientifically sound practices.
•    Strong technical writing, data analysis, and communication skills.

Reports to: Engineer I, Drug Product Process Development

Location: San Carlos, CA

Expected Contract Length: 12 months

Hourly Range: 51/hr. – 56/hr. 

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Quality Auditor is a member of the Quality Assurance Team reporting directly to the Sr Manager, Quality Auditing. They conduct internal audits ensuring compliance with all applicable cGMP regulations, processes, systems and provisions of the Quality System. They host and manage regulatory authority and client inspections. They serve as a technical expert within the Quality Auditing department. They are responsible for results in terms of quality system conformance to regulations and Simtra quality policies.

The responsibilities:

 Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Ensures that audit schedules are produced and communicated in a timely fashion. Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines. This includes review of updated GMP regulations and current FDA and outside of US requirements and incorporation into internal programs, where appropriate.

• Leads/supports Client audits of the facility. Prepares for the audit/assessment activity by researching background information, including previous audit results. Assists in reviewing audit responses. Maintains the assessment file through the process to closure.
• Supports routine GMP and Pre-Approval Inspection regulatory audits. Prepares for audits by coordinating documentation, arranging facility tours, reserving conference rooms, and communicating with facility subject matter experts. Assists in pre- and post- audit communications with Global Quality and regulatory bodies. Interfaces with regulatory inspectors during audits.
• Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness.
• Conducting and confirming follow-up actions on Corporate, Client, Regulatory and Internal site compliance audits. Reports extended corrective actions to management.
• Performs procedure gap assessments to ensure compliance with Global Quality procedures.
• Maintains and makes recommendations for improvement to Quality procedures.
• Performs desktop evaluations of site’s suppliers per Global Quality procedures.
• Considered a Subject Matter Expert for department.
• Mentors other auditors.
• Trains subject matter experts for inspection readiness.

Qualifications:

• Bachelors degree required.  Preferably in a science or technical discipline.
• Minimum 5 years experience in the pharmaceutical industry, which should include at least 3 years of auditing experience.
• ASQ and/or RAB auditor accreditation is strongly desired.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral.
• Work effectively independently and in team environment.
• Must demonstrate sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations.
• Ability to demonstrate strong organizational skills.
• Good working knowledge of Windows based applications.
• Resourceful, self-reliant, self-motivated and confident.
• Working knowledge of quality software system (e.g. TrackWise, Veeva).
• General knowledge of Lean Six Sigma and other continuous improvement tools.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are seeking a highly experienced and strategic Senior Database Administrator (DBA) and enterprise application architect to join our IT team. The ideal candidate will bring over fifteen years of hands-on expertise in Oracle Database Administration, MS SQL Server, and multi-platform enterprise application  environments such as Oracle, SAP, JDEdwards, on different operating systems including Linux/Unix and Windows. This role also requires deep technical knowledge of application architecture, datacenter infrastructure, including networking, virtualization, and enterprise storage systems. The Senior DBA and architect will play a key role in architecting and designing database and infrastructure solutions, providing day-to-day operational support, and leading technical delivery of complex projects to support our enterprise applications.

What you'll be doing:

• Architect and design scalable, secure, and high-performance database solutions across Oracle and MS SQL Server platforms.
• Lead the architecture and integration of database systems with datacenter technologies including networking, virtualization, and storage.
• Provide day-to-day support for production, development, and test database environments, ensuring optimal performance and uptime.
• Collaborate with infrastructure, application, and security teams to align database and datacenter strategies with business goals.
• Lead the technical delivery of database and infrastructure projects, including upgrades, migrations, and consolidations.
• Develop and enforce database standards, best practices, and security policies.
• Perform capacity planning, performance tuning, and disaster recovery planning.
• Troubleshoot and resolve complex issues across database, OS, network, and storage layers.
• Ensure core enterprise applications are performing at optimal speeds and are fully backed up and redundant.
• Mentor junior DBAs and technology managers to serve as a subject matter expert across all IT teams.

