About this Role

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

Responsibilities

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

Basic Qualifications

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

Preferred Skills and Experience

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

Pay Range

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

Seeking talent near: Princeton, NJ

Position Summary

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

Primary Responsibilities

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

Education and Experience

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

Must possess:

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

#LI-HYBRID #NC1

Data at Brex

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

What You’ll Do

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

Where you’ll work

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

Responsibilities:

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

Requirements:

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

Nice to have:

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

Compensation:

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

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

Principal, Product Strategy 

We are seeking a driven Individual Contributor (IC) to guide business and product strategy for Okta’s workforce product portfolio. This high-impact role demands exceptional depth in strategic thinking, advanced analytical rigor, and the ability to build and sustain trusted advisory relationships across the executive team. This role sits within Okta’s Product and Engineering organization (Okta R&D) reporting to the Head of Strategy & Analytics for Okta R&D, rolling up to the President of Products & Technology, the overall leader of the organization.

Job Duties / What This Role Entails

• Architect Strategic Vision: Collaborate with VP+ level stakeholders across Product Management, Product Marketing, Finance, Corporate Development, and GTM teams to architect and drive next-generation business strategies for the product portfolio. Critically, you will assess the disruptive potential and strategic implications of emerging AI technologies on the Identity Security market and Okta’s competitive positioning.
• End-to-End Strategy Ownership: Own the entire strategic lifecycle: from hypothesis development, rigorous market research and competitive intelligence, opportunity sizing, financial impact modeling, and formulation of high-impact, actionable recommendations, through to X-functional alignment at the executive level.
• Accelerate New Product Innovation: Jointly develop and execute granular, driver-based growth plans for new product innovation in partnership with Product, Product Marketing, and Sales leadership.
• Advanced Analytics and Insight Generation: Drive sophisticated, driver-based analysis, leveraging advanced quantitative methods to diagnose root causes of product performance variance and translate those findings into concrete, high-leverage strategic actions.
• Executive Influence: Deliver compelling, executive-ready presentations and expertly facilitate high-stakes discussions to secure alignment and drive critical strategic decisions with VP/SVP level functional leaders, leveraging data and strategic storytelling.
• Deep Subject Matter Expertise: Rapidly develop deep product-level and market-level subject matter expertise, becoming the go-to resource on the Identity Security landscape, the strategic shifts driven by AI, and the competitive threat vector.
• Advisory and Impact: Build and sustain deep, trusted advisory relationships with Okta’s product leadership to shape the long-term product roadmap.
• Scope and Growth: This is an individual contributor role.  It offers immediate opportunity to lead high-visibility strategic and operational initiatives across portfolio-wide planning and new product introductions.

Why this role?

• Deep exposure to product strategy development at a market leading high-growth SaaS company at the forefront of securing AI deployments in the enterprise.
• The high degree of autonomy to shape company strategy and drive impact.
• Strong executive sponsorship from Okta’s product leadership team to engage.
• Ability to take on broader responsibilities beyond strategy development over time.

Qualifications / Who You Are (Must Have)

• Minimum 7+ years of relevant work experience, with 2+ years post-MBA experience in high-impact strategy (product / corporate), top-tier management consulting, product management, growth, or investment banking roles.
• Demonstrable understanding of complex B2B SaaS business models and value drivers.
• Strategic AI Fluency: Demonstrated experience in leveraging AI tools and advanced analytics to inform strategic decision-making, with a strong, actionable perspective on the strategic implications of AI on B2B SaaS and Enterprise Security.
• Proven track record in building and sustaining trusted, executive-level advisory relationships (VP / SVP / President).
• Expertise in navigating complex, ambiguous data environments where clear data is scarce, translating complexity into clear, synthesized strategic narratives.

Qualifications / Who You Are (Good to Have)

• Experience in customer research via sophisticated quantitative and quantitative  methods.
• Deep understanding of the B2B Enterprise technology space, ideally within Enterprise Security and Identity & Access Management.
• Experience at top-tier consulting firms (McKinsey, Bain, BCG).
• An MBA from a leading program is strongly preferred.

Requires in-person onboarding and travel to our San Francisco, CA HQ office or our Chicago office during the first week of employment.

#LI-Hybrid

#LI-LSS1

requisition ID-  P24637_3360590

ABOUT THE TEAM

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

ABOUT THE JOB

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

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

WHAT YOU'LL DO

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

REQUIRED QUALIFICATIONS

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

Summary:

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

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

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

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

Reports to: Engineer I, Drug Product Process Development

Location: San Carlos, CA

Expected Contract Length: 12 months

Hourly Range: 51/hr. – 56/hr. 

Your Impact

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

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

What You’ll Do

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

Reports to: Vice President of Financial Reporting and Strategic Investments

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

What You Bring

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

Benefits that Benefit You

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

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

About this Role

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

Key Responsibilities

Laboratory Operations & Supply Chain Support

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

Analytical Testing & Sample Preparation

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

Team Collaboration

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

Basic Qualifications

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

Preferred Skills and Experience

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

Pay Range

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

Summary:

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Senior Associate Scientist (contract) with experience in microbial fermentation and upstream processing to join the Upstream Polysaccharide Process Development team. The candidate will be responsible for collaboration on experimental design and execution of experiments to further develop and optimize upstream processes for polysaccharide manufacturing using microorganisms. The successful candidate will have practical laboratory experience related to microbial fermentation processes and eager to utilize and learn new laboratory skills. The role will require >50% time in the lab and this person will be able to independently detail experimental procedures/results in written and presentation formats. The successful candidate may interface closely with the cross-functional team, write detailed technical reports, present experimental results internally, and may potentially interface with external CMO partners.

