Job Description

The Senior Account Manager (SAM) oversees projects within a vertical account team to ensure quality and provide continuity and tactical alignment while also leading high-profile projects from the client through to the project manager and cross-functional team. The SAM will partner with the Account Director to assist brand partners with the development and management of the tactical plan. This role requires a strong awareness of the account’s strategic direction, as well as knowledge of clients’ products and processes. The success of this position relies on the success of the team, meeting clients’ expectations, partnering with Avant colleagues, and individual performance. 

What you’ll do:

• Ensure quality and consistency across multiple tactics that are led by both Avant and   external partners  

• Provide oversight and consultation to Account Managers as it relates to project execution  

• Act as the in-house client at all times by communicating client expectations to the crossfunctional team  

• Act as the Customer Management Office (CMO) liaison within the respective   account (vertical)  

• Provide invoicing information and budget status updates to clients as requested  

• Provide direction and review job scope changes and closeouts as necessary  

• Provide peer-to-peer channel insights and recommendations  

• Drive strategic partnerships with clients by having and applying knowledge of their products and objectives  

• Lead and actively participate in strategic brainstorming sessions and annual   strategic planning  

• Assist the business owner as needed with the following tasks  

• Create proposals for projects within assigned accounts  

• Partner with finance team and project managers in budget development  

• Perform other strategic work as delegated by the Account Director

• Ensure strategic objectives are met with each client project  

• Support organic growth opportunities for the account through a strong understanding of Avant capabilities, client needs, and attention to buying signals  

• Partner successfully with Project Management Team to execute projects from the initiating and planning phases through the closing phase  

• Develop and manage project creative briefs and client scope statements  

• Supervise projects to ensure tactical and strategic goals are met  

• Follow all policies, procedures, industry standards, and compliance guidelines and ensure team members’ adherence  

• Execute client status meetings and prepare all meeting materials and follow-up items (agendas, notes, etc.)  

• Partner successfully with Project Management Team to execute projects from the initiating and planning phases through the closing phase (cont.)  

• Monitor the overall project scope from a client and account perspective and communicate scope changes when necessary   

• Provide final approval on all deliverables to ensure strategic objectives are met

• Develop and communicate status reports with management and the client, monitor project and team results against client expectations   

• Monitor and manage project-related risks and issues in partnership with the project manager; resolve and escalate risks and issues to the client when needed  

 This position is a perfect fit for you if: 

• Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

• You are highly organized self-starter, able to work independently and under tight deadlines. 

• You speak social media: X, Facebook, Instagram, LinkedIn, Snapchat, YouTube, Pinterest, you name it. You have in in-depth knowledge of today’s top social platforms 

What you should have:   

• BA/BS or equivalent required  

• 3-4 years of team leadership experience required  

• 3-4 years of client/customer management experience required  

• 2+ years in pharmaceutical sales/marketing preferred  

• 2+ years’ experience in strategic planning preferred

• Leadership experience in a corporate, marketing, or life sciences environment preferred  

• Project management experience preferred

Pay Range: $85,000-$100,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

Role Overview

The Account-Based Marketing (ABM) Manager is responsible for designing and executing 1:1, 1:few, and 1:many programs that deepen engagement, accelerate pipeline, and drive revenue within a defined set of strategic and high-potential accounts.

Partnering closely with Sales, Revenue Marketing, and cross-functional Marketing teams, this role builds tailored, insight-led programs that reach buying groups across target accounts—spanning developers, technical stakeholders, and executive decision makers.

You are a data-guided, customer-obsessed marketer who enjoys combining strategy with hands-on execution. You’re comfortable working directly with sales leaders, translating account insights into integrated plays, and measuring performance at both the account and program levels.

Key Responsibilities

ABM Strategy & Planning

• Develop and own the ABM strategy for a prioritized list of accounts, aligned to regional and global go-to-market goals
• Segment accounts into 1:1, 1:few, and 1:many motions based on potential, buying stage, and strategic importance
• Partner with Sales leadership and account teams to understand account plans, key initiatives, and decision makers and translate these into ABM plans
• Build annual and quarterly ABM roadmaps, including campaigns, experiences, and executive engagement moments

Campaign & Program Execution

• Plan and execute integrated ABM programs across channels (email, digital, direct mail, events, executive briefings, field experiences, partners, etc.) that are tailored to account needs and buying stages.
• Create or adapt messaging and content by persona and industry, leveraging global assets where possible and developing custom assets where needed.
• Orchestrate multi-touch plays (e.g., outbound sequences, event invitations, executive briefings, workshops) in partnership with Sales, BDRs, and Marketing Operations.
• Coordinate program logistics end-to-end, including audience lists, landing pages, invitations, reminders, follow-up, and handoff to Sales.

Sales Alignment & Collaboration

• Act as a strategic partner to Sales for target accounts, joining regular account reviews and QBRs to align on goals, coverage, and gaps
• Provide Sales with ABM playbooks, one-page program briefs, talk tracks, and follow-up templates to support consistent execution
• Help Sales prioritize next-best actions within accounts (meetings, workshops, briefings, executive programs) based on engagement and intent signals
• Capture and share win stories, best practices, and learnings from ABM programs across regions and sales teams

Data, Insights & Reporting

• Define and track ABM performance metrics, such as engagement across buying groups, opportunity creation, deal acceleration, influenced and sourced pipeline, and revenue
• Partner with Analytics, RevOps, and Marketing Operations to pull and analyze account-level reports from CRM, marketing automation, and BI tools
• Build closed-loop reporting to show impact of ABM programs at the account, segment, and program level; present insights in monthly/quarterly business reviews
• Use data and experimentation to test, learn, and optimize ABM tactics, audiences, and messaging

Technology, Data & Operations

• Leverage ABM and marketing technologies (e.g., CRM, marketing automation, intent platforms, personalization tools, sales engagement platforms) to orchestrate and scale programs
• Maintain clean account lists, segments, and tags in CRM/marketing tools to enable accurate targeting and measurement
• Partner with Operations to document and improve ABM processes, SLAs, and workflows across Marketing and Sales

Qualifications

• 5-7+ years of experience in B2B marketing, account-based marketing, field/regional marketing, demand generation, or a related role; experience in SaaS/technology preferred
• Hands-on experience building and executing ABM programs (1:1, 1:few, or 1:many) in partnership with Sales or Customer Success
• Strong project management and organization skills; able to manage multiple programs, stakeholders, and deadlines in a fast-paced environment
• Comfort working with CRM and marketing tools (e.g., Salesforce, Marketo/Eloqua/HubSpot, ABM/intent platforms, sales engagement tools) and pulling basic performance reports
• Excellent written and verbal communication skills, with the ability to synthesize complex information for Sales, executives, and cross-functional partners
• A data-guided mindset and curiosity to understand what’s driving results and where to iterate

Preferred Experience

• Direct experience running account-based plays for strategic, enterprise, or key growth accounts spanning multiple personas
• Familiarity with developer and technical audiences (e.g., developers, architects, IT decision makers) and how to engage them alongside business stakeholders
• Experience collaborating with Sales Development / BDR teams on outbound and follow-up motions tied to ABM campaigns
• Background working with industry or vertical-focused programs (e.g., financial services, retail, healthcare, public sector)

What Success Looks Like

• ABM programs launch on time, on brief, and on budget, with smooth cross-functional execution
• Clear improvements in engagement across buying groups, opportunity creation, deal velocity, and influenced/sourced pipeline within target accounts
• Strong satisfaction and trust from Sales leadership and account teams, who view ABM as a critical partner in their growth strategy
• High-quality, consistent documentation, reporting, and insights that feed into regional, account, and functional planning cycles

About MongoDB

MongoDB is built for change, empowering our customers and our people to innovate at the speed of the market. We have redefined the database for the AI era, enabling innovators to create, transform, and disrupt industries with software. MongoDB’s unified database platform, the most widely available, globally distributed database on the market, helps organizations modernize legacy workloads, embrace innovation, and unleash AI. Our cloud-native platform, MongoDB Atlas, is the only globally distributed, multi-cloud database and is available across AWS, Google Cloud, and Microsoft Azure.

With offices worldwide and over 60,000 customers, including 75% of the Fortune 100 and AI-native startups, relying on MongoDB for their most important applications, we’re powering the next era of software.

Our compass at MongoDB is our Leadership Commitment, guiding how and why we make decisions, show up for each other, and win. It’s what makes us MongoDB. 

To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From employee affinity groups, to fertility assistance and a generous parental leave policy, we value our employees’ wellbeing and want to support them along every step of their professional and personal journeys. Learn more about what it’s like to work at MongoDB, and help us make an impact on the world!

MongoDB is committed to providing any necessary accommodations for individuals with disabilities within our application and interview process. To request an accommodation due to a disability, please inform your recruiter.

MongoDB, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type and makes all hiring decisions without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

REQ ID: 1273383120

ABOUT THE POSITION, Playworks Indiana is seeking a Development Manager who reports directly to and works in close partnership with the Executive Director to execute the organization’s fund development strategy. The Executive Director sets strategic direction, priorities, and key relationships, and this role is responsible for driving execution, coordination, and follow-through across all development efforts.

This role oversees development operations, stewardship coordination, event execution, Salesforce management, and day-to-day relationship support, while managing defined fundraising goals tied to events, sponsorships, and partner renewals. The role also supports individual giving efforts as part of the broader fundraising mix, in alignment with regional priorities.

The Development Manager is a highly collaborative, detail-oriented role focused on strong execution, follow-through, and coordination in support of organizational strategy, narrative, and relationships. While this role collaborates closely with the Playworks HQ Development team through shared planning and aligned initiatives, all regional work is directed by and accountable to the Executive Director.

Here’s where you come in:

Specifically, you will have Program Implementation, Coaching, and School Partnership duties as follows-

Key Areas of Responsibility

Fund Development & Stewardship  - 30%

• Manage a defined portfolio of corporate, foundation, and individual partners, in alignment with Executive Director priorities, with a focus on renewals, stewardship, and growth; be accountable for fundraising goals tied to events, sponsorships, and partner renewals.
• Implement corporate sponsorships and engagement opportunities across Playworks Indiana initiatives, leading early cultivation and advancement of next steps.
• Support relationship-building with foundation partners through ongoing engagement and positioning for future funding opportunities.
• Owns grants coordination and proposal support, including maintaining the grants calendar, researching new opportunities, coordinating submissions and reporting, and ensuring alignment with organizational voice.

Events & Partner Engagement - 30%

• Plan and execute core fundraising and engagement events, including logistics, vendors, sponsorship fulfillment, volunteer coordination, and partner engagement activities.
• Manage event budgets in partnership with the Executive Director, ensuring expenses are tracked and events remain within approved budgets.
• Oversee event-related communications and follow-up, including materials, run-of-show development, and post-event stewardship.

Governance & Leadership Support - 15%

• Coordinate logistics and materials for board and committee meetings, including scheduling, preparation, and follow-up, under the direction of the Executive Director.
• Capture and maintain clear records of decisions and action items from board, committee, and leadership meetings.

Development Operations & Salesforce - 15%

• Own Salesforce and development systems, ensuring accurate data, effective workflows, and reliable reporting.
• Track grants, deliverables, and reporting requirements, coordinating internal timelines and follow-through.
• Prepare development reports and maintain fundraising calendars, deadlines, and follow-through for leadership.