Technical Skills & Expertise:

Enterprise Applciations:

• JDEdwards
• Oracle Applications
• D365
• SAP
• PTC
• Siebel
• Salesforce
• Workday
• Other HRIS Platforms

Database Platforms:

• Oracle: 10g, 11g, 12c, 19c
• MS SQL Server: 2008, 2012, 2016, 2019, 2022
• Postgres
• NoSQL Databases
• ODBC
• Reporting Replicas
• Datawarehousing Techniques
• Snowflake
• PL/SQL, T-SQL, SQL performance tuning

Operating Systems:

• Unix/Linux: Solaris 5, AIX, RHEL, CentOS
• Windows Server: 2003, 2008, 2012, 2016, 2019, 2022

Datacenter Technologies:

• Networking: TCP/IP, DNS, DHCP, VLANs, firewalls, load balancers
• Virtualization: VMware vSphere/ESXi, Microsoft Hyper-V, Oracle VM
• Storage: SAN/NAS, RAID, Fibre Channel, iSCSI, NetApp, EMC, Dell EqualLogic

Cloud Technologies:

• AWS
• Azure
• Datalakes
• Data Lakehouses
• Data warehouses

Scripting & Automation:

• Bash, PowerShell, Python (for automation)
• Infrastructure automation tools (e.g., Terraform, preferred)

Preferred Certifications:

• Oracle Certified Professional (OCP)
• Microsoft Certified: Database Administrator
• VMware Certified Professional (VCP)
• Red Hat Certified Engineer (RHCE)

What you'll bring:

• 15+ of experience in life sciences, pharma or biotech
• 15+ years of leadership in technology & architecture
• Ability to travel internationally as necessary.

Physical / Safety Requirements

• Position requires sitting for long hours, but may involve walking or standing for periods of time

In return, you’ll be eligible for[1]:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Additional Benefits
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

About this Role

Varda Space Industries is seeking a motivated Research Associate to provide critical laboratory support for our biologics formulation team. This role will focus on preparation of stock solutions, maintenance of laboratory equipment, and execution of analytical testing to support ongoing protein formulation development activities. The ideal candidate will have hands-on experience in biopharmaceutical laboratory operations and familiarity with protein characterization techniques.

Key Responsibilities

Laboratory Operations & Supply Chain Support

• Prepare and maintain stock solutions for formulation development activities 
• Manage laboratory chemical inventory and coordinate with supply chain to ensure uninterrupted operations 
• Monitor equipment status and maintain laboratory instruments in working order 
• Execute solution preparation according to established Standard Operating Procedures (SOPs) 
• Support laboratory organization and cleanliness to maintain GLP-ready environment 

Analytical Testing & Sample Preparation

• Conduct analytical characterization of protein formulations 
• Prepare reagents, buffers, and sample sets in advance to ensure experiments run on schedule  
• Perform routine calibration, qualification, and preventive maintenance on laboratory instruments  
• Maintain accurate, GxP-compliant records in laboratory notebooks and electronic systems  
• Collaborate with Scientists on the design, setup, and pull-points of stability studies 

Team Collaboration

• Work closely with formulation scientists to anticipate laboratory needs 
• Communicate inventory requirements and potential supply issues proactively 
• Participate in team meetings and contribute to continuous improvement initiatives 

Basic Qualifications

• Bachelor's degree in Biochemistry, Pharmaceutical Sciences, Biotechnology, or related field
• 1-3 years of experience in biopharmaceutical or academic research laboratory settings
• Hands-on experience with protein preparation and handling
• Knowledge of basic analytical techniques for protein characterization
• Strong attention to detail and ability to follow SOPs precisely
• Excellent organizational skills and ability to manage multiple priorities
• Effective written and verbal communication skills
• Proficiency with electronic laboratory notebooks and data management systems

Preferred Skills and Experience

• Master's degree in Biochemistry, Pharmaceutical Sciences, Biotechnology, or related field
• Experience in formulation development or protein drug product development
• Familiarity with biophysical characterization instruments (DLS, viscometry, capillary electrophoresis)
• Previous experience working in GLP-compliant environments
• Knowledge of monoclonal antibodies or therapeutic proteins