Essential Functions:

• Support in study design, execute, and analyze experiments for upstream polysaccharide for bacterial fermentation (BSL2) and vaccine production processes.
• Execute experiments to develop the upstream process parameters (e.g., media, feed, pH, temperature, dissolved oxygen, agitation, etc.) and to enhance product yield, quality, and consistency.
• Perform microbiology related work including plating, colony selection, Gram staining and cell enumeration on microscope.
• Perform fermentation vessel assembly and script writing for process automation and execute fermentation experiment in shake-flask and lab scale bioreactors.
• Prepare media and buffer as needed for experiments.
• Operate and maintain instrumentation for bacterial fermentation and primary recovery (centrifugation, filtration, etc.) of bacterial polysaccharides utilizing aseptic techniques.
• Support analytical method execution including optical density, residual metabolites and polysaccharide concentration and other relevant analytical techniques.
• Assist in executing process development studies.
• Keep accurate and current records of research and/or project related activities in laboratory notebooks and Electronic Lab Notebook.
• Prepare and review protocol, technical reports, SOPs, and batch records.
• Present and communicate scientific data and results to internal stakeholders.
• Be an outstanding teammate and collaborate effectively with cross functional team members.
• and collaborate effectively with downstream, analytical, and manufacturing teams within Polysaccharide Development and Manufacturing team to ensure seamless technology transfer and process integration.

Requirements: 

• MSc in Chemical/Biochemical Engineering, Biotechnology, or similar degree with a minimum of 3 years of relevant industry experience, or BSc with a minimum of 5 years of relevant industry experience.
• Experience in handling microorganisms with proper aseptic techniques to perform upstream processing related work in flasks/bioreactors.
• Hands-on experience and theoretical understanding of key processing operations such as microbial culture, fermentation process, microbial media, and process optimization and relevant analytical technologies; experience with depth filtration, continuous centrifugation is a plus.
• Develop and optimize scripts for instrumentation, including Ambr® systems, to enhance efficiency and automate processes, leveraging programming languages such as Python or R is a plus.
• Experience with Design of Experiments (DoE) principles and DoE software.
• Process characterization experience is a plus.
• Cell banking expertise, colony selection and genetic analysis of recombinant strains is a plus.
• Proficiency with computer programs such as Microsoft Excel, Word, PowerPoint, Visio and JMP.
• Working knowledge of GMP requirements.
• Proven ability to succeed in a cross-functional team environment, effectively managing multiple projects and contributing to team outcomes.
• Strong interpersonal skills, with excellent written and verbal communication abilities.

Co-Op – Design Engineer  
Location: Los Angeles, CA 
 Start Date: May/June 2026 (6-Month Program) 

About Maesa: 
The next gen beauty company, Maesa is transforming the industry by incubating and growing meaningful, innovative brands and making prestige beauty accessible. Maesa believes beauty ignites inspiration, creativity, imagination, and connection, sparking new ideas and possibilities, and meeting unmet consumer needs. Through best-in-class design, formulation, brand creation and marketing capabilities, Maesa delivers new, better and different products with an unsurpassed speed to market. Maesa works with a variety of retailers to create and launch brands across beauty and wellness categories. The current portfolio includes Kristin Ess, Hairitage by Mindy McKnight, Fine'ry, Being Frenshe, and Niches & Nooks among other brands. For more information, visit www.maesa.com. 

Position Overview: 
As a Design Engineer Co-Op, you’ll work alongside our Los Angeles-based team to support the design, development, and engineering of beauty product packaging. You'll gain real-world experience in turning creative design concepts into functional packaging solutions—working with a cross-functional global team from concept through to manufacturable files. 

This role is ideal for students pursuing a degree in Mechanical Engineering, Packaging Science, Product Design, or related fields and looking to gain practical experience in the cosmetics and consumer goods industries. 

This co-op position requires a full-time commitment of 40 hours per week during the Fall 2025 semester (approximately September through February) and will require to be onsite at our LA office a minimum of 4x a week. 

Key Responsibilities: 

• Support the conversion of conceptual packaging designs into engineered 3D CAD models suitable for manufacturing. 
• Assist with creating and updating SolidWorks files, 2D drawings, and visual schematics. 
• Collaborate on the evaluation of materials and manufacturing processes including injection molding, blow molding, and decoration techniques. 
• Participate in design reviews and provide input on manufacturability and product functionality. 
• Help manage prototype development and 3D printing of packaging components. 
• Work with international engineering teams and vendors to help bring designs to life. 
• Review product testing data (e.g. drop tests, vibration tests) and document feedback. 
• Contribute to project organization, timelines, and reporting. 

What You'll Gain: 

• Hands-on experience working on real packaging projects from ideation to execution 
• Exposure to engineering standards and manufacturing processes in the beauty industry 
• Opportunities to develop technical skills in CAD, design for manufacturing (DFM), and prototyping 
• Mentorship from experienced design engineers 
• Insight into product development and cross-functional collaboration 

Qualifications: 

• Currently pursuing a Bachelor's degree in Mechanical Engineering, Product Development Engineering, Product Design, or a related discipline 
• Familiarity with SolidWorks or other 3D CAD software (coursework or internship experience a plus) 
• Interest in consumer products, especially beauty or CPG packaging 
• Strong attention to detail and an eagerness to learn 
• Excellent communication and time-management skills 
• Ability to work in a fast-paced, team-oriented environment 

Compensation: 

$20/hour. Exact compensation may vary based on skills, experience, and location. 

About the Team: 

The Interplanetary Sciences Program was established to expand access to scientific exploration across our solar system. Its mission is to make planetary research faster, more affordable, and more capable than ever before by rethinking how science missions are designed, built, and operated. The program aims to enable scientists to send instruments to distant worlds without decades of development or prohibitive costs. By creating a sustainable model for interplanetary exploration, we are transforming space science from an occasional event into a continuous process of discovery that accelerates knowledge, broadens participation, and inspires the next generation of explorers.

About the Role:

We are seeking a driven science payload manager to lead the delivery, integration, and operations support for a science instrument suite. This is a highly technical role for a leader who combines deep technical and scientific competency, is confident in making risk-based decisions, and has a sense of personal ownership over the success of the instrument from build phase through on-orbit operations.

In this role you will serve as the responsible engineer for working with our partners to ensure the delivered instruments meet or exceed the desired science capability, and proceed smoothly and efficiently through environmental testing, spacecraft integration, commissioning, and in-space operations. This role requires you to understand the science and the engineering, manage risk proactively, make hard decisions under uncertainty, own the outcomes, communicate clearly to multiple stakeholders, and care deeply about the science results. You will need to understand the engineering systems and be an advocate for how they should be designed to support and enable collecting exceptional science on this and future missions. You will operate as part of a fast-moving, lean, multi-disciplinary team driven by mission success.