Visibility, Communications & Reporting Support - 10%

• Manage development-related communications, including social media posts, partner acknowledgments, event highlights, and newsletter content.
• Coordinate with marketing, digital, and program teams to develop content and assets that support fundraising, stewardship, and partner engagement.
• Oversee preparation of development-related reports and materials, including grant reports, partner reports, the annual report, and development-focused newsletters.

Responsibilities may evolve over time based on organizational needs and priorities.

Required Skills & Experience

• 4–6 years of experience in development, fundraising operations, account management, or related nonprofit roles.
• Demonstrated experience managing donor relationships, events, and revenue goals.
• Strong organizational and project management skills; able to manage multiple timelines and priorities simultaneously.
• Experience with Salesforce or comparable CRM systems; comfort with data, reporting, and systems.
• Clear, professional written and verbal communication skills; ability to edit and tailor content to organizational voice.
• Strong interpersonal skills and comfort representing the organization in meetings, events, and site visits.
• Ability to work collaboratively in a highly engaged, fast-moving environment.
• Knowledge of local business, civic, or philanthropic communities preferred.
• Willingness to attend occasional evening or weekend events and travel locally as needed.

Compensation & Benefits:

Playworks offers the full package - great benefits, a fun place to work and an opportunity to grow professionally.

• This is a full-time, salaried, exempt position based in Indiana and reporting to the Executive Director
• At Playworks, our starting salary takes into consideration internal pay scales, geographic pay differential, and robust external market data. We highly value transparency in compensation and are therefore committed to adhering to established compensation pay points. The starting salary for this position is $60,900.
• A comprehensive benefits package, including medical, dental, vision, disability, 401(k) plans with employer match of up to 1% of salary, life insurance, employee-funded pre-tax health, and child care spending accounts.
• Generous Flex PTO policy, paid sick and holiday leave

This is a hands-on, creative, playful, and fun-loving place to work, all while contributing to the success of our nation’s youth. So if you're ready to immerse yourself in the education sector, working on a rewarding set of challenges, and if you've got the skills, experience, passion, and a team spirit, apply!

Please include:

• A cover letter describing your interest in Playworks and how your experience has prepared you for this role.
• Resume.
• References will be requested.

ABOUT PLAYWORKS: At Playworks, we believe in the power of play to bring out the best in every kid. We create a place for every kid on the playground to get active, build valuable skills, connect, and have fun. We partner with schools, districts, and after-school programs to provide a service or mix of services, including on-site coaches, professional training for school staff who support recess, and consultative partnerships. 

As an equal opportunity program, Playworks encourages applications from all individuals regardless of age, gender, gender identity/expression, race, ethnicity, sexual orientation, religion, faith, marital status, physical ability, or any other legally protected basis. Playworks evaluates all candidates for employment, volunteering opportunities, or board service on a merit basis.

About the Position
Clinical Architecture is seeking a Client Success Manager in the Indianapolis, IN area to create a positive experience for our clients as they integrate our software products. The primary objective of this role is to gain an in-depth understanding of our clients’ business needs and collaborate to ensure those needs are met through on-boarding, software implementation, and training. This position will challenge you to learn about our software and its capabilities and assist our clients with their initiatives. We strive to build long-term relationships with our clients, and we want to respond to their needs as our partnerships grow.

• This role is based on-site at our Carmel, IN Headquarters, five days a week. While we are an in-office organization, we do our best to offer flexibility when needed, ensuring both work-life balance and uninterrupted business operations.
• Applicants must be authorized to work in the U.S. without sponsorship.  
• Providing false information on application questions may result in automatic dismissal of your application. Please answer questions truthfully and to the best of your ability.

Responsibilities

• Provide a positive client experience by delivering great service and engaging with clients throughout our business relationship.
• Ability to understand clients’ needs and use all available resources to identify options and recommend alternatives.
• Collaborate closely with the Sales team to support renewals and identify expansion opportunities.
• Must maintain a working knowledge of assigned clients, our software, and be able to respond to inquiries efficiently and accurately.
• Effectively demo our software capabilities including addressing use-cases, implementing best practices, and identifying system integration opportunities.

Qualifications

• 4+ years of proven customer relationship management experience is required.
• Proven ability to translate between IT and Business stakeholders to ensure goals are achieved is required.
• 3+ years of experience in federal contracting and / or account management is preferred.
• 3+ years experience in healthcare technology and / or healthcare terminology (e.g., SNOMED, LOINC, CPT, ICD-10-CM) is preferred.
• Experience in related fields (e.g., Business, Informatics, Public Health, Healthcare Policy & Administration) is preferred.
• Proficiency with MS Word, MS Excel, MS PowerPoint, and familiarity with Hubspot is preferred.
• Previous project management, project coordination, or project administration experience is preferred.
• Good communication is essential, both verbally and via email.
• Highly motivated to learn new skills.
• Ability to multi-task, prioritize, and manage time effectively.

***Unfortunately, the Client Services Business Analyst I - Healthcare Data is not able to provide sponsorship now or anytime in the future.***

***This role requires you to be located in the Indianapolis area because this is a hybrid role and requires one a day a week in the office.***

Position Summary: 

The Client Services Analyst will play a critical role in ensuring the successful delivery of services and solutions to our clients.  This position requires a high level of technical expertise along with strong communication skills and a commitment to excellence.  This role will support several clients with oversight from a manager of client services. The ideal candidate will have a strong sense of ownership and accountability, an inquisitive mindset, a background in T-SQL, and the ability to consistently produce high-quality work in a timely manner following a standard process. 

Essential functions of the job include but are not limited to:  

• Analyze client requirements and translate them into technical specifications. 
• Ensure the accuracy and integrity of data by conducting thorough quality checks and validations. 
• Own client jobs making sure they are running smoothly and on-time per established calendar; identify and remediate pain points to continually improve the process. 
• Collaborate with cross-functional teams to deliver value to our clients every day. 
• Maintain clear and effective communication with clients, address issues promptly, and provide regular updates. 
• Respond to and fulfill client tickets and requests in a timely manner with quality. 
• Contribute to client team meetings for client projects and engagements. 
• Take accountability for project deliverables, ensuring they meet the established standards and client expectations. 
• Develop, test, and deploy T-SQL scripts to support various client projects. 
• Implement advanced ETL processes to acquire and load large datasets. 
• Follow established procedures and standards as outlined by leadership. 
• Maintain associated procedural documentation. 
• Evaluate appropriateness of data for ad hoc requests and client projects. 
• Contribute code that is well-documented, logical, and easy to follow. 
• Other duties as assigned. 

Qualifications: 

Minimum Required: 

• Undergraduate degree 
• Experience with relational databases 

Preferred:  

• 1 to 3 years industry experience in either data analytics or healthcare 
• Evident proficiency and hands-on experience using T-SQL in a Microsoft SQL Server environment. 
• Descriptive statistics and/or Pharmaceutical/Healthcare industry experience. 
• Undergraduate degree with a quantitative focus. 

Skills:  

• Excellent communication skills, both written and verbal, with the ability to convey technical information to non-technical stakeholders. 
• Strong sense of accountability and ownership for delivering high-quality work. 
• Exceptional attention to detail, ensuring accuracy and precision in all tasks. 
• Proficiency in T-SQL with hands-on experience in writing complex queries and scripts. 
• Effective time management skills and ability to keep multiple projects on schedule. 
• Experience in a client-facing role or in the pharmaceutical industry is a plus 
• Ability to work remotely. 
• Strong problem-solving skills and a proactive approach to identifying and addressing issues within established product boundaries. 
• Strong team player with the ability to work and execute independently. 
• Desire for continuous improvement and growth – driven to excel. 
• Demonstrated proficiency in Microsoft Office product suite including PowerPoint, Word, and Excel. 
• Experience in SSIS is a plus but not required. 

#LI-Remote

Multi-site Dermatology Group Seeks Practice Manager

Optima Dermatology is recruiting a high energy leader to join our Indiana Skin Cancer Center location in Greenwood, IN.

Position Details:

The Practice Manager is responsible for day‐to‐day operations and patient experience of the local dermatology clinic. Coordinates and supervises entire operation. Assists the company in reaching goals and objectives related to the dermatology clinic’s clinical and financial performance.

Responsibilities:

• Implement and enforce policies and procedures for the clinic.
• Identify and resolve patient satisfaction and patient flow/throughput issues.
• Participate in the recruitment, training, and orientation of new employees.
• Select, train, supervise, and monitor quality and production levels of site staff.
• Develop monthly staff schedule and assist with timecard approval as needed.
• Ensures cash deposits are properly tracked and deposited.
• Conduct performance evaluations.
• Facilitate all clinical site meetings.
• Monitor inventory and ordering of office supplies, medical supplies, and equipment.
• Interact with patients, review patient feedback, and address patient service issues.
• Develop and implement programs to monitor and improve patient satisfaction.
• Attend community marketing events in accordance with marketing department requirements.
• Ensure compliance with all Company directives to include patient privacy initiatives as well as employee safety.
• Audit records to ensure compliance with company policies and procedures.
• Prepare weekly and monthly operational dashboards and participate in weekly calls with all Practice Managers to review performance dashboards.
• Ensure compliance with Federal and State employment regulations, OSHA, HHS and labor laws as directed by the human resources department.
• Facilitate and attend all facility audits and inspections as applicable.
• Conduct special project and studies as assigned by senior management.
• Work with all clinic staff to promote teamwork and help ensure a positive and productive work environment.
• Assure clinic is open and appropriately staffed during regularly scheduled hours and special events and that all facilities and equipment are available, operational, safe, and clean.
• Coordinate facility and equipment maintenance and other vendor services.
• Perform front‐end registration and/or clinical tasks as a back‐up in case of absence or high demand.

Qualifications:

• Bachelor’s Degree, preferred
• Five years of experience in management, preferred.
• Ability to supervise, train, and evaluate new and current staff.
• Familiarity with medical billing systems, basic medical coding, and basic medical terminology.
• Demonstrated skills in medical practice management, human resources, and data analysis.
• Ability to establish and maintain a positive relationship with peers and subordinates.
• Ability to accomplish required tasks without supervision.
• Superior verbal and written communication skills.
• Ability to utilize software, spreadsheets, and word processors.

Compensation

The position will offer competitive compensation. In addition, it will offer the personal reward associated with transforming our patients’ lives and building the most defensible healthcare services platform in the country.

Benefits

Our benefits include generous health, dental, vision, disability, and life insurance.

About Optima Dermatology

At Optima Dermatology, our mission to revolutionize skin care is made possible by our world class team that is highly engaged, mission-driven, and inspired to set the new standard in dermatology. We are growing rapidly and looking for key team members who believe in our mission and want to make a difference in the lives of our patients. We foster a collaborative environment that is fun and hardworking and promise you will work alongside amazing colleagues you are proud to call your teammates.

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.

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/

FIELD SERVICE TECHNICIAN – Level 1, 2 or 3

Purpose of Position:

IEM will provide training on our specific equipment and commissioning process in Ashburn, VA for approximately 4 weeks. You will be responsible for hands-on field service work at customer sites, with a focus on installation of components and subassemblies, and basic commissioning of IEM equipment primarily in data center or industrial applications. This includes, but may not be limited to:

• Attending project meetings as required, including coordination with contractors and clients.
• Installation and modification of electrical or mechanical components and subassemblies which may include: Panelboard interiors, Circuit breakers, Bus bar, Switchgear section doors and subpanels, addition of control components, Power Cabling and control wiring;
• Perform basic testing of modified assemblies (visual, ductor, etc.).
• Perform basic commissioning of switchboards, controls panels, and power products.
• Troubleshooting of electrical circuits and networking equipment.
• Coordinating with Technical Project Manager or manufacturing facilities to find solutions to product or commissioning issues identified by IEM or reported by the customer in the field, and identifying additional field resources needed for installation and replacement parts.
• Performing preventive maintenance, field installations and modifications to existing equipment
• Technical product support

Education and Experience:

• A technical degree or equivalent and 8 yrs+ of experience working in a manufacturing environment, data center or field service role with COMMISSIONING OF LV/MV ELECTRICAL SWITCHGEAR (required for Level 3 candidates).
• Must be a team player and have strong communication skills
• Ability to work independently without direct supervision is a must
• Ability to travel (75%). Must be willing to work evenings and weekends when needed.