Pay Range

• Pay Range: $28.00 - $45.00/per hour
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for incentives in the form of stock options and/or long-term cash awards

Position Summary:

ultraimpact – Make a difference for those who need it most

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

We are seeking a motivated undergraduate/graduate student to join our AAV Purification Process Development team. The successful candidate will support laboratory and data‑driven activities that directly contribute to commercial manufacturing, process development, and clinical compatibility studies. This position offers hands‑on experience in gene therapy purification process development, exposure to GMP‑aligned development workflows, and the opportunity to learn industry‑relevant skills in various purification unit operations, clinical device compatibility, and industry relevant data analysis

• Actively contributes to programs in late-stage development to enhance AAV manufacturing technologies/capabilities and work-processes.
• Collect controlled experimental data and maintain accurate daily logs of experiments including methods, results, and conclusions.
• Conduct laboratory studies to support commercial manufacturing needs, including column and resin lifetime extension studies.
• Support development activities for AAV downstream processes, including buffer screening, filtration studies, and chromatography evaluations.
• Contribute to clinical in‑use compatibility studies, supporting material preparation, sample handling, and execution of defined protocols (as needed).
• Prepare buffers and solutions according to established procedures to support ongoing experiments and team operations.
• Support data management by compiling, organizing, and formatting process data
• Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports.
• Present scientific findings to the downstream and formulation development group or broader internal audience.
• Assist in general laboratory maintenance duties, including inventory of consumables and raw materials, buffer preparation, and routine lab maintenance/cleaning tasks.

Requirements:

• Graduate or Undergraduate student in Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline.
• This is a 6 month co-op, starting July 6, 2026 working full-time (40 hours per week) until December 18, 2026
• Strong interest in bioprocessing, AAV/gene therapy, or downstream purification.
• Experience working with chromatography and filtration systems is a plus.
• Interest in learning and working in a fast-paced environment.
• Ability to follow protocols carefully and maintain attention to detail.
• Demonstrates strong organizational and communication skills and the ability to work effectively in a collaborative team environment.
• Independently motivated and detail-oriented with good problem-solving ability.

U.S. Hourly Wage Range: 

• $23.00-$30.00/hour. The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s school year/level.

#LI-AJ1     #LI-Onsite

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Senior Maintenance Technician - Packaging works as a key member of a high-performance team responsible for supporting daily packaging operations and equipment in a pharmaceutical production environment.  This position reports to the Automation Supervisor.

.
The responsibilities:

• Routine and non-routine checks and electrical/mechanical repair of packaging equipment failures
• Troubleshoot and preventive maintenance of packaging equipment
• Identify and implement continuous improvement projects
• Develop, monitor, and perform preventative maintenance procedures
• Review and track equipment component failures and help make recommendations for increased long-term reliability
• Maintain appropriate equipment documentation and change control according to internal procedures
• Participate in spare part analysis and inventory development
• Installation and startup of new equipment

What you'll need:

• Must have a high school diploma or GED (Technical Associates degree preferred)
• 5+ years industrial maintenance experience (or equivalent) in a multi craft environment
• Preferred experience in aseptic manufacturing environment
• Preferred HVAC/welding certification
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective as required.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment and hand tools is required
• Must be able to gown qualify for Grade A/B areas, as needed.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance 
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The CAPA Manager is responsible for leading and managing the Corrective and Preventive Action (CAPA) Quality System to ensure compliance with corporate, client, and regulatory requirements. This role oversees investigations, root cause analysis, and implementation of effective corrective and preventive actions across the organization. The CAPA Manager collaborates with cross-functional teams and serves as a key point of contact for CAPA-related activities. This position reports to the Sr. Manager, Quality.