About You

• Master's degree in planetary science, engineering, physics, or a related technical discipline
• 3+ years experience in science research
• 3+ years experience working on a spacecraft payload through multiple phases (e.g., some combination of formulation, build, testing, integration, on-spacecraft testing, commissioning, operations)
• Relentless curiosity and a desire to understand and optimize systems
• Familiarity with Earth and planetary science missions and the unique constraints on instruments (power, mass, thermal, data rate, radiation)
• Excellent written and verbal communication skills

Nice to haves but not required

• Experience with planetary science instruments

This position may require occasional travel to partner institutions, test facilities, and mission integration sites (<10% time). During critical mission phases including launch, commissioning, and early operations this position will require shift work and on-call availability. 

Hiring Range and Leveling

Senior Engineer: 124,500 - 170,500
Staff Engineer: 150,000 - 207,000

Leveling and Compensation will be finalized after the interview process, based on an evaluation of job-related knowledge and skills, education, and experience.

We are seeking a Scientist II to join the Reagent Sustaining and Applications group to lead sustaining efforts for our Chromium Single Cell products. The role interfaces with R&D, Production, Marketing, and Support to provide the best products to our customers from pre-launch to end of life. 

The ideal candidate should have expertise in product development, troubleshooting complex issues, and understanding of molecular biology, including single cell assays, reagent manufacturing, and developing assays for quality control or manufacturing environments.

What you will be doing:

• Lead efforts in testing new materials, tools, and workflows to improve 10x’s state-of-the-art products.
• Collaborate with key internal and external partners to troubleshoot and mitigate any issues that may arise in 10x’s Chromium product line.
• Design and execute experiments to assess the impact of protocol, reagent, or process changes on 10x’s Assays.
• Perform statistical analyses on key assay and QC metrics.
• Update manufacturing documents and present results.

Minimum Qualifications:

• BS, MS, or PhD in molecular biology, biochemistry, genetics, microbiology, analytical chemistry, or related fields.
• 8+ years (BS), 5+ years (MS) or 3+ years (PhD) of relevant experience in reagent or assay development and optimization, preferably in the Biotechnology industry.
• Experience analyzing large-scale single-cell or spatial transcriptomics datasets to derive biologically meaningful insights and/or diagnostic biomarkers.
• Ability to design and execute experiments to measure the impact of process improvements and/or formulation changes.
• Experience with a broad variety of molecular biology and analytical techniques including qPCR, nucleic acid isolation, use of plate readers, Bioanalyzers, gel imagers, real-time PCR instruments, etc.
• Experience with single cell assays including cell handling, library preparation and downstream analysis.
• Experience investigating, identifying, documenting, communicating, and resolving quality control issues in a controlled manufacturing environment.
• Experience defining, documenting, communicating, and transferring new manufacturing workflows into controlled manufacturing environments.
• Meticulous attention to detail and a conscientious work ethic.

Preferred Qualifications: 

• Hands-on experience with the 10x Chromium platform.
• Experience using statistical tools, such as JMP or R to analyze complex data sets, create DOE experiments, and create data trending reports.
• Experience with bioinformatic analysis of Next Generation Sequencing data from Illumina platforms.

#LI-ES1 #LI-onsite

Position Summary

The Manufacturing Manager is responsible for the operational and strategic management of manufacturing activities including formulation, antibody conjugation, automated liquid handling–based workflows (e.g., Hamilton platforms), lyophilization, filling, and packaging in a regulated environment. This role ensures manufacturing operations are executed safely, compliantly, and efficiently while supporting both near‑term production needs and long‑term manufacturing readiness and scale, aligning with product demand and strategy defined by Operations leadership. In addition to overseeing daily manufacturing execution, the Manufacturing Manager leads manufacturing planning, capacity forecasting, and operational strategy, aligning manufacturing capabilities with product demand, technology roadmaps, and organizational growth. This role provides direct leadership to manufacturing staff, ensures personnel are trained and qualified for assigned tasks, and partners cross‑functionally with Quality, Engineering, Supply Chain, and Product Development teams to support new product and process introduction, technology transfer, validation readiness, and sustained operations.

Duties and Responsibilities

• Oversee daily manufacturing operations for reagent formulations, antibody conjugations, lyophilization, filling, and packaging.
• Ensure manufacturing documentation and records comply with GMP and ISO 13485 regulations.
• Ensure batch record review readiness and timely completion of manufacturing documentation.
• Develop and execute short‑ and mid‑term manufacturing plans aligned with demand forecasts, capacity constraints, material availability, and quality requirements.
• Lead troubleshooting for manufacturing and equipment issues; escalate appropriately and coordinate cross‑functional resolution.
• Establish and monitor manufacturing performance metrics (yield, throughput, utilization, deviations) and drive data‑based decision‑making.
• Forecast manufacturing capacity (equipment, staffing, consumables) and recommend actions to support growth and product roadmap needs.
• Drive process optimization to improve yield, cycle time, robustness, and quality.
• Partner with Operations leadership to support manufacturing strategy initiatives, including automation adoption, scale‑up planning, and operational readiness.
• Partner cross‑functionally with internal teams to support technology transfer, scale‑up, and production launch.
• Lead Manufacturing participation in new product introduction (NPI) and new process introduction (PPI) to ensure manufacturing readiness from development through routine production.
• Identify training needs, ensure training plans are created and executed, and maintain qualification readiness per ISO 13485 requirements.
• Provide regular coaching, performance feedback, and development support for Manufacturing staff.
• Maintain manufacturing areas in an organized, controlled, and inspection‑ready state; enforce safe work practices and compliance expectations.
• Support internal and external audits and regulatory inspections; maintain a continuous inspection‑ready posture.
• Ensure execution of cycle counts and inventory controls; resolve discrepancies and implement preventative measures.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemical engineering, or related field OR equivalent combination of education and progressive manufacturing leadership experience.
• 10+ years experience in regulated manufacturing (biotech, pharma, medical device, diagnostics), including 3+ years in a supervisory or management role.
• Demonstrated experience across formulation, filling/packaging/labeling, antibody conjugation, automated liquid handling platforms (e.g., Hamilton), and lyophilization
• Strong working knowledge of GMP and ISO 13485.
• Experience leading cross‑functional initiatives supporting NPI/PPI or technology transfer.
• Proven leadership, problem‑solving, and communication skills.