• Experience with switchgear and electrical controls system. (required for Level 3)
• Military experience (Plus)
• Ability to read and interpret electrical wiring diagrams (required for level 3)

Compensation

The hourly range for this role is $36.30 -$52.80 per hour, based on location, experience, and qualifications.

At Greenlight Guru, we help the world’s most innovative medical device companies bring high-quality, life-changing products to market faster. We serve 1000+ global customers with our quality management and clinical data capture software, helping them get their products on the market and keep them there. 

When you join the team at Greenlight Guru, you’ll be a part of a collaborative, mission-driven team working in one of the most exciting and rewarding industries on the planet. Backed by JMI Equity, one of the premier growth equity firms for SaaS companies, Greenlight Guru is growing—and looking for individuals who are difference makers. Is that you?

Greenlight Guru is looking for a highly motivated, collaborative, and results-oriented relationship builder with the thirst to be in a fast-paced and high-growth environment. The Partner Manager will be responsible for driving the overall growth and success of the Greenlight Guru Partner ecosystem. You are a self-starter with high standards and attention to detail, and have the ability to prioritize and respond to the needs of the partner ecosystem. 

The position spans a range of go-to-market initiatives and partnering motions in managing partner relationships to drive business flow to Greenlight Guru. This role requires a “can-do” mentality with the desire to learn, and a thirst for innovation to drive growth. Serving as an integral player in our partner organization, the position reports to the Chief Sales Officer (CSO).

Responsibilities:

1. Partner Sourcing (Find)

• Identify and prioritize target partners (consultants, system integrators, tech partners, etc.)
• Research markets, ecosystems, and competitor partnerships
• Build and manage a pipeline of prospective partners
• Conduct outreach and initial qualification conversations

1. Partner Acquisition (Sign)

• Lead partnership discussions and negotiate agreements
• Define joint value propositions and business cases
• Align on go-to-market (GTM) strategies
• Work with legal, finance, and leadership to finalize contracts

1. Partner Development (Grow)

• Onboard new partners (training, certifications, enablement)
• Co-develop marketing and sales plans
• Drive pipeline and revenue through partners
• Monitor partner performance (KPIs, revenue targets, engagement)
• Maintain ongoing relationships and act as the primary point of contact

 Requirements:

• 3-5 years of experience in a business development or partner management role, working with partner motions including referral, co-sell, reseller, and services arrangements
• A successful track record of developing partner lead pipeline through business development
• Strong project management, time management and organizational skills, with the ability to manage multiple relationships while driving desired metrics
• Passion for learning and solving problems to deliver solutions, with a positive outlook
• Demonstrable success in a collaborative, fast-paced environment
• Strong skills in Salesforce CRM, Google Docs
• Willing and able to work remotely and travel as required (approximately 10%)
• Experience in MedTech a plus

Benefits:

• Co-workers who care deeply about our mission to spur medical device innovation
• Flexible hours
• Work from home options
• Unlimited PTO
• Health insurance (vision, medical, dental)
• Disability insurance
• 401k

The base salary range for this role is $85,000 - $100,000.  Actual base salary is determined by factors such as, but not limited to, experience, education, skills, and geographic location. In addition, there will be a variable plan based on partner success that can add $25K+ to the OTE.

Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.  If you need assistance or accommodations to submit your application for this position, please email careers@greenlight.guru.

Responsibilities

• Develop and operationalize GTM strategy for efficient new market penetration
• Create, build, and manage relationships with referral sources across priority markets
• Go in the field 4 - 5 days/week to lead meetings with patients, parents, and providers to uncover needs, address barriers to treatment, and cement community partnerships
• Design strategies to better support and engage referral partners across different channels
• Deepen Charlie Health’s penetration across existing partnerships
• Attend and lead various educational meetings, marketing presentations, and networking events both in person and via conference call
• Synthesize and share market feedback from partners, patients, and stakeholders to inform go-forward marketing and product strategies
• Work closely with internal partners including marketing, product, client success, and legal to deliver on GTM goals

Requirements

• Must be based in the Bloomington, IN area
• Must be fluent in English 
• You have 1-4 years proven sales experience - owning & overachieving KPIs is a plus
• Experience working with or selling to healthcare organizations a plus
• Ability to travel locally with reliable transportation & valid drivers license (within ~1 hour driving distance) 4-5 days/week for meetings with potential referral partners 
• Ability to energize, advise & persuade senior corporate personnel 
• Strong interpersonal, relationship-building and listening skills, with a natural, consultative style
• Strong project management skills, with a demonstrable ability to corral and manage details in a fast-paced, fluid environment
• Experience with Microsoft Office, Salesforce & Zoom is a plus

Benefits

Charlie Health is pleased to offer comprehensive benefits to all full-time, exempt employees. Read more about our benefits here. 

Additional Information

The total target base compensation for this role will be between $65,000 and $80,000 per year at the commencement of employment. In addition to base compensation, this role offers a target performance-based bonus. Please note, pay will be determined on an individualized basis and will be impacted by location, experience, expertise, internal pay equity, and other relevant business considerations. #LI-HYBRID

Responsibilities

• Develop and operationalize GTM strategy for efficient new market penetration
• Create, build, and manage relationships with referral sources across priority markets
• Go in the field 4 - 5 days/week to lead meetings with patients, parents, and providers to uncover needs, address barriers to treatment, and cement community partnerships
• Design strategies to better support and engage referral partners across different channels
• Deepen Charlie Health’s penetration across existing partnerships
• Attend and lead various educational meetings, marketing presentations, and networking events both in person and via conference call
• Synthesize and share market feedback from partners, patients, and stakeholders to inform go-forward marketing and product strategies
• Work closely with internal partners including marketing, product, client success, and legal to deliver on GTM goals

Requirements

• Must be based in the Lafayette, IN area
• Must be fluent in English 
• You have 1-4 years proven sales experience - owning & overachieving KPIs is a plus
• Experience working with or selling to healthcare organizations a plus
• Ability to travel locally with reliable transportation & valid drivers license (within ~1 hour driving distance) 4-5 days/week for meetings with potential referral partners 
• Ability to energize, advise & persuade senior corporate personnel 
• Strong interpersonal, relationship-building and listening skills, with a natural, consultative style
• Strong project management skills, with a demonstrable ability to corral and manage details in a fast-paced, fluid environment
• Experience with Microsoft Office, Salesforce & Zoom is a plus

Benefits

Charlie Health is pleased to offer comprehensive benefits to all full-time, exempt employees. Read more about our benefits here. 

Additional Information

The total target base compensation for this role will be between $65,000 and $80,000 per year at the commencement of employment. In addition to base compensation, this role offers a target performance-based bonus. Please note, pay will be determined on an individualized basis and will be impacted by location, experience, expertise, internal pay equity, and other relevant business considerations. #LI-HYBRID

Responsibilities

• Develop and operationalize GTM strategy for efficient new market penetration
• Create, build, and manage relationships with referral sources across priority markets
• Go in the field 4 - 5 days/week to lead meetings with patients, parents, and providers to uncover needs, address barriers to treatment, and cement community partnerships
• Design strategies to better support and engage referral partners across different channels
• Deepen Charlie Health’s penetration across existing partnerships
• Attend and lead various educational meetings, marketing presentations, and networking events both in person and via conference call
• Synthesize and share market feedback from partners, patients, and stakeholders to inform go-forward marketing and product strategies
• Work closely with internal partners including marketing, product, client success, and legal to deliver on GTM goals

Requirements

• Must be based in the South Bend, IN area
• Must be fluent in English 
• You have 1-4 years proven sales experience - owning & overachieving KPIs is a plus
• Experience working with or selling to healthcare organizations a plus
• Ability to travel locally with reliable transportation & valid drivers license (within ~1 hour driving distance) 4-5 days/week for meetings with potential referral partners 
• Ability to energize, advise & persuade senior corporate personnel 
• Strong interpersonal, relationship-building and listening skills, with a natural, consultative style
• Strong project management skills, with a demonstrable ability to corral and manage details in a fast-paced, fluid environment
• Experience with Microsoft Office, Salesforce & Zoom is a plus

Benefits

Charlie Health is pleased to offer comprehensive benefits to all full-time, exempt employees. Read more about our benefits here. 

Additional Information

The total target base compensation for this role will be between $65,000 and $80,000 per year at the commencement of employment. In addition to base compensation, this role offers a target performance-based bonus. Please note, pay will be determined on an individualized basis and will be impacted by location, experience, expertise, internal pay equity, and other relevant business considerations. #LI-HYBRID

Responsibilities

• Develop and operationalize GTM strategy for efficient new market penetration
• Create, build, and manage relationships with referral sources across priority markets
• Go in the field 4 - 5 days/week to lead meetings with patients, parents, and providers to uncover needs, address barriers to treatment, and cement community partnerships
• Design strategies to better support and engage referral partners across different channels
• Deepen Charlie Health’s penetration across existing partnerships
• Attend and lead various educational meetings, marketing presentations, and networking events both in person and via conference call
• Synthesize and share market feedback from partners, patients, and stakeholders to inform go-forward marketing and product strategies
• Work closely with internal partners including marketing, product, client success, and legal to deliver on GTM goals

Requirements

• Must be based in the South Bend, IN area
• Must be fluent in English 
• You have 1-4 years proven sales experience - owning & overachieving KPIs is a plus
• Experience working with or selling to healthcare organizations a plus
• Ability to travel locally with reliable transportation & valid drivers license (within ~1 hour driving distance) 4-5 days/week for meetings with potential referral partners 
• Ability to energize, advise & persuade senior corporate personnel 
• Strong interpersonal, relationship-building and listening skills, with a natural, consultative style
• Strong project management skills, with a demonstrable ability to corral and manage details in a fast-paced, fluid environment
• Experience with Microsoft Office, Salesforce & Zoom is a plus

Benefits

Charlie Health is pleased to offer comprehensive benefits to all full-time, exempt employees. Read more about our benefits here. 

Additional Information

The total target base compensation for this role will be between $65,000 and $80,000 per year at the commencement of employment. In addition to base compensation, this role offers a target performance-based bonus. Please note, pay will be determined on an individualized basis and will be impacted by location, experience, expertise, internal pay equity, and other relevant business considerations. #LI-HYBRID

Responsibilities

• Develop and operationalize GTM strategy for efficient new market penetration
• Create, build, and manage relationships with referral sources across priority markets
• Go in the field 4 - 5 days/week to lead meetings with patients, parents, and providers to uncover needs, address barriers to treatment, and cement community partnerships
• Design strategies to better support and engage referral partners across different channels
• Deepen Charlie Health’s penetration across existing partnerships
• Attend and lead various educational meetings, marketing presentations, and networking events both in person and via conference call
• Synthesize and share market feedback from partners, patients, and stakeholders to inform go-forward marketing and product strategies
• Work closely with internal partners including marketing, product, client success, and legal to deliver on GTM goals

Requirements

• Must be based in the Lafayette, IN area
• Must be fluent in English 
• You have 1-4 years proven sales experience - owning & overachieving KPIs is a plus
• Experience working with or selling to healthcare organizations a plus
• Ability to travel locally with reliable transportation & valid drivers license (within ~1 hour driving distance) 4-5 days/week for meetings with potential referral partners 
• Ability to energize, advise & persuade senior corporate personnel 
• Strong interpersonal, relationship-building and listening skills, with a natural, consultative style
• Strong project management skills, with a demonstrable ability to corral and manage details in a fast-paced, fluid environment
• Experience with Microsoft Office, Salesforce & Zoom is a plus

Benefits

Charlie Health is pleased to offer comprehensive benefits to all full-time, exempt employees. Read more about our benefits here. 