The responsibilities:

• Serve as the CAPA Program Owner, ensuring compliance with corporate and regulatory guidelines.
• Oversee day-to-day operation of the CAPA Quality System, including recurring CAPA meetings and timely closure of CAPAs.
• Lead and facilitate investigations for deviations.
• Utilize structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA) to identify root causes and implement effective corrective/preventive actions.
• Review and approve CAPA documentation for completeness and accuracy.
• Escalate quality issues to Sr. Manager, Quality or Quality Director as necessary.
• Train and qualify deviation authors, CAPA and Continuous Improvement (CI) owners and approvers to ensure competency in investigation and documentation processes.
• Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement.
• Prepare and present CAPA metrics and trend reports for management review and regulatory inspections.
• Provide training and guidance to personnel on CAPA processes and best practices.
• Support internal, client, and regulatory audits related to CAPA activities.
• Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions.
• Drive continuous improvement initiatives to strengthen the CAPA system and overall quality performance.

The qualifications:

• Bachelor’s degree required, preferably in a science-related field with a minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master’s degree with 3 years of pharmaceutical or medical device industry experience
• Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
• Proven experience managing CAPA systems and leading investigations.
• Demonstrated ability to analyze and interpret quality data, trend metrics, and identify systemic issues using analytical tools.
• Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus.

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends.
• Position may require sitting or standing for long periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for Automation Engineers (level depends on experience) that are responsible for leading the identification, implementation, optimization, and maintenance of process automation and controls systems in pharmaceutical processing, packaging, and facilities. These engineers ensure efficient, quality, functional, and compliant process automation systems and supports engineering systems, capital projects, technical services, and plant support, as applicable. These positions are 100% onsite at the Bloomington, Indiana facility and reports directly to the Sr. Manager, Automation Engineering.

The responsibilities:

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs
• Specify and configure ins
• Identify and drive improvement opportunities for equipment, instrument, and process optimization, efficiency, and cost reduction through automation technologies and lead initiatives to implement projects
• Lead the deployment of the full system lifecycle for process automation and control systems including the design, assessment, selection, commissioning, validation, and implementation of systems
• Troubleshoot automation and controls systems issues, conduct root causes analysis, and implement corrective actions to minimize downtime and ensure continuous operations
• Conduct risk assessments of automation and controls systems
• Ensure automation and controls systems meet regulatory requirements by conducting and assisting with validation activities

Required qualifications:

• Level I: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) or 6+ years of relevant experience
• Level II: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) or 10+ years of relevant experience
• Level III/Sr: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 6+ years of relevant experience
• Level IV/Principal: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 10+ years of relevant experience
• Level V/Sr. Principal: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 15+ years of relevant experience
• Work experience in process automation and controls systems (including programming PLCs, SCADA, and HMI systems) in pharmaceutical and/or manufacturing environments
• Experience in reading and interpreting electrical schematics and Process & Instrumentation Diagrams (P&IDs)
• Experience in Ignition SCADA/HMI
• Knowledge of coding in Rockwell and Siemens (PLCs and HMIs)
• Knowledge of automation and controls hardware and software systems
• Ability to prioritize projects and workload
• Excellent verbal communication and technical writing skills

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

Schedule:  2pm - 12:30am (Monday- Thursday)

The responsibilities:

• Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
• Lead troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

The work environment:

You’ll work in a fast‑paced, hands‑on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A–D cleanroom spaces, supporting the critical production of high‑quality sterile products.

Required qualifications:

• High school diploma or GED.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
• Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.
• Work in Grade A–D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

 Schedule: 10:00pm-8:30am, Mon-Thurs

The responsibilities:

• Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
• Lead troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

The work environment:

You’ll work in a fast‑paced, hands‑on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A–D cleanroom spaces, supporting the critical production of high‑quality sterile products.

Required qualifications:

• High school diploma or GED.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
• Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.
• Work in Grade A–D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Schedule: Friday-Sunday 7:00pm-7:30am