Preferred Qualifications

• Hands‑on familiarity with process characterization, scale‑up, and validation readiness activities (e.g., support of IQ/OQ/PQ planning or execution).
• Practical experience driving or supporting continuous improvement initiatives within a manufacturing or operations organization.
• Experience implementing or supporting automation and digital manufacturing tools, including ERP, MES, or electronic batch record systems.
• Demonstrated ability to lead cross‑functional teams by influence, aligning Manufacturing, Quality, Engineering, and Supply Chain toward shared objectives.

Physical Requirement:

• Ability to lift up to 25 lbs.
• Periodic presence on the manufacturing floor, including extended standing or walking as required.

The base salary range for this full-time position is $140,000 - $160,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process. 

The Opportunity:

Revolution Medicines is seeking Scientist II to join the Drug Product team within Pharmaceutical Development & Manufacturing (PDM). This role will support the development of solid oral dosage forms for small molecule programs across the RVMD pipeline.

The successful candidate will contribute to formulation and process development activities from early-stage through late-stage clinical/commercial development, working closely with cross-functional partners and CDMOs to ensure robust, scalable, and compliant drug product manufacturing processes.

Key Responsibilities:

• Contribute to drug product development activities for new chemical entities (NCEs) from early development through late-stage clinical development, with exposure to commercialization activities.

• Design and execute drug product development and manufacturing activities for solid oral dosage forms, including:

  • Preformulation and formulation development.

  • Manufacturing process development.

  • Process scale-up, technology transfer, and process optimization.

  • Process validation and commercial manufacturing support.

• Support outsourced development and GMP drug product manufacturing activities at CDMOs including manufacturing oversight and troubleshooting.

• Design and execute experiments, analyze and interpret data and present results and conclusions to project teams.

• Work independently with limited supervision to conduct appropriate research and troubleshoot technical challenges, escalating complex issues as needed.

• Author and contribute to CMC documentation for regulatory submissions (e.g., INDs, NDAs, MAAs) and internal technical reports.

• Collaborate cross-functionally within CMC team (Clinical Supply, Analytical Development/QC, Quality Assurance, Drug Substance, Regulatory Affairs, and Project Management) and at enterprise level research/clinical/commercial teams to support aligned development strategy and execution.

• Travel up to 20% to CRO/CDMO sites to support and oversee development and manufacturing operations.

Required Skills, Experience and Education:

• A degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

• Ph.D. with minimum of 3+ years of experience or a bachelor’s/master’s degree with appropriate experience in the pharmaceutical/biotech industry settings.

• Experience supporting drug product development and manufacturing for small molecules.

• Demonstrated experience in solid oral dosage formulation and process development for small molecules.

• Experience working with external partners (CDMOs/CROs) and overseeing outsourced development and manufacturing activities.

• Working knowledge of global regulatory expectations, including ICH guidelines and FDA, EMA, PMDA etc. requirements.

• Experience contributing to CMC regulatory filings is desirable.

• Strong technical writing, communication, and problem-solving skills.

• Ability to manage multiple priorities and thrive in a fast-paced, innovation-driven collaborative environment.

Preferred Skills:

• Ph.D. degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable. 

  #LI-Hybrid #LI-CT1

The Opportunity:

Playing a critical role within CMC function, as Senior Scientist I, Analytical Development the position will support the manufacturing and control of drug substances and drug products during clinical development. The position will provide analytical support to API process research and development, formulation development, and assist in regulatory filings in support of Revolution Medicines pipeline compound development and clinical programs.

Specifically, you will be responsible for:

• Provide support and oversight to analytical development activities, such as method development, method validation and testing, at contract partner sites to ensure outsourced activities are executed successfully and meet the objectives.

• Provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings.

• Critically review data packages associated with method validations, release testing, and other characterization testing for drug substances and drug products.

• Collaborate with cross functional teams in the establishment of control strategy and setting specifications for drug substances and drug products.

• Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document.

• Communicate technical findings to colleagues and collaborators within formal and informal settings, including cross-functional project team meetings.

• Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.

• Present work and results in team and group meetings.

Required Skills, Experience and Education:

• Ph.D. with a min of 5 years industry experience or MS degree with a min of 8 years of relevant industrial experience in analytical development.

• Technical knowledge of analytical technologies including HPLC/UPLC, XRPD, LCMS, DSC, DVS and Dissolution.

• Experience managing projects at CROs/CDMOs.

• Experience with analytical method development, validation and method transfer.

• Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).

• Knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.

• Strong problem-solving skills with sound technically driven decision-making ability.

• Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

Preferred Skills:

• PhD or MS in analytical chemistry, organic chemistry, or related discipline.

• CMC experience with small Molecules is strongly desired, and experience in solid oral dosage is a plus.

• Familiarity with document management systems (such as Veeva or similar). #LI-Hybrid #LI-CT1

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally, collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities
 

• Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team, late-stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

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

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel to domestic and international locations is required.

#LI-HYBRID #NC1 

About the Role

Reporting to the Sr. Director, Pharmaceutical Sciences, the Associate Director, Pharmaceutical Sciences (Drug Delivery) will lead and execute innovative drug delivery and formulation strategies to support pre-IND product development, candidate selection, and novel delivery platform advancement. The incumbent will drive scientific and technical direction for formulation & delivery approaches across modalities, strengthen the company’s IP portfolio, and collaborate with cross-functional teams (Innovation Lab, Translational Sciences, Pharmaceutical Development, Analytical Development) to enable successful transition from concept to candidate selection.

Let’s talk about some of the key responsibilities of the role:

• Develop and lead delivery sciences strategy for new and emerging modalities (small molecules, biologics, peptides)
• Identify white space opportunities and contribute to invention disclosures and patent strategy in partnership with IP counsel.
• Evaluate competitive landscape and emerging delivery technologies to inform internal innovation strategy.
• Design, execute, interpret laboratory results to develop and optimize novel drug delivery systems, and define data-driven next steps to drive platform development.
• Generate formulation and delivery approaches to enable pre-clinical animal models.
• With the Translational Sciences team interpret in vitro and in vivo data (PK/PD, bio-distribution, tolerability) to refine and prioritize delivery strategies.
• Represent delivery sciences in program governance and external partnerships.
• Serve as scientific lead for external CRO partnerships.
• R&D project budget planning and budget management.
• May perform other related duties as required and/or assigned.