Additional Information

The total target base compensation for this role will be between $65,000 and $80,000 per year at the commencement of employment. In addition to base compensation, this role offers a target performance-based bonus. Please note, pay will be determined on an individualized basis and will be impacted by location, experience, expertise, internal pay equity, and other relevant business considerations. #LI-HYBRID

Responsibilities

• Develop and operationalize GTM strategy for efficient new market penetration
• Create, build, and manage relationships with referral sources across priority markets
• Go in the field 4 - 5 days/week to lead meetings with patients, parents, and providers to uncover needs, address barriers to treatment, and cement community partnerships
• Design strategies to better support and engage referral partners across different channels
• Deepen Charlie Health’s penetration across existing partnerships
• Attend and lead various educational meetings, marketing presentations, and networking events both in person and via conference call
• Synthesize and share market feedback from partners, patients, and stakeholders to inform go-forward marketing and product strategies
• Work closely with internal partners including marketing, product, client success, and legal to deliver on GTM goals

Requirements

• Must be based in the Bloomington, IN area
• Must be fluent in English 
• You have 1-4 years proven sales experience - owning & overachieving KPIs is a plus
• Experience working with or selling to healthcare organizations a plus
• Ability to travel locally with reliable transportation & valid drivers license (within ~1 hour driving distance) 4-5 days/week for meetings with potential referral partners 
• Ability to energize, advise & persuade senior corporate personnel 
• Strong interpersonal, relationship-building and listening skills, with a natural, consultative style
• Strong project management skills, with a demonstrable ability to corral and manage details in a fast-paced, fluid environment
• Experience with Microsoft Office, Salesforce & Zoom is a plus

Benefits

Charlie Health is pleased to offer comprehensive benefits to all full-time, exempt employees. Read more about our benefits here. 

Additional Information

The total target base compensation for this role will be between $65,000 and $80,000 per year at the commencement of employment. In addition to base compensation, this role offers a target performance-based bonus. Please note, pay will be determined on an individualized basis and will be impacted by location, experience, expertise, internal pay equity, and other relevant business considerations. #LI-HYBRID

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement.  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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Validation Associate II is a key member of the Computer Systems Validation team within the Technical Services organization. The Validation Associate II must have a working knowledge of the overall requirements dictated by worldwide regulatory agencies with respect to computer systems validation. This position works directly with the Information Technology department and other functional areas and is considered the lead validation resource. The Validation Associate II understands industry best practices and maintains a state of audit readiness always. This position reports to the Manager, Computer Systems Validation.

What you'll be doing:

• Validation document author/reviewer – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates
• Technical writing proficiency – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates.
• Entitlement Reviews – Coordinates user access reviews for recertification and authorization
• Local Change Control owner
• CSV periodic reviews – to maintain the validated state, the Associate will perform periodic reviews of validation packages per established procedures
• Validation lead GAMP Category 1 - 4
• Client audits – The Associate will participate in client audits, responding verbally to auditor’s questions.
• Global Change Control task owner
• System assessments – Quality, Regulatory, Risk, Gap CAPA owner
• NCR/SNCR investigator
• Validation Lead for implementation of major and minor software applications or modules for Good Manufacturing Practices (GMP) use
• Completes detailed risk assessment and 21 CFR part 11 Gap analysis
• Maintains departmental compliance with regulations and corporate procedures
• Coordinates computer systems implementation activities with Vendors and other non-BPS resources
• Creates/Reviews validation documentation, templates, procedures, and all documentation generated during a computer systems validation project
• Participates in Internal/Client/Corporate Audits
• Represents validation department as validation expert in cross-functional work teams
• Advocates and understands best practices for system validations and processes
• Articulates complex systems and communicates to technical and non­technical management

 
What you'll bring:

• BS in Electronic or Software Engineering, Information Systems, or a related field, preferred
• 3+ years experience of working within a regulated environment (worldwide regulatory agencies), particularly in computer systems validation or other validation discipline
• Ability to use enterprise software (i.e., ERP, EDMS, QMS, JDE, Trackwise, etc.)
• Experience with Microsoft Project
• Technical writing skills

Physical / Safety Requirements

• 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
• 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 Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

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
  • Short and Long-Term Disability 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
  • 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 12/31/24

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.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

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

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-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 Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.

The responsibilities:

• Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
• Review and release commercial batch records to production for execution
• Train manufacturing personnel on new and/or significant changes to MBRs
• Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)
• Authors technical studies in support of investigations or process improvements
• Own change controls and associated tasks
• Approve project related Bill of Materials
• Commercial contact for assigned internal and external clients
• Manages client project updates and reviews with all levels of management
• Participate (with assistance) in Business Review Meetings
• Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information
• Participate on client calls and on-site visits to discuss projects and issue resolutions
• Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
• Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria
• Use knowledge of manufacturing systems and equipment to write batch record and perform other duties
• Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product

Required qualifications:

• BS degree, preferably in a science-related field
• Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
• Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
• Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
• Ability to use enterprise software (i.e., JDE, Trackwise, etc.)
• Ability to qualify for Grade C areas

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long periods of time
• Ability to qualify for Grade C areas

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 Packaging Validation Associate I supports all aspects of the packaging process. This includes packaging development, equipment validation and general finishing operations. The position supports Packaging Development including the defining of packaging requirements, materials selection, package design, prototype development, package testing and the development of all related packaging documentation. It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support. This position reports to the Manager, Packaging Validation. 

The responsibilities:

• Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
• Develops and executes Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc.
• Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
• Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders.
• Formulates and recommends validation procedures and technical work in accordance with project and business objectives
• Participates in client and regulatory audits
• Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications
• Acts as Change Control Management (CCM) Owner, Non-Conformance and OCR (Out of Control Report) author
• Identifies and implements changes to Automated Inspection Machines
• Reviews and approves Packaging Technical Services documents

  Desired qualifications:

• Bachelor’s degree in science or engineering related area is preferred or a minimum of 5 years manufacturing experience with 2 years of leadership experience required.
• In-depth process knowledge of related manufacturing equipment and process preferred
• Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
• Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.
• Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.)
• Manages time effectively and independently within assigned responsibilities
• Ability to prioritize multiple projects/workflows and manage time efficiently in order to meet established timelines
• Operates as a self-starter having the ability to complete tasks with minimal direction from manager
• Exhibits a sense of urgency to meet timelines and key milestones
• Possesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing ones

  Physical / Safety Requirements:       

• Must be able to lift up to 25 lbs.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting/standing for long hours, but may involve walking or standing for periods of time
• Must wear appropriate Personal Protective Equipment as applicable
• Must fully understand company safety rules and regulations

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 Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in manufacturing of sterile injectable drug products.

Hours: Monday - Thursday 3:00pm- 12:00am

The Supervisor, Aseptic Operations provides decision making and oversight to ensure compliance to all standard operating procedures and batch records.  They must communicate effectively with Operations support departments (Quality, Technical Services, Engineering & Maintenance, etc.), multiple levels of management, and other customer support departments. The Supervisor, Aseptic Operations builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Understand, follow, coach, and lead their teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
• Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities in order to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
• Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
• Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
• Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operational efficiency and quality. Implement changes as needed based on assessments.
• Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
• Resolve technical, material and cGMP problems that may impact project deadlines.
• Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.

Desirable qualifications:

• Bachelor's Degree in a science, engineering, or business discipline strongly preferred
• High School diploma or GED required
• Minimum 2 years of manufacturing or operations support experience required
• Minimum 1 year leadership experience required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  Microsoft Dynamics, Veeva, PowerBI, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand or sit for extended periods of time
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects (i.e.: tanks, carts, pallet jacks, etc.)
• Must be able to perform overhead work (i.e.: sanitizing walls and ceilings)
• Physical coordination/flexibility to allow gowning for clean room environments
• Use 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
• Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)

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/

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement.  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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Principal Technical Transfer Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.

What you'll be doing:

• Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
  • Serve as the lead technical expert among a cross functional team
  • Lead the cross functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record]
  • Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
• Conduct Non-Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of fill volume dosing qualifications (FVOQ)
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs]
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• SOP owner & process SME
• Perform filter troubleshooting
• Develops and presents in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services and helps with training and on-boarding
   

What you'll bring:

• BS degree required (preferably in a science or engineering related field
• 6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
• Requires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Experience in aseptic processing, sterile filtration, and process validation
• MS Office Suite advanced proficiency
• Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.)

Physical / Safety Requirements:

• Require overtime work on occasion, 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
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

#LI-SB1

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.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

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

This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Sr. Manager, Technical Services, and is 100% onsite at the Bloomington, Indiana facility.

The responsibilities:

• Supports the process validation program.
• Develops and writes process validation procedures.
• Monitors regulatory and industry validation practices to assess our compliance.
• Interacts with the client and client team to define process validation scope.
• Designs and executes the appropriate development Technical Studies to define process parameters.
• Uses statistical tools to design and analyze technical study data.
• Creates a risk assessment of the process to be validated.
• Creates process validation protocols.
• Conducts or coordinates process validation execution for new and existing products.
• Prepares validation summaries.
• Uses statistical tools to analyze process validation data.
• Performs annual reviews / continued process verification (CPV) of validation projects.
• Investigates and executes validation related Corrective and Preventive Actions.
• NCR investigation owner for process validation related, as needed
• Creates and maintains visual controls for Process Validation group
• Serves as Subject Matter Expert (SME) for process validation.
• Independently Participates in regulatory, client and internal audits and a product/process Subject Matter Expert (SME)Develop Industry knowledge, project proficiency, and be able to work independently
• Must be able to identify opportunities for optimization of processes within the department
• Proficiently uses statistical tools to design and analyze technical study data.

Desirable qualifications:

• Bachelor’s degree required, preferably in a science or engineering-related field.
• Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.).
• Ability to communicate effectively at all levels.
• Sound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.

Physical / Safety Requirements:

• May require overtime work, including nights and weekends
• Sitting for long hours and walking/standing for long periods of time
• Must be able to gown for Grade C area

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
  • Short and Long-Term Disability 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
  • 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 12/31/25

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 Project Manager, New Business acts as the primary leader for new business opportunities and client transfer activities.  This role leads projects through process development, validation, and commercialization activities by ensuring that all milestone requirements are delivered per agreed upon project specifications while balancing cost, resource and time commitments. They set appropriate customer and client team member expectations through the use of Project Management tools and guidelines while ensuring effective communications are achieved with all team members. The Project Manager ensures achievement of project objectives for assigned customers by mitigating risk and solving problems. 

This position reports to the Senior Manager, New Business in Bloomington, Indiana.