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance 
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Associate Director of Quality Assurance, is a member of the Quality Assurance Leadership Team reporting directly to the Quality Director. He or she provides leadership and direction for Filling Quality Line Operations and Finishing Quality Line Operations.  The Associate Director provides decision making and oversight to ensure compliance to all standard operating procedures for areas of responsibility. He or she must fully support and drive quality operations, communicate effectively with production team members, multiple levels of management, and other customer support departments. The Associate Director creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations.
• Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
• Creates/Develops a strong team by setting clear direction and empowering members to obtain results that support strategic objectives.
• Develops department annual budget and ensures spending within expected quarterly forecasts.
• Plan, organize, direct, and evaluate applicable activities to ensure the safety and reliability of manufactured products.
• Responsible for ensuring compliance to plant procedures, corporate quality policies, Federal and European regulations, and guidance.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production, and other support functions as necessary to meet plant and department goals/objectives.
• Ensures training compliance for QA team.
• Supports QA oversight of Aseptic Filling operations, Inspection, Labeling and Packaging operations, and Warehouse operations, including finished product reserve sample inspection, finished product sampling, and shipping.
• Participates in escalated client issue resolution (conference calls, client visits, audits).
• Responsible for tracking and trending Quality data for review and reporting.
• Lead teams in continuous improvement project activities.
• Represent Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs.
• Review and Approve deviations and or non-compliance issues that occur during production activities and ensures thorough investigation, root cause analysis, and corrective and preventative action.
• Serve as designee for some reviews and approvals performed by the Quality Director, including Quality Review Board endorsements.
• Responsible for setting strategic direction of department, including coordination of coverage across team to support filling and packaging operations 24/7.

The requirements:

• Bachelor's degree required preference in a Life Science field; advanced degree preferred.
• 12 years of pharmaceutical manufacturing experience required. Preference in quality operations, manufacturing, or technical services
• Minimum 10 years’ experience in a management role.
• In-depth knowledge of FDA Annex One requirements and supporting audits
• Experience with international regulatory bodies preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to qualify for entry into Class A/B aseptic facilities.
• Must wear appropriate personal protective equipment as applicable.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 

This position is required to work all designated plant holidays.

First Shift - 6AM-4:30PM (Monday-Thursday)

The responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.  

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Lifting and carrying up to 70 lbs
• Pushing and pulling up to 35 lbs
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Lifting and carrying up to 37 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                                                                          

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solution

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

 The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching,
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Formulation Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.
• Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                                                                          

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solution

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Hours for this position are Monday-Thursday 2PM-12:30AM (4/10hr days) 

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching,
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                                                                          

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solution

Summary: 

The Formulation & Preparation Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, weighing materials, formulation of product, and conducting in-process testing, filtration,  cleaning and sanitization, sterilization of equipment, batch reconciliation, compliant gowning, setup and operation of parts washer, autoclaves, and tank cleaning in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.  The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor. 

Shift structures:

1: M-Th 7:00 – 16:00

2: M-Th 15:00 – 00:00

3: M-Th  23:00 - 8:00

4: Fr-Su 7:00 – 19:30

5: Fr-Su 19:00 – 7:30

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): 

• Understand and follow current Good Manufacturing Practices (GMP) 

• Understand and follow current Good Documentation Practices (GDP) 

• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.   

• May be required to cross train as a support operator to assist additional manufacturing areas. 

• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches. 

• Perform routine verification of equipment and instruments. 

• Compare Lot numbers to ensure correct components are being used for the specified batch 

• Complete calculations to support preparation and formulation activities 

• Retrieve and test in-process samples 

• Clean, Sterilize, and sample equipment 

• Setup and operate autocalves, parts washers, tank cleaning, and formulation stations in Cleanroom areas.   

• Assist in the training and development of other team members 

• Required to maintain attendance in accordance with the Bloomington Attendance Policy 

• Scheduled weekend overtime may be required  

Job Requirements (Education, Experience and Qualifications): 

• High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred. 

• Must be able to understand, speak, read and write English in order to comply with necessary SOP’s, job-specific training materials, GMP’s, and other manuals. 

• Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.) 

• Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems  

• Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.  Ability to demonstrate proficiency in reading equipment drawings.  Ability to work safely with equipment under pressure. 

Physical / Safety Requirements 

• Must be able to lift and carry up to 70 lbs, and push and pull up to 150 lbs. 

• Extended periods of standing and/or walking 

• Extended periods in Grade A, B, C, D production environments 

• Use of hands and fingers to manipulate equipment is required 

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Schedule: Friday-Sunday 7:00am-7:30pm

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/