Factors for Success:

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biomedical Engineering, or related field.
• Minimum of 8 years of relevant experience in drug delivery and developing novel drug delivery platforms from concept through preclinical validation.
• Experience managing CROs and external research collaborations.
• Strong experimental design, data interpretation, and problem-solving skills.
• Track record of platform innovation and contribution to patents in drug delivery.
• Excellent communication skills with ability to present complex technical concepts clearly to diverse stakeholders.
• Strong leadership skills and experience in cross-functional project leadership.
• Tarsus Competencies:
  • Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
  • Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
  • Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

 A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Sr. Director, Pharmaceutical Sciences.
• Some travel may be required – up to 20%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $150,000 - $210,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Hybrid

Position

The Associate Director, CMC Drug Product will lead drug product development and clinical manufacturing activities across multiple programs, with a strong focus on early- to mid-stage small-molecule oral solid dose compounds. This individual will be responsible for defining and executing drug product strategies from preclinical development through clinical supply, while ensuring compliance with global regulatory requirements. In this role, you will serve as the primary drug product CMC lead, partnering closely with internal cross-functional teams and external CDMOs to advance the company’s pipeline. The ideal candidate brings deep technical expertise in formulation and process development, strong project leadership skills, and hands-on experience supporting regulatory submissions for early clinical programs.

About You

You are a drug product CMC leader with a strong foundation in pharmaceutical sciences and a proven track record advancing small-molecule oral solid dose programs in a fast-paced biotech environment. You are comfortable owning drug product strategy end-to-end, from preformulation and formulation development through clinical manufacturing and packaging, with particular strength in early-stage development. You thrive in cross-functional settings and are experienced working with CDMOs to deliver phase-appropriate formulations, leveraging solid dose processing technologies such as spray drying and compression. You bring a clear understanding of regulatory expectations for early and mid-stage programs and can translate technical development work into high-quality CMC documentation. You are hands-on when needed, detail-oriented, and proactive in identifying risks, driving solutions, and keeping programs on track.

What You’ll Do

• Lead the preclinical formulation development and drug product development from early clinical through commercial stages
• Oversee formulation development and scale-up activities at CDMOs
• Ensure robust and scalable manufacturing processes are in place  
• Collaborate with cross-functional teams including Research Project Teams, Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain and Clinical Operations to ensure seamless product development delivery
• Develop and execute project plans, timelines, and budgets
• Ensure all CMC activities comply with regulatory requirements (FDA, EMA, etc.)
• Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, CTDs, etc.
• Interact with regulatory agencies to address CMC-related queries and provide necessary documentation 
• Mentor and develop junior staff members 
• Identify and manage external partners, including CMOs and CROs
• Ensure quality and timely delivery of contracted services
• Negotiate contracts and manage vendor performance 
• Potential to contribute to setting up new, in-house non-GMP formulation laboratory

Qualifications

• A Master’s degree in Pharmaceutics, Chemical Engineering, or a related field with 8+ years of experience in pharmaceutical formulation and drug product development, or a PhD with 6+ years of experience in pharmaceutical formulation and drug product development
• Experience with development of various dosage forms (solid oral, injectable, etc.) and different manufacturing processes (compression, SDD, etc.)
• Previous experience serving as a drug product lead though IND and/or NDA stages
• Proven track record of successful FIH formulation development and regulatory submissions
• Strong understanding of FDA and EMA regulatory requirements and quality systems
• Excellent communication, leadership, and problem-solving skills with hands-on knowledge of cGMPs and quality control processes 
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities
• Excellent interpersonal and communication skills, capable of leading and motivating teams

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $174,000 to $190,000 depending on skills, competency, and the market demand for your expertise.

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

We are actively seeking qualified candidates to join our talent pipeline for future client engagements.  

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

Summary:

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is seeking an Associate Engineer II with experience or strong foundational knowledge in vaccine or biologics process development and manufacturing to join the Polysaccharide Clinical Manufacturing/Process Development team.

The candidate will provide technical support for manufacturing activities in collaboration with CDMO partners, while also contributing to process development and process validation efforts. The position requires laboratory presence (>50%) and the ability to independently execute and document experiments, analyze data, and communicate results through technical reports and presentations. The successful candidate will collaborate cross-functionally and may interface with external CDMO partners to support manufacturing campaigns and process transfers.

Essential Functions:

• Provide remote manufacturing (MFG) oversight to support batch execution, ensuring adherence to process parameters and GMP requirements
• Participate in deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
• Provide technical support for MFG and process development through data analysis, MFG document reviews, and supporting lab scale studies
• Perform in-process sample testing to support monitoring of MFG process performance and understanding
• Manage sample inventory, including tracking, storage, and organization of manufacturing samples
• Maintain accurate and timely documentation in electronic lab notebook (ELN) systems
• Analyze manufacturing and experimental data using statistical tools (e.g., JMP) and summarize findings in technical reports
• Collaborate with cross-functional teams including Process Development, Manufacturing, Analytical Development, and Quality
• Prepare and present technical data to internal stakeholders and support interactions with CDMO partners

Requirements: 

• BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
• Experience or exposure to GMP manufacturing environments and process development activities
• Hands-on experience with in-process analytical techniques, including colorimetric and enzymatic assays
• Familiarity with upstream and downstream processing technologies, such as fermentation, UF/DF, depth filtration, and chromatography
• Experience supporting technology transfer, scale-up, or CDMO-based manufacturing is preferred
• Understanding of deviation investigations and root cause analysis methodologies
• Familiarity with statistical analysis tools (e.g., JMP) is preferred
• Experience using electronic lab notebook (ELN) systems is a plus
• Strong technical writing, data analysis, and communication skills

Role

As an Applied Scientist (ML) at Samaya, you will collaborate closely with our product and engineering teams, and use cutting-edge ML research to transform how users interact with Samaya in their daily workflows. You'll drive impact across the entire ML lifecycle: from problem formulation and system analysis to data collection, benchmark development, model training, and production deployment. You’ll also have opportunities to publish your work and deliver impact to the ML community. Your expertise will advance our capabilities in these critical technical domains:

• Retrieval, ranking and RAG
• LLM post-training and reinforcement learning
• AI agents for knowledge workflows
• ML benchmarks

Your work has the potential to transform the following key Samaya products and deliver impacts to tens of thousands of professional users:

Instant QA: Our custom-built Question Answer system using state of the art in house models, seamlessly trained to work together to enable instant expert intelligence.