The responsibilities:

• Primary client facing role covering all aspects of product life-cycle, including proposal, contract, technical transfer and validation through commercialization. Supporting marketing and sales campaigns in order to understand client and market needs
• Performing technical evaluations of incoming new project opportunity requests, facilitating the Potential Product Evaluation and PAC meetings, initiating pricing discussions with finance, business development, sales and marketing and writing the final customized business proposal committing to scope, timeline, and cost.
• Participating in contract negotiations as decision maker for technical and site-specific business topics, as well as contract enforcement following agreement execution.
• Actively supporting client‘s filing and customer relationship management and business development initiatives to ensure client satisfaction.
• Ensuring smooth transfer to commercial team upon successful completion of project tech transfer and validation.
• Ownership of the Client Forecasting and Demand/Supply Obligations (Sales & Operations Planning) and ownership of client program Quarterly Business Review Meetings.
• Ensures roles and responsibilities are clear across internal and external organizations to achieve desired results.
• Leads internal and external project team meetings and ensures clear actions are documented and committed enabling timeline achievement.
• Ensures collaboration and respect are maintained in all experiences while constructively providing appropriate guidance and feedback.
• Primary contact for ongoing client projects and uses best practices in communication processes. Minimizes extraneous information and reduces non-essential communications. Manages information appropriately with all parties while sharing feedback and insight to drive improvements.
• Establishes expectations with all stakeholders and customers through clearly documented processes (Project Tracker, Scope Document, Timeline, and SharePoint). Ensures understanding through direct and active communication channels.
• Determine appropriate service recovery response and deliver message and appropriate action to customer while coordinating with internal partners. Effectively manages trade-offs between customer service, profitability and capabilities.
• Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies internally and/or with clients to ensure optimal results. Manages project interdependencies by use of project management tools that support monitor/control and effective risk management.
• Coordinates agreed upon scope change control when a change is proposed, ensuring financial obligations are assessed/collected from customer due to changes or additions to project scope.
• Utilizes Action Item List, timelines, project scorecards, project metrics, and deliverable tracking to drive project performance and ensure facility personnel understand progress and critical attention areas.
• Identifies opportunities for improvement and ensures internal partners take ownership and drive results.\Achieves billable project activities per business guidelines and approved project plans. Works with customer and sales to ensure additional work activities are billed and that the project meets profit guidelines.
• Contributes technical and product knowledge throughout the project lifecycle and understands balance and timing of involving appropriate technical resources throughout the project lifecycle through other experts when needed.
  
  

Required qualifications:

• Bachelor’s degree required, preferably in a business or scientific discipline
• Minimum of three years of pharmaceutical product development or manufacturing experience preferred and three years of project management experience preferred, preferably in a service business.
• Must be well versed in Project Management tools and must possess knowledge of related disciplines
• PMP certification desired
• Computer proficiency in Microsoft Word, Excel, PowerPoint, and Outlook and the ability to use enterprise software (examples include: JDE, Veeva, Trackwise, etc.)
  
  

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may involve walking or standing for periods of time
• Ability to qualify for Grade C gowning 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.

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 Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Quality Manager.

The responsibilities:

• Primary quality contact for assigned clients externally and internally.
• Manages client project quality updates and reviews with all levels of management.
• Responsible for making and delivering accurate and timely quality decisions pertaining to client projects,
• questions, and quality requests.
• Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for
• corrective action implementation.
• Partners with manager and Quality leadership staff to author, drive or approve applicable quality documents,
• as the Quality representative in a timely manner.
• Partners with Program Manager, Technical Services Representatives, Quality Control Representative and
• Manufacturing Representative to coordinate projects, provide support, align facility representation, and
• provide consistent quality information.
• Represents Quality in required Project Client Meetings.
• Understands the quality and technical requirements of each project.
• Maintains Project File, including recording and tracking quality interaction with client. Track, trend, compile,
• and report client quality metrics as necessary.
• Thoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master
• Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship
• and product.
• Assist and lead quality agreement contract negotiations
• Identifies and leads continuous improvement activities to maximize business results.

The requirements:

• Bachelor’s degree required, preferably in a science related field with 5 years pharmaceutical industry experience or a Master's degree with 3 years of pharmaceutical experience.
• Familiar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical,
• biological and biochemical quality.
• Knowledge of worldwide regulatory requirements
• 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:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long hours 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.

The Role:

The Sr Manager, Supply Chain Planning manages the long term and short term planning functions for their assigned section of the business as part meeting the overall objectives of the organization. This role supports all supply chain aspects of planning from forecast through staging of firm batch material. The Sr Manager, Supply Chain Planning facilitates continuous improvement and ensures support and alignment with the overall facility initiatives.

The Responsibilities:

• Accountable for maintaining executable schedules to meet manufacturing daily requirements through a team.
• Provide guidance and leadership in all aspects of planning from forecast entry, order creation, material planning, through staging of materials for production.
• Responsible to support and lead S&OP/Operating Review meetings – identify business critical issues and facilitate discussion and decision making in support of goals and objectives.
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Assist in setting performance objectives and development plans.
• Responsible for working with Directors to develop strategies and plans for maturing the organization.
• Works with Project Management, Manufacturing, Process Validation, Warehouse, Maintenance, Engineering, and Technical Services in support of business objectives.
• Lead and facilitate cross functional teams in support of strategic initiatives both within the SC organization and across the business units.
• Accountable for embracing change, challenging status quo, and making recommendations for improvements to projects and processes.
• Analyze complex data with the understanding of trade-offs between different business objectives and present recommendations and assist in determining the feasibility of projects based on facility capacity.

The Qualifications:

• Bachelor’s Degree required.
• Minimum 5 years experience in Supply Chain or Supply Chain Planning preferred.
• Leadership experience preferred.
• Good working knowledge of Enterprise Resource Planning required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.)

Physical / Safety Requirements:

• 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 Senior Technical Transfer Associate (MSAT) is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

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
  • Short and Long-Term Disability 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
  • 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 12/31/24

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.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

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

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-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:

A Utilities Engineer is responsible for continuous improvement, technical support and troubleshooting as required on critical utility systems. This role will be responsible for maintenance programs for all existing critical utilities (preventive, reactive, corrective and predictive) and improvement projects, including managing vendor relations, procurement, installation, and functional testing to achieve both budget and timeline requirements. This position is 100% onsite at the Bloomington facility and reports to the Manager of Process Engineering.

The Responsibilities:
• Support in the design and maintenance of utilities and associated systems - including, but not limited to, cooling towers, compressed air generation and distribution systems, chilled water generation and distribution systems, air handling units (AHUs) supporting aseptic processing operations, electrical distribution and backup systems, boiler/steam generation and distribution systems, clean steam generation, fire suppression, water for injection (WFI) production and distribution to points of use
• Monitor and troubleshoot utilities systems and associated equipment to identify and resolve any issues promptly to minimize downtime
• Responsible for and active supervision of technical building systems in the GMP environment, including electricity/emergency power, refrigeration, cooling and vacuum technology
• Detailed planning and implementation during shutdowns, new installations, and process optimization of utilities systems
• Create cGMP/GDP-compliant lifecycle documentation, maintenance, qualifications procedures and operating instructions, including change controls as necessary
• Subject matter expert for building monitoring and work order systems
• Continuous improvement of facilities and processes using LEAN tools and methodologies
• Collaborate with cross-functional teams to ensure utilities systems are integrated effectively into manufacturing processes
• Develop and execution of preventative maintenance plans for utilities systems and associated equipment to ensure optimal performance and compliance
• Stay current with industry regulations and best practices, ensuring utilities systems meet all safety and quality standards
• Provide technical expertise and guidance to junior engineers and technicians within the teams
• Drive continuous improvement initiatives to enhance the efficiency, reliability, and sustainability of utilities systems and associated equipment
• Preparation and maintenance of documentation, including standard operating procedures, equipment manuals, and maintenance records
• Utilize root cause analysis techniques to investigate process and equipment issues and sustainable and preventatives actions
• Own the qualified state of the critical utilities equipment

What you'll bring:
• BS degree in Engineering or Technology required
• 3+ years’ experience in a pharmaceutical industry or in a highly regulated role
• Working knowledge of high and low voltage electrical switchgear and distribution systems
• Working knowledge of common project management tools
• Experience with generation, operation, and use of clean steam and WFI generation systems
• Understanding of controls, wiring and circuitry
• Experience with hydraulics & pneumatics, and operation of air handling systems
• Experience with automation and programmable logic control (PLC) systems

Physical / safety requirements:

• Ability to wear required personal protective equipment (PPE) 
• Ability to work overtime, nights, and weekends as business needs require 
• Must be able to lift up to 50lbs
• Must be able to gown qualify for Grade A/B area
• Position requires sitting or standing 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:

The Sr. Manager of Engineering & Maintenance (E&M) leads a team of Process Engineers, Maintenance personnel and Equipment Coordinators to support all aspects of secondary packaging for parenteral pharmaceutical products. This position is part of a cell-based building management structure, complimented by peer leaders from Operations, Quality, and Technical Services departments. The incumbent will be responsible for leading a department with foundational expectations centered on safety, quality, execution, collaboration, and process improvement to support cell operational metrics and overall plant goals & objectives. The position reports to the Associate Director Engineering & Maintenance Operations.

The responsibilities:

• Responsible for maintaining departmental headcount and all associated administrative and planning functions, including interviewing candidates, hiring, onboarding & training, personnel development, performance management, scheduling, directing day-to-day activities and project oversight
• Responsible for equipment performance, preventive/scheduled maintenance, emergency maintenance, vendor scheduling, and project management - including timely repair and sourcing of critical parts or components
• Responsible for coordinating all activities and/or repairs related to facilities maintenance for building
• Responsible for Total Productive Maintenance (TPM) program focused on identifying overall equipment efficiencies to enhance production processes and quality
• Supports identification and procurement activities related to new process equipment. Includes generation of user specification documents, installation, commissioning, and qualification activities Provides oversight and management for process engineers regarding project ownership, including collaboration with CAPEX project engineers, and project timelines
• Works closely with peer cell leaders towards common goals to track and report department specific metrics within the cell
• Responsible for identification and implementation of corrective actions to improve performance and compliance
• Complies with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), and rigorous quality standards and holds team to same expectation
• Maintains a clean and safe work area using 6S (6 Sigma) principles
• Ensures team is compliant with safe work practices and electrical requirements, including LOTO (Lock Out, Tag Out), safe work permits, and all Personal Protective Equipment (PPE) required to safely complete assigned work
• Lead and/or support a variety of complex issues & projects as applicable
• Apply technical expertise and troubleshooting philosophies with a variety of technologies including: syringe & vial aseptic filling machines and related process equipment, autoclaves, lyophilizers, terminal sterilizers, isolator systems, Human Machine Interface (HMI), PLCs, clean utilities, HVAC, SCADA systems and electrical control systems
• Ability to troubleshoot complex automated machinery and manual/mechanical based equipment or applications
• Fully accountable for the performance of self and team

Required qualifications:

• BS degree in Engineering or a related field of study
• 7+ years of manufacturing experience
• Prior experience and familiarity working in a cGMP environment
• 3+ years of leadership / supervisory experience 
• Demonstrated examples of successful project execution
• Track record in technical management of process equipment in a manufacturing environment, with experience in electrical, mechanical, and automated applications
• Able to analyze and solve complex problems
• Knowledge of GMPs, FDA guidelines, purchasing practices and process validation
• Team building experience in guiding multi-disciplinary teams on medium complexity issues, while providing technical direction to individual engineering disciplines
• Ability to translate business goals into action plans
• Understanding and proficiency in reliability-centered maintenance principles and practice
• Results-oriented mindset, capable of independent thought, adaptable, ready to respond and react to real-time situations with realistic and viable technical, organizational, and administrative solutions
• Advanced proficiency in Microsoft Office Suite
• Ability to utilize enterprise software applications: Maximo, Veeva, Microsoft Dynamics, Blue Mountain
• Ability to communicate effectively and professionally
• Ability to write and review technical documents
• Demonstrated efficient written and verbal communication skills
• Minimal travel required (less than 10%), including potentially supporting equipment FAT
• Ability to apply and utilize Root Cause Analysis (RCA) tools

Physical / safety requirements:

• Ability to stand or sit for extended periods of time
• Ability to utilize required personal protective equipment (PPE)
• Dexterity and physical condition to perform some level of repetitive motion tasks

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 Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes. The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Services Validation Manager.