Agents: You will enable expert-level agentic workflows to automate comprehensive knowledge work and enable AI tools that work with experts to gain new insights.

You can read some of our previous ML work at: https://samaya.ai/blog/ and https://samaya.ai/research/.

Responsibilities

• Formulate an ML problem from product requirements
• Analyze existing ML systems for their limitations, and propose and validate novel methodologies to improve upon existing systems
• Create and productionize cutting-edge research prototypes for knowledge work at scale
• Build novel ML evaluation datasets that serve as crucial criteria for production feature rollouts
• [Optionally] Mentor ML interns and publish your research findings with the community

Experience

Required

• PhD or Master’s degree in Computer Science, Machine Learning, NLP, or a related field
• Strong background in deep learning, large language models, and NLP techniques
• A strong track record of first-author publications in top AI/NLP conferences (e.g., NeurIPS, ICML, ACL, EMNLP)
• Proficiency in Python and deep learning frameworks such as PyTorch or Transformers, and strong coding skills

Preferred

• 2+ years of experience in an industry applied ML research environment
• Familiarity with retrieval-augmented generation, reasoning, LLM training and reinforcement learning techniques

Compensation

The cash compensation range for this role is $190,000 - $275,000.

Final offer amounts are determined by multiple factors, including experience and expertise, and may vary from the amounts listed above.

In addition to the base salary, we may consider equity as part of our total compensation package.

Benefits

Health: Access comprehensive health insurance, including medical, dental, vision, flexible spending account (FSA), and short-term disability.

Wealth: Support for your long-term financial wellbeing with a 401(k) and pre-tax benefits (e.g. commuting).

Rest: Enjoy flexibility to rest and recharge as needed, with unlimited PTO (Paid Time Off).

Flexibility: Work flexibly with a hybrid setup - typically team members spend a minimum of three days in the office per week.

Travel: Grow and connect with a travel budget that encourages conference attendance, customer visits, and team gatherings.

Equipment: Create your ideal workspace with an office Equipment allowance to set up what works best for you.

About This Role

Our pharmaceutical team is looking for a highly motivated Senior Scientist to lead protein formulation development programs within our Biologics Formulation team. This role offers the opportunity to pioneer innovative formulation strategies for high concentration biologics and advanced systems while building capabilities in a dynamic startup environment.

As a Senior Scientist, you will lead the design and execution of complex formulation development programs, applying deep expertise in protein chemistry and physical biochemistry to solve challenging formulation problems. You will drive strategic decisions in formulation design, mentor junior scientists, and establish best practices for formulation development in a fast-paced startup setting.

Responsibilities

Strategic Formulation Development

• Lead formulation development programs for high concentration protein therapeutics across dosage forms
• Design and execute formulation strategies based on first-principles understanding of protein chemistry, including solution behavior, protein-protein interactions, and colloidal stability
• Develop advanced formulation platforms
• Apply thermodynamic and kinetic principles to predict and optimize formulation behavior
• Identify and mitigate formulation-related risks including aggregation, precipitation, viscosity, chemical degradation 
• Identify Critical Quality Attributes

Technical Leadership & Innovation

• Serve as technical lead on multiple concurrent formulation projects from early-stage through late-stage development
• Design experimental strategies and interpret complex datasets to drive formulation decisions
• Establish formulation development workflows, analytical strategies, and acceptance criteria 
• Evaluate and implement novel formulation technologies and approaches
• Interface with cross-functional teams including analytical development, engineering, and external partners

Team Development & Data Excellence

• Mentor and provide technical guidance to junior scientists
• Establish robust data management practices and quality standards
• Maintain exemplary ELN documentation and ensure data integrity across the team
• Author technical reports, regulatory submissions, and scientific publications
• Deliver high-quality results within aggressive startup timelines while maintaining scientific rigor

Basic Qualifications

• PhD in Pharmaceutical Sciences, Biomaterials, Materials Science, Chemistry, Chemical Engineering, Biochemistry, or related discipline
• 3+ years of biopharmaceutical industry experience in early-stage or late-stage protein formulation development
  Proven track record of leading formulation development projects from concept through execution
• Deep expertise in protein chemistry, physical biochemistry, and formulation science
• Extensive hands-on experience with analytical techniques for protein characterization (e.g., DLS, DSF, SEC, CE, rheology, spectroscopy)
• Experience developing high-concentration protein formulations and mitigating concentration-limiting factors
• Strong foundation in thermodynamics, solution chemistry, and colloidal science as applied to protein systems
• Demonstrated ability to work independently in fast-paced environments with shifting priorities 
• Excellent organizational skills with meticulous attention to data management and ELN practices Strong scientific writing and presentation skills

Preferred Skills And Experience

• Experience with protein crystallization, for drug delivery
• Knowledge of advanced formulation systems
• Experience with lyophilization, spray drying, or other solid-state processing unit operations
• Familiarity with Design of Experiments (DOE) and statistical analysis approaches
• Experience with high-throughput formulation screening and automation
• Track record of scientific publications or patent applications 
• Experience in startup or resource-constrained R&D environments
• Background in monoclonal antibodies, antibody-drug conjugates, or other complex biologics

What We Offer

• Opportunity to pioneer formulation development for space-based biomanufacturing
• Technical leadership role with significant scientific autonomy
• Collaborative environment working alongside world-class scientists and engineers
• Opportunity to shape the scientific direction of a growing company

Pay Range

• Salary Range: $140,000.00 - $180,000.00/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for long-term incentives in the form of stock options and/or long-term cash awards

What You Will Contribute To Altos

The Altos Institute of Medicine will capture knowledge generated about cell health and programming and develop transformative medicines. We are seeking an experienced Scientist, Formulation Development, to join the Technical Operations team within the Institute of Medicine for a six month contract. The candidate will work in a highly dynamic and cross-functional environment that will have close collaboration with the Institutes of Science and span multiple therapeutic areas. The successful candidate will perform formulation development for Altos’ small molecule and oligonucleotide programs.