The responsibilities:

• Document (protocols, SOPs, summary reports) new processes and update existing processes where vital that will be reviewed by clients, corporate and regulatory auditors
• Conduct development studies on critical equipment
• Owns and onboards new client projects, including the relevant validations on syringe lines
• Serve as line owner, conducting gap assessments and determining validation approaches when onboarding new projects
• Collaborates directly with client representatives
• Owns non-conformance investigations (NCR)
• Owns corrective and preventive actions (CAPA)
• Owns change control management tasks (CCM)
• Participates in client audits and provides rationale / justification for practices with aid from senior team member / management Responds to audit observations and owns deliverables
• Subject matter expert for up to 3 processes, technologies or process equipment
• Owns, plans interventions and leads syringe line media fills and has full ownership through closure of the summary
• Owns & drives value improvement projects (VIP) to realize savings
• Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing)

Required qualifications:

• BS degree in science related field with laboratory experience or High School diploma/GED with a minimum of 6 years related experience within a pharmaceutical, biotechnology or related industry including responsibilities comparable to this position (e.g., technical writing, audit experience, project lead, authoring and performing studies, etc.)
• Microsoft Office Suite (Word, Excel, Outlook) intermediate proficiency
• Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.)
• Critical thinking and problem-solving skills
• High initiative and ability to deal with ambiguity
• Skills to interact professionally and collaboratively with the client representatives
• Good writing skills - including technical writing
• Strong oral and written communication - including communication with external clients

Physical / safety requirements:

• Ability to meet Grade A and B gowning requirements.
• Ability to lift 50 lbs.
• Must be able to climb and work from ladders.
• Duties will require some overtime work, including nights and weekends
• Position requires standing for long hours, but may involve walking or sitting 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/

The Security Technician is responsible for managing all aspects of access control and IP Camera products and systems installed at client sites. The Security Technician must be able to independently install, program, troubleshoot and perform maintenance on electronic devices, power supplies and all network components. S/He will need communicate effectively with the Field Supervisor and present a knowledgeable and engaging image to customers.
The Security Technician must be a self-starter who can make sound decisions that are in the best interest of the project, the customer, and Unlimited Technology. Further, the Security Technician able to work closely with subcontractors and customers. 

Duties and Responsibilities
As a Security Technician, the successful candidate will need to be hard-working, detail-oriented, highly organized and able to work independently to maintain security hardware in the client’s and Unlimited Technology’s best interests.

• Install and service Access Control and IP Camera systems according to engineered drawings.
• Must possess programming skills associated with the UT product line.
• Program, terminate and commission a wide range of Access Control products and platforms..
• Must be able to identify and resolve issues that would have a negative impact on job productivity.
• Thoroughly complete all necessary paperwork relating to job tickets.
• Maintain a safe, clean working environment always.
• Communicate all activity to the job Project Manager or Field Supervisor in a timely manner.
• Maintain the condition and cleanliness of any company provided vehicle.
• Maintain a safe driving record and report any incidents or near misses to management immediately.
• Attend any product or safety training that is required.
• Travel 50% required in IN area 

Requirements

• High School diploma or equivalent.
• Minimum 3-5 years of field installation experience in the security environment.
• Certifications in Software House and Genetec a plus 
• Certifications in American Dynamics, Bosch and / or other products a plus
• Experienced in the installation of door hardware such as strikes and magnetic locks.
• Experience in Audio Visual Technology
• Excellent communication skills (verbal and written) and the ability to work well and interact with other UT employees as well as UT customers.
• Strong work ethic and teamwork; “can do” attitude and desire to provide best service. Strong interpersonal and communicative Skills.
• Ability to work under pressure with minimal supervision; must be a self-starter and quick learner.

• Coordinate MCN and ECN workflows from initiation through implementation, tracking changes through defined gates and ensuring timely completion of cross-functional actions.
• Prepare and distribute Change Control Board (CCB) meeting packages, agendas, and action item logs.
• Maintain the change control log and tracking tools (Smartsheet), ensuring data accuracy and status visibility for all stakeholders.
• Follow up with cross-functional team members (engineering, quality, manufacturing, supply chain, maintenance) to drive action closure.
• Support trial planning and execution for manufacturing changes, including readiness checklists, parts availability, and data capture.
• Coordinate implementation follow-through on change-driven actions including BOM updates, work order modifications, and Work Instruction revisions.
• Facilitate review meetings, document decisions and approvals, and track open items to closure within agreed timelines.
• Escalate systemic or high-risk issues to the appropriate engineering, quality, or program management lead.

• Assist area TPMs with smaller launch activities including milestone tracking, readiness gate preparation, and issue resolution.
• Support launch wall updates and reporting for assigned activities.
• Coordinate documentation updates for launch-related changes including Work Instructions, PFMEA, and Control Plans.

• Ensure all change and launch documentation meets plant standards for completeness, accuracy, and revision control.
• Communicate change status, risks, and escalations to the Change Management Lead and PM team.
• Maintain organized records of change history, dispositions, approvals, and supporting documentation.
• Support ERP transactions in NetSuite related to change activity as needed.

• Bachelor’s degree in Engineering, Manufacturing, Industrial Engineering, Business Administration, or related field.
• 8+ years of related experience with a Bachelor’s degree, 6 years with a Master’s degree, or 3 years with a PhD, or equivalent professional experience.
• Experience in automotive or high-volume manufacturing environments, preferably in change control, non-conformance management, launch coordination, or program management support roles.

• Strong organizational skills with the ability to manage multiple concurrent changes and priorities.
• Understanding of manufacturing change control processes (ECR/ECN), non-conformance/deviation workflows, and manufacturing documentation (Work Instructions, PFMEA, Control Plans).
• Proficiency with Smartsheet, Excel, and project tracking tools.
• Working knowledge of ERP systems (NetSuite) for inventory, work order, and change-related transactions.
• Strong cross-functional communication skills and ability to drive accountability without direct authority.
• Detail-oriented with a focus on process discipline and follow-through.
• Familiarity with PLM systems (Windchill, Teamcenter) a plus.
• Familiarity with quality management systems (IATF 16949, ISO 9001) preferred.
• PMP, Six Sigma, or Lean certifications helpful.

Job Summary: 

Real Chemistry is looking for a Senior Account Manager to join our growing Earned Media team!   

This role can be remote, TX, Carmel, IN, remote FL, remote TN, or remote PA. 

What you’ll do:  

• Prepare well-crafted pitches and strategic media recommendations, integrating PESO and analytics 
• Strategic execution of routine work including media list development, reporter briefing sheets, media audits 
• Able to run and track media projects with limited consultation from senior peers 
• Lead local,tradeand select national/consumer media outreach  
• Maintainand prepare media outreach summaries and updates for internal teams and clients  
• Support organic and new business development efforts (i.e.media research, slide preparation support, etc.) 
• Manage media projects byanticipatingchallenges, maintaining media budgets, and working with cross functional teams  
• Integrate and collaborate with cross-functional leaders (social, paid, search, analytics) 
• Effectively set, manage, and communicate media expectations with team and clients 
• Has general understanding of sponsored opportunities (STAT), influencer programs, and presents opportunities to recommend them 
• Accountable for coaching and developing junior staff 
• Attend client meetings as needed

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• Bachelor’s degree or equivalent experience
• 3-5 years of relevant experience 
• Excellent project management skills, including solid attention to detail 
• Effective organizational,writtenand verbal communication skills  
• Ability to juggle multiple assignments, meet project deadlines, and effectively communicate shifts in project timeline 
• High-level understanding of how PESO plays out in today’s modern media world 
• Experience with medical meeting support and orchestrating regulatory milestones 
• Thought leadership and sponsored content experience 
• Ability to read new business analytics reports and suggest basic insights for earned mediaportionof pitch  
• Proactive communication across internal and external teams 
• Excellent time management

What You'll Do

Driving New and Organic Growth 

• Expand use of Ceribell to additional acute or critical care centers within existing customer base.
• Work with the local Territory Manager to launch Ceribell at new customer sites.
• Drive new product and technology introductions for existing customers.
• Build advocacy and champions within facilities.  Use hospital data to validate and build interest.
• Develop a qualified lead funnel within existing install base.  Regular activities consist of formal presentations, peer to peer education, new physician training, and driving physician education.
• Responsible for upgrades and departmental expansion in existing install base.
• Strong project management skill requirement to support new account launches.

Clinical Training / Education

• Educate and train physicians, hospital personnel and/or office staff on the merits and proper clinical usage of company products.   Become a clinical expert in use cases of Ceribell and relevant patient populations. 
• Troubleshoot workflow solutions for departments as need arises
• Partner with clinicians to identify and establish protocols for patients at risk of seizure.
• Lead clinical teams through training sessions helping understand workflow and applications.

Reporting and Administration

• Submit all required reports and training documentation on a timely basis
• Use Salesfoce.com to manage administrative task
• Ensure compliance with applicable laws, regulations, and Ceribell policies
• Works cross-functionally to ensure successful deployment of Ceribell products at customer locations.
• Ability to work within a field-based team and strong partnership with Territory Manager of respective region.

What We're Looking For

• 3-5 years of recent critical care sales experience OR 5 years of medical device or pharma sales experience OR RN’s with industry experience in supporting sales teams.
• Excellent Communicator, Relationship Builder, Creative & Effective Problem Solver, highly organized and ability to prioritize strategically.
• Ability to accurately assess and understand different stakeholders needs/wants. Process cross functional agendas and adjust strategy to achieve desired outcomes.
• Confidence and expertise required to effectively challenge the status quo and influence meaningful change through consensus building
• Driven & Coachable: innate desire to succeed; willing to seek out coaching, accept feedback and apply new skills supports measurable change
• Grit, high integrity 
• Bonus points: start-up experience or experience working with disruptive technology, med device experience, neuro ICU clinical experience, sales experience.

#LI-EK1

Job Introduction: We are seeking an experienced Senior Program Manager to lead the delivery and implementation of critical manufacturing and quality systems, including MES, CSV, and EMS, within a fast-paced, high-visibility pharmaceutical manufacturing environment. The ideal candidate is a hands-on leader who can drive execution across cross-functional teams, proactively manage risk and ambiguity, and ensure projects are delivered on time, with quality, compliance, and strong stakeholder alignment.

Senior Program Manager Responsibilities:

• Lead end-to-end project delivery across MES, CSV, and EMS initiatives
• Manage project scope, schedule, budget, risks, and dependencies
• Drive coordination between IT, Quality, Manufacturing, and external vendors
• Ensure all systems and processes align with GxP and regulatory expectations
• Oversee validation activities, including planning, execution, and documentation
• Facilitate issue resolution and decision-making across stakeholders
• Provide clear and consistent status reporting to leadership
• Support integration efforts across manufacturing and enterprise systems
• Maintain strong governance and change control throughout the project lifecycle

Job Requirements:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical), Project Management, or related technical field
• 7–12+ years of project management experience in life sciences or regulated industries
• Proven experience delivering MES implementations (e.g., PAS-X, Syncade, Opcenter, etc.)
• Strong background in CSV and validation methodologies (CSA preferred)
• Experience with EMS platforms and integration into manufacturing environments
• Experience with SAP and other Enterprise platforms
• Demonstrated ability to operate in fast-paced, high-pressure environments
• Strong stakeholder management and communication skills
• Experience managing vendors and system integrators
• Familiarity with GxP, 21 CFR Part 11, and data integrity requirements
• Experience supporting greenfield or startup manufacturing environments preferred
• Exposure to biologics, cell and gene therapy, or similar advanced modalities preferred
• PMP or equivalent certification preferred
  

Real Chemistry is looking for a Account Manager/Senior Account Manager join our growing team!   

The Account Manager/Senior Account Manager for the Scientific and Medical Affairs is the client’s key day-to-day contact, managing relationships and helping to set their expectations of the agency. You make sure that your colleagues know what is going on and are delivering effectively. You are thinking about future opportunities as well as today’s work.   

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:  

• Day-to-day client contact: provide regular status updates to your client; respond to client queries and share recommendations (following discussion with your account lead); manage client expectations on timelines, scope of project, etc.; take client briefs and clearly communicate to team members, implementing realistic project plans  
• Take responsibility for the day-to-day management of your account, including managing the processes of the account (including running regular internal team meetings), flow of work, delegation of tasks (oversee status reports to ensure all team actions are complete) and the status of jobs across the account (not just your own)  
• Ownership of and accountability for medium/large client projects, ensuring that projects are delivered to highest possible standards within budget and agreed timeframes  
• Ongoing communication with your account lead on the progress of projects; alerting them to any barriers to project completion and being proactive in making recommendations and proposing solutions on how to proceed  
• Awareness of the client’s business priorities and a sound understanding of the program strategy; have a good understanding of competitor activity  
• Keep abreast of trends and developments in the medical communications and pharma industries  
• Start to identify areas for growth (evolving existing programs and/or additional tactics), proactively sharing new ideas with your team and client  
• Keep abreast of market changes  
• Be proactive when new business opportunities arise, flagging relevant experience and areas of interest, contributing thoughts and ideas, assisting in the production of credentials and pitch presentations  
• Maintains general understanding of account finances; supports account lead with financial management  
• Support new business research and ideation, participate in pitch presentations as required 
• Continued professional development engagement; work with manager to identify training opportunities based on areas of interest and need  

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are a highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• A minimum of 3 years of prior experience in healthcare agency client services roles with medical affairs, publications, and/or medical information experience required 
• Highly organized with a mindfulness of deadlines, the ability to manage multiple tasks based on priorities and a strong attention to detail  
• Independent thinker confident in taking ownership of assets and material development, but a team player who enjoys collaboration  
• Professional presence, performs with a sense of urgency and with a client service orientation  
• Has confidence to manage upward when required; able to communicate with managers when deadlines will not be met or when issues are foreseeable  
• High energy, able to effectively operate in fast-paced, growing and evolving environment  
• Demonstrated strong work ethic, with a track record of following through on client requests and with high-quality deliverables on schedule and on budget  
• Able to work independently and as part of a team 
• Competent in using Microsoft Word, PowerPoint, Excel, and Outlook 
• Experienced in developing client relationships and networking 
• Strong financial acumen 
• Comprehension of project and account objectives, contributing to strategic planning 
• Able to devise and articulate solutions to problems on an ongoing basis  
• Able to clearly communicate project updates, scopes and recommendations to clients  
• Veeva management and/or iEnvision experience recommended but not required  
• BA or equivalent work experience required  

Pay Range: $70,000.00-$100,000.00

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.  

About the Job

This is a high-impact leadership role at the center of our manufacturing and technical operations. As the Senior Manager of Engineering, you will lead the engineering and maintenance function supporting GMP/GTP manufacturing, ensuring equipment, processes, and systems remain reliable, compliant, and scalable as we grow.

You will partner closely with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as both a technical problem solver and a strategic enabler of safe, high-quality, and reliable product supply. As a key member of the Site Operations Team, you will drive disciplined execution, risk-based decision-making, and continuous improvement across the site.

This role is ideal for a technical leader who thrives in complex, regulated environments, builds strong and accountable teams, and is energized by modernizing systems to support increasing production demand and new product launches. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Engineering and 8+ years of experience in pharmaceutical or biotech manufacturing OR 12+ years of relevant engineering experience in a regulated manufacturing environment
• 4+ years of people management experience leading engineers or technical staff
• Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments
• Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
• Proven track record of improving equipment reliability and reducing unplanned downtime
• Strong project management, documentation, and communication skills
• Experience with root cause analysis, FMEA, and SOP development
• This position is based full time onsite in our Indianapolis facility

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing, including tech transfers, in multiple functional areas
• Familiarity with computerized maintenance management systems (CMMS)
• Experience leading capital projects and facility expansions
• Lean or Six Sigma certification
• Experience implementing automation and digital engineering solutions
• Experience interacting with regulatory inspectors (FDA, EMA, or equivalent)
• Expertise in business intelligence and analytics (Tableau, Power BI, SQL)

Key Responsibilities

• Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel
• Be a key member of our Site Operations Team, ensuring reliable supply of product to patients
• Own equipment lifecycle management including design input, commissioning, qualification, maintenance strategy, and retirement
• Oversee capital projects from concept through execution, ensuring scope, budget, and timelines are achieved
• Establish and improve preventive maintenance and reliability programs to reduce downtime and deviation risk
• Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion
• Ensure engineering compliance with CGMP/CGTP, safety standards, and internal procedures
• Lead root cause investigations related to equipment, utilities, and facility systems
• Drive data-based reliability improvements using trend analysis and KPIs
• Support inspection readiness and represent Engineering during regulatory audits
• Develop long-term facility and infrastructure strategy aligned with commercial growth plans
• Travel (domestic and international) when required (<10%) to support other sites

In your first six months some projects you’ll work on include:

• Assessing current equipment reliability, PM effectiveness, and engineering KPIs
• Implementing a new CMMS software platform
• Identifying and prioritizing capital investments to support production growth
• Standardizing engineering documentation and technical standards
• Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

Job Summary:

This position works in the field directing Instrument Person(s) and completes houseline surveying services, topographic surveys, tree surveys, wetland surveys, boundary surveys, and ALTA surveys. They also complete control surveys and bench loops, as well as construction staking services within quality standards. This person will live in northwest Indiana and visit the Chicagoland offices once per quarter. The role requires an independent and driven Crew Chief who is good with time management, communication, and mentorship. 

Accountability and Duties:

• Ensures timesheets are submitted accurately and on time.
• Provides an accurate accounting of time spent on projects with descriptions for each time entry on a daily basis.
• Keeps supervisors informed of workload and any changes in project scope or additional services.
• Maintains a good relationship with clients and staff.
• Works closely and coordinates with staff and site superintendents.
• Understands and accurately uses all field survey instruments.
• Properly maintains and takes care of field equipment.
• Obtaining & reading information for the daily projects.
• Maintain and electronically file legible field notes and sketches,
• Successfully upload and download data files to/from collector.
• Successfully upload and download calibration files to/from collector.
• Responsible for stocking the company vehicle each morning (supplies & equipment).
• Properly maintains, cleans, and takes care of field vehicle.
• Accurately completes houseline surveying services.
• Accurately completes topographic, tree, and wetland surveys.
• Accurately completes boundary and ALTA surveys.
• Accurately completes control surveys and bench loops.
• Accurately completes construction staking services.
• Accurately completes record drawings and as-constructed surveys.
• Checks control sheets and block sheets and coordinates information with office surveyors.
• Understands and accurately uses Trimble Business Center and other required software.
• Ability to make independent decisions within the general framework of projects.
• Checks in with the client (on-site) upon arrival and departure daily.
• Communicates with Survey Project Manager and/or Staff Surveyor on a daily basis.
• Complete projects efficiently and within Atwell quality standards.
• Mentors and trains Instrument persons and Survey Interns.
• Mentors and trains Engineers and Surveyors cross training in field.
• Accurately completes commercial building column staking services.
• Understands engineering plans and reviews for potential field problems.
• Efficiently coordinate multiple field staff on job sites.
• Find ways to improve our abilities to use and understand field equipment and software.
• Looks for opportunities to improve standard procedures and quality standards.
• Demonstrates leadership qualities and mentors other crew chiefs.
• Completes construction calculations and block sheets in CAD.

Qualification Requirements:

Must have a High School Diploma and/or Surveying Degree with 5-8 years’ experience

Education and/or Experience:

High School Diploma and/or Surveying Degree with 5-8 years’ minimum experience

Certificates, Licenses, Registrations:

Valid driver’s license

Required Knowledge, Skills, and Abilities:

• Excellent oral and technical written communication skills.
• Ability to direct instrument persons and other field surveyors.
• Strong sense of urgency and self-initiative to meet client deadlines.
• Available to work overtime as needed to complete projects.
• Available to work in the field in all weather conditions.
• Desire to learn and improve field skills and survey knowledge.
• Ability to make independent decisions within the general framework of projects
• Must be fluent in the English language

WORK ENVIRONMENT OR PHYSICAL DEMANDS

The physical demands described here represent those that an employee must meet to successfully perform the essential functions of this job. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

The employee will:

• perform work primarily outdoors at construction sites, landfills, and in traffic.  Work may be performed for extended periods of time in various terrains, climates, and possibly in adverse weather conditions.
• perform moderately strenuous tasks, such as lifting and carrying survey equipment/instruments weighing up to 75 pounds over rough terrain.
• climb or balance and stoop, kneel, crouch, or crawl
• clear vegetation, dig holes, and pound stakes with hand tools 
• stand; walk; use hands to finger, reach with hands and arms, or feel and talk or hear

Employer’s Disclaimer:

• This job description is meant to describe the general nature of work performed. It is not intended to be construed as an exhaustive list of responsibilities, duties, and skills required for the position.
• The Firm reserves the right to add or revise an Associate’s job duties at any time at its sole discretion.
• This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

Pay Range: $40-47/hour

#LI-AB1

The Clinical Material Coordinator and SAP Process Owner is responsible for the business processes associated with inputting molecules into SAP, as well as movement of materials within internal clinical trial manufacturing sites and manufacturing at external collaboration partners. This includes the logistics associated with drug substance and drug product shipping, sample shipment and storage and raw material coordination. This role will support manufacturing across the Product Research and Development (PRD) Organization. The Material Coordinator will represent the Clinical Manufacturing organizations to streamline communications with Clinical Supply and Delivery and the supporting QA teams.