Responsibilities

• Conduct formulation, process development and manufacturing for small molecule and oligonucleotide therapeutics, and support drug product development for other modalities
• Perform preformulation characterization and analytical testing to support drug product development
• Support development and manufacturing at Contract Development and Manufacturing Organizations (CDMOs) to deliver products for nonclinical studies and clinical trials 
• Perform troubleshooting and data analysis to solve technical problems in formulation development and manufacturing to ensure product quality
• Support risk assessments and manufacturing deviation investigations
• Author Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
• Foster strong partnerships with Institutes of Science and development sciences
• Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion

Who You Are 

Qualifications

• M.S. with 6+ years or Ph.D. with 2+ years of experience in the formulation, process development, and manufacturing of small molecule drug products, with a degree in chemistry, pharmaceutical sciences, chemical engineering, or a related field.
• Experience in preformulation characterization and analytical testing
• Experienced in achieving CMC deliverables through outsourcing to CDMOs is preferred
• Ability to work in a dynamic environment, with a willingness to learn new skills and adapt to shifting priorities and tasks
• A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a big-picture innovator who can identify opportunities and is comfortable with ambiguity
• Strong communication and collaboration skills. Build effective relationships and partnerships with internal and external stakeholders

The salary range for Redwood City, CA:

• Scientist I, Formulation Development: $61/hr. - $75/hr.
• Scientist II, Formulation Development: $72/hr. - $88/hr.

Exact compensation may vary based on skills, experience, and location.

For UK applicants, before submitting your application:

- Please click here to read the Altos Labs EU and UK Applicant Privacy Notice (bit.ly/eu_uk_privacy_notice)
- This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.

Summary:

Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate must have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, especially immunoassays and multiplexed immunoassay formats. Experience in analyzing vaccine and adjuvant-containing formulations is a plus.

In addition, Vaxcyte is looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a lab-based scientific role and requires excellent scientific judgement, independence, rigor, and thorough record-keeping.

Essential Functions:

• Execute routine and non-routine analysis of internal release, development, and stability samples using a variety of analytical techniques across Drug Product working groups, ensuring high-quality data generation and reporting.
• Support the execution, optimization, and continuous improvement of Vaxcyte’s internal multiplex immunoassay (MSD) assay suite, including troubleshooting assay performance, improving robustness, and supporting assay lifecycle management.
• Design, execute, and interpret experiments to support non-GxP stability studies including thermal, freeze/thaw, agitation, and container closure system evaluations for both Drug Substance and adjuvanted vaccine Drug Product materials.
• Analyze and interpret complex assay data, identify trends or deviations, and communicate findings to project teams to support development decisions.
• Contribute to method development, qualification, and technology transfer activities, including collaboration with external analytical laboratories and manufacturing CMOs.
• Author and review technical documentation including assay protocols, SOPs, reports, study plans, and technical summaries in support of development and analytical activities.
• Support the Vaxcyte PCV and VAXA1 programs through cross-functional collaboration with Drug Product Development, Formulation, Analytical Development, Quality, and external partners.
• Vaxcyte is seeking a flexible and collaborative Scientist comfortable managing multiple priorities in a fast-paced development environment.
• This role is predominantly lab-based and requires strong scientific judgment, independence in experimental execution, rigor in data analysis, and meticulous record keeping.

Requirements: 

• MS degree in Chemistry, Biochemistry, or related field with minimum 5 years of relevant industry experience, or BS degree with minimum 8 years of relevant industry experience.
• At least 2 years of experience in an analytical development or quality control role.
• Prior experience running colorimetric assays is required.
• Prior experience with SEC-MALS is required.
• Prior experience with SDS-PAGE is required.
• Excellent attention to detail, organizational skills, and record-keeping abilities.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Commitment to integrity, professionalism, and safety in all aspects of work.

Hourly Range: $62.00/hr. - $68.00/hr.

About the Role:

Dr. Squatch is seeking a Corporate Quality Manager to lead and maintain the company’s Quality Management System (QMS), ensuring all products meet internal quality standards and regulatory requirements. This role partners cross-functionally with Product Development, Operations, Supply Chain, Regulatory, and external manufacturing partners to ensure consistent product quality throughout the product lifecycle, from raw material sourcing through manufacturing, distribution, and post-market monitoring.

This role will report to the Sr. Director of Quality & Regulatory Compliance. 

This is a full-time, hybrid role with company benefits based in Marina del Rey, CA.

The anticipated base compensation range for this role will be $100,000 to $120,000. Compensation will be commensurate with the candidate's experience and local market rates.

What You'll Do:

• Quality Management System (QMS) Leadership
  • Own and continuously improve the corporate Quality Management System, including document control, deviations, CAPAs, change management, training, and quality risk management.
  • Write, implement, and maintain SOPs, work instructions, templates, and quality policies across the product lifecycle.
  • Ensure quality systems meet FDA, ISO, and internal standards for traceability, data integrity, and risk management.
  • Own and administer the corporate change control process, ensuring proper documentation, effectiveness tracking, and closure
• GMP Compliance & Regulatory Partnership
  • Ensure ongoing compliance with applicable regulations and standards including FDA 21 CFR Parts 210 & 211, 21 CFR 111, ISO 22716, and cGMP requirements.
  • Support preparation for and participation in internal audits, third-party audits, and regulatory inspections.
  • Oversee internal audit programs and ensure timely closure of audit findings and CAPAs.
  • Review and approve Certificates of Analysis (CoAs) and support batch record release when required.
  • Partner with Regulatory and Product Development teams to ensure quality considerations are integrated early in formulation, scale-up, and commercialization activities.
• Supplier & Manufacturing Quality Oversight
  • Work cross-functionally to ensure suppliers, vendors, and manufacturing partners understand and meet company quality standards.
  • Support supplier qualification programs, audits, and ongoing performance monitoring.
  • Review and approve laboratory data, test results, investigations, deviations, and product disposition decisions from manufacturing partners.
  • Ensure laboratory operations align with GMPs, validated methods, and regulatory expectations.
• Product Quality & Risk Management
  • Investigate and resolve non-conformances, deviations, change control requests, and severe adverse events associated with products or processes.
  • Lead root cause analysis and implement effective corrective and preventive actions (CAPAs).
  • Oversee complaint investigations and ensure timely and compliant resolution of escalated consumer complaints.
  • Track and analyze quality metrics and trends to identify systemic issues and implement sustainable improvements.
• Inventory Quality & Product Disposition
  • Provide guidance on disposition of damaged, expired, out-of-specification, excess, or obsolete raw materials, components, and finished goods.
  • Oversee inspection, rework, relabeling, repacking, returns, or disposal activities when required.
  • Ensure branded product destruction is conducted safely, economically, and discreetly while preventing diversion, resale, or unauthorized exposure.
  • Maintain documentation for all disposition and destruction activities.
• Cross-Functional Collaboration
  • Partner with Operations, R&D/Product Development, Procurement, Engineering, and Supply Chain to support:
    • New product launches
    • Process validation and manufacturing changes
    • Raw material changes and supplier updates
    • Stability and shelf-life programs
  • Develop quality standards and acceptable product specifications in collaboration with Production, R&D/PD, and Packaging teams.
• Continuous Improvement & Quality Leadership
  • Track, analyze, and report quality KPIs and trends to leadership.
  • Drive continuous improvement initiatives that strengthen compliance, operational efficiency, and inspection readiness.
  • Train and mentor internal teams and external partners on SOPs, GMPs, and quality expectations.
  • Serve as a quality authority responsible for product disposition decisions, risk acceptance, and compliance escalation.
  • Ensure products are produced, stored, transported, and distributed in accordance with established quality standards and operating procedures.