Clinical Material Coordinator Responsibilities:

• Establish SAP and Business processes to support material movements, both physically and within SAP and Quality Systems, for all PRD organizations.
• Maintain SAP data related to orders in support of the organization, this includes:
  • Establish new materials and purchasing information aligned with sourcing decisions
  • Create new vendor and customer numbers as needed
  • Establish Source List for triangulated sales products as needed
  • Accountable for MRP (Manufacturing Resource Planning) actions from the point of demand entry, purchase order creation through successful incoming receipt; reconciling any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is done and batch release
• Manage shipment of drug substance and samples to contract partners, warehouse, and testing facilities
• Own and optimize drug substance release huddle with development and QA to align on priorities, actions and approvals
• Communicate and work with Manufacturing Plant Planners on scheduling constraints and issues that require an adjustment to the plan in regard to drug substance availability and delivery, including drug substance representative at huddles
• Build strong relationships with development organizations through routine touch points
• Monitors delivery due dates and notify development or commercial teams when shipment of drug sub-stance is needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP as necessary
• Accountable for document exchange with the contract partner (e.g., ticket copies, CT packet, CoA's and other supporting documents regarding raw materials and components) and upload into internal system
• Coordinate activities and communicate timing on incoming and outgoing shipment schedules
• Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is complete
• Conducts periodic inventory reconciliations
• GMP Compliance
• Must be knowledgeable on how to apply GMPs in a clinical trial environment. Authors, reviews, and follow procedures applicable to the Clinical Trial business. In addition, individual training plans must be kept up to date
• Quality Assurance
  • Authors appropriate deviations (e.g., L1 temperature excursions, shipping, samples)
  • Participates in departmental site self-assessments and relevant audits

Requirements:

Skill Set:

• Excellent oral and written communication skills with the ability to interact well in a team environment
• Ability to develop/manage relationships with contract partners
• Ability to collaborate with partners around the world
• Initiative and ability to handle multiple projects in an independent fashion
• Excellent organization and self-management skills
• High initiative, flexible and positive attitude
• Ability to respond to changing priorities and short lead times

Technical:

• Experience with SAP
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial manufacturing operations
• Ability to use and apply multiple computer applications
• Ability to proactively identify problems and work toward a solution
• Minimum 1 year in a GMP environment

Education:

• Bachelor’s degree, preferably in health care or sciences related field or 10+ years’ work experience in supply chain or operations

Onsite job requirement in Indianapolis, IN.

Real Chemistry is looking for an Associate Director join our growing Earned Media team!   

This role can be remote, TX, Carmel, IN, remote FL, remote TN, or remote PA.

What you’ll do:  

• Work directly with a variety of clients in the biotech and pharma spaces to manage media strategy, execution and related internal/external media expectations 
• May serve as day-to-day client contact for media needs on select accounts and as a strong #2 on others 
• Manage and own media engagement with local, trade and some national & top-tier media/journalists 
• Track and prepare media outreach summaries/updates for internal teams and clients 
• Support organic and new business development efforts (i.e. media research, slide preparation support, etc.) and actively contribute to new business decks, along with smaller-scale presentations representing earned media team 
• Manage media projects by anticipating challenges, maintaining media budgets, and collaborating with cross functional teams 
• Lead broad-based earned media workstreams and manage internal and external client expectations 
• Maintain core relationships with reporters by meeting regularly and sharing learnings with teams and clients 
• Serve as knowledge relationship manager for key sponsored content outlets (STAT, etc.) and share information more widely 
• Responsible for providing integrated, 360-degree PESO thinking 
• Collaborate with the analytics and influencer teams to identify influencers to engage and activate 
• Accountable for training junior staff on Real Chemistry processes, responsibilities and the healthcare media landscape 
• Integrate and collaborate with cross-functional leaders, understand cross-functional capabilities and motivate cross-functional teamwork(social, paid, search, and analytics teams) 
• Set clear performance objectives and utilize all management tools to communicate alignment and performance measures 
• Embodies and incorporates Real Chemistry Core Values 

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• Bachelor’s degree or equivalent experience
• Minimum 5 years of relevant experience 
• High-level understanding of how PESO plays out in today’s modern media world 
• Excellent project management skills, including solid attention to detail 
• Highly effective organizational, written and verbal communication skills 
• Ability to juggle multiple assignments with ease and flexibility 
• Can effectively and confidently present to internal and external audiences in a variety of ways 
• Understands how to maintain media budgets and media scopes 
• Demonstrates deep understanding of the integrated media landscape as well as related firm resources (notably analytics) 
• Experience with medical meeting support and orchestrating regulatory milestones 
• Thought leadership and sponsored content experience 
• Able to plan projects and proactively delegate responsibility, communicating deadlines clearly 

Job Summary: 

We are seeking an outstanding Senior Account Manager to join our growing team. Real Chemistry is looking for driven, savvy game changers who are ready to dive into the trenches and make an immediate impact!   

The ideal candidate for this role will participate in client projects working collaboratively with internal teams to achieve client objectives through smart, effective and coordinated solutions. Senior Account Managers may also supervise Account Associates and Account Managers. The position offers a phenomenal opportunity for an individual to work with leading clients in the pharmaceutical, biotechnology, and medical devices space.   

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do: 

• Develop presentations, creative briefs, PR materials and other internal/external communications.  
• Participate in development of clients’ marketing strategies and tactics; collaborate with team to ensure consensus around scope and approach. Ensure client feedback is captured, understood, and addressed.  
• Evaluate and analyze data, including developing succinct, accurate summaries and analyses of research that include recommendations for clients.   
• Partner with functional area-experts within the agency in support of coordinated marketing campaigns.   
• Lead all aspects of assigned project(s) fiscal performance and project revenue targets by supervising the teams’ budget, billing, and billable hours. Develop monthly projections and review activity reports and financial trackers.   
• Thoroughly understand and communicates clients’ expectations internally to ensure staffing resources and performance expectations are met.   
• Maintain ongoing, effective communications with client peers to ensure there are no surprises and W2O’s work is meeting all expectations. Participate in quarterly and annual planning and business analysis sessions.   
• May supervise Account Associates and Account Managers to ensure they have a balanced workload, the information and resources needed to meet timelines, and understand client objectives. Provide mentorship and support for career progression and performance.   
• May participate in new business development through proactively identifying and pursuing opportunities to grow existing business.  

This position is a perfect fit for you if: 

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 
• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• 4+ years in a professional environment within the public relations, communications, and / or advertising industries. Healthcare PR experience required. Integrated experience is preferred.   
• Bachelor’s degree or equivalent experience is required.   
• Excellent oral and written communication skills. Ability to explain sophisticated technical terms, clinical trials, and studies pertaining to the brand.   
• Ability to develop, edit, and communicate documents and presentations using Microsoft Office tools (PowerPoint, Word, and Excel).   
• Highly organized, mindful of timelines and budgets, able to multi-task and work under limited supervision in fast paced, growing, and evolving environment.   
• Strong work ethic and professional presence with a track record of following through on client requests and with deliverables on schedule and on budget.   

Pay Range: $68,000-$75,000 
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.   

How You'll Make an Impact: 

As a Senior Fullstack Engineer on the Distribution Team, you'll be instrumental in developing and enhancing the products that connect Cloudbeds' ecosystem to the world's largest distribution channels. You'll architect scalable solutions using modern technologies, contribute to our microservices migration, and ensure our platform delivers exceptional performance and security for thousands of properties worldwide. Your work will directly impact how hotels reach guests through integrations with major platforms like Booking.com, AirBnb and beyond.

Our Distribution Team:

We're the bridge connecting properties to the global travel ecosystem. Our team tackles complex integration challenges that directly impact revenue for thousands of hotels worldwide, from building rock-solid connections with major OTAs to ensuring every booking flows seamlessly and securely. We balance innovation with pragmatism: migrating legacy systems to modern microservices while maintaining the reliability our customers depend on. If you thrive on solving hard technical problems with real business impact and love the challenge of both building greenfield features and refactoring legacy code, you'll feel right at home here.

What You Bring to the Team:

• Design and implement robust backend features and improvements using PHP, with a strong focus on performance optimization and scalability for our distribution platform
• Build intuitive frontend experiences using React and Vue, ensuring seamless user interactions across the Cloudbeds ecosystem
• Architect secure solutions for handling financial transactions and sensitive personal data, applying security best practices throughout the development lifecycle
• Write clean, well-tested, and well-documented code with comprehensive test coverage (unit, integration, end-to-end) to maintain high quality standards
• Lead technical discussions on complex concepts and requirements with both technical and non-technical stakeholders, driving alignment on backend and frontend architecture decisions
• Contribute to our ongoing initiative to migrate core platform components into microservices, helping shape the long-term technical vision
• Re-architect and refactor existing legacy systems to align with modern standards and project requirements, demonstrating ownership and commitment to continuous improvement
• Mentor team members through pair programming and code reviews, promoting best practices that elevate code quality and team processes
• Collaborate with cross-functional teams to plan, build, and ship high-quality features that delight our global customer base

What Sets You Up for Success:

• 5+ years of PHP web application software engineering experience
• 5+ years of experience with JS frameworks, Vue.js and React are preferred
• Solid experience with modern JavaScript/TypeScript
• Strong hands-on experience with Docker and containerized development workflows
• Demonstrated expertise in performance optimization and expert knowledge of relational databases, indexing, and searching technologies
• Strong understanding of security considerations, particularly for applications handling financial transactions and personal data
• Experience with test automation across all levels (unit, integration, end-to-end) and a passion for quality-driven development
• Proven track record of taking ownership of projects and delivering results independently
• Business-level English fluency (verbal and written) and excellent communication skills for collaborating across a globally distributed, remote-first team

Bonus Skills to Stand Out:

• Experience designing and building microservices and/or micro-frontends
• Hands-on experience with PHP frameworks (CodeIgniter, CakePHP, Laravel, Symfony)
• Cloud and infrastructure experience with Kubernetes, AWS, Terraform, and Argo CD
• Experience working with event-driven architectures and messaging systems (e.g., Kafka)

Compensation: Depending on your skills and experience, you can expect your annual compensation to be between $145,000 - $165,000

About the team:

Formic’s Sales Team drives adoption of automation across SMB and mid-market manufacturing. The team partners closely with Engineering, Solutions, and Customer teams to educate manufacturers, develop territory strategies, and build pipeline through disciplined outreach and consultative selling.

About the role: 

As an Automation Sales Manager, you will be responsible for revenue growth and market expansion within your territory. You will develop and execute a strategic territory plan, build deep knowledge of the regional manufacturing landscape, and establish trusted relationships with manufacturers, integrators, and strategic partners.

You will work directly with customers to evaluate automation opportunities, define project requirements, and collaborate with Engineering and Solutions teams to develop system concepts. You will also lead commercial negotiations and own the full sales cycle from initial engagement through contract execution.

This is an individual contributor role responsible for driving territory growth, building a strong pipeline, and delivering consistent revenue performance.

In this role you will:

• Own and execute a regional territory strategy to drive pipeline growth and revenue attainment
• Generate and qualify new business opportunities within SMB and mid-market manufacturing accounts
• Lead consultative discovery conversations and on-site meetings with manufacturing decision makers
• Develop tailored automation solutions in partnership with Solutions and Engineering teams
• Advance opportunities through the full sales cycle from prospecting to contract execution
• Build and maintain executive-level relationships across plant, operations, and ownership stakeholders
• Represent Formic at industry events and trade shows to expand regional market presence
• Maintain accurate CRM data, pipeline visibility, and forecast accuracy
• Analyze regional manufacturing trends, competitor activity, and buyer dynamics to refine territory strategy

What makes you a great fit:

• Proven success in full-cycle B2B sales with consistent revenue attainment
• Experience owning and growing a geographic territory independently
• Demonstrated ability to proactively build pipeline in new or underpenetrated markets
• Strong understanding of manufacturing operations and industrial buying processes
• Ability to navigate multi-stakeholder buying committees and technical decision makers
• Analytical mindset with the ability to quantify value and clearly communicate ROI
• Proficiency with Salesforce or comparable CRM systems
• Willingness and ability to travel up to approximately 75 percent within the assigned region
• Comfort operating in a fast-growth environment with evolving processes and priorities