About You:

• Education & Experience
  • Bachelor’s degree in a scientific or technical discipline (e.g., Chemistry, Biology, Microbiology, Chemical Engineering, or related field).
  • Minimum 5+ years of experience in Quality Assurance, Quality Control, or Quality Systems within cosmetic and/or OTC drug manufacturing.
  • 3+ years of leadership or supervisory experience, with demonstrated ability to manage teams and influence cross-functional stakeholders.
  • Experience working with contract manufacturers and global suppliers in regulated environments.
• Skills & Competencies
  • Strong knowledge of FDA regulations, ISO 22716, and current Good Manufacturing Practices (cGMP).
  • Experience with quality systems and electronic Quality Management Systems (eQMS).
  • Proven ability to lead investigations, root cause analysis, CAPA management, and quality risk assessments.
  • Strong communication skills with experience presenting quality metrics and risk assessments to leadership.
  • Strategic mindset with the ability to balance compliance, operational efficiency, and business priorities.

#LI-TC1 #LI-HYBRID #LI-FULLTIME

THE ROLE 

The R&D Manager, Brand Maintenance & Productivity is responsible for maintaining the integrity, quality, and efficiency of the existing beverage portfolio. This role leads formula stewardship, cost optimization initiatives, and technical execution of brand maintenance projects. The position is a hands-on technical leadership role that manages a team of R&D Scientists or Technicians while actively contributing to formulation, experimentation, and plant trial execution. This role works cross-functionally with Procurement, Quality, Regulatory, and Supply Chain teams to ensure the portfolio remains consistent, scalable, and optimized for both sensory performance and operational efficiency. 

RESPONSIBILITIES  

Brand Maintenance & Formula Stewardship 

• In collaboration with Quality and Regulatory departments, own technical stewardship of the existing beverage portfolio, ensuring formulas remain consistent, compliant, and scalable across manufacturing locations. 

• Manage formula and specification updates related to ingredient changes, supplier transitions, regulatory updates, process improvements, and ongoing specification refinement based on production learnings ensuring all changes are clearly communicated, reviewed, and aligned with manufacturing partners for accuracy and execution readiness. 

• Evaluate and mitigate potential risks to product quality, sensory, or manufacturability when changes are introduced. 

 
Productivity, Cost Optimization & Supply Continuity 

• Identify and lead cost savings initiatives across the portfolio, including ingredient optimization, supplier qualifications, and specification improvements. 

• Partner with Procurement to validate alternative suppliers and ingredients. 

• Own ingredient and formula specification R&D technical approvals. 

• Conduct technical assessments to ensure cost improvements do not negatively impact sensory quality, product stability, or processability. 

• Develop technical justification, validation plans, and implementation strategies for productivity initiatives. 
   

Sensory Validation & Technical Problem Solving 

• Design and execute sensory evaluation protocols to validate formula, ingredient, and process changes across the existing portfolio.  

• In collaboration with Quality, investigate product performance issues including sensory deviations, shelf-life concerns, and process variability. Design and execute experiments to identify root causes and implement corrective actions.  

• Interpret sensory, analytical, and process data to inform technical decisions and risk assessments.  

• Document findings, conclusions, and recommendations to support cross-functional decision-making and leadership updates. 
   

Commercialization & Manufacturing Support 

• Lead plant trials related to brand maintenance, formula renovations, and productivity projects. Develop protocols, success criteria, and post-trial reporting documentation with clear technical recommendations. 

• Translate bench-scale formulations into scalable manufacturing processes and support troubleshooting during scale-up. 

• Serve as key R&D technical contact for manufacturing plants during process, formula, or specification updates. 

Team Leadership  

• Directly manage a team of R&D Scientists, providing guidance on experimental design, data interpretation, and project prioritization. 

• Balance hands-on technical contribution with effective delegation to ensure efficient project execution. 

• Support technical skill development in areas such as formulation, commercialization, sensory evaluation, and manufacturing support. 
   

QUALIFICATIONS: 

• 6–8+ years of product development in the food and beverage industry. Experience with carbonated beverages strongly preferred. 

• 0-2 years of experience managing and developing technical team members. 

• Bachelor’s degree in Food Science or a related field. 

• Excellent mathematical and analytical skills 

• ​​Proven experience supporting commercialization and plant-scale manufacturing. 

• Familiarity with regulatory requirements and quality standards in the beverage industry. 

• Excellent problem-solving skills and ability to troubleshoot technical issues. 

• Strong project management skills and ability to handle multiple projects simultaneously. 

• Experience with ingredient supplier qualification and cost optimization. 
• Effective communication and teamwork skills. 
• 25-40% travel to manufacturing plants, suppliers, and team offsites 
• Close proximity to our lab in Burlingame. Ability to work onsite 4 days a week. 

REPORTS TO: 

Sr. R&D Manager

COMPENSATION:

$110,000 - $130,000

This role is a hybrid position, coming into the office (Encino, CA) 4x week. 

About Us

At Zevia, we’re creating a world of better-for-you flavor—better for people and the planet. Our team is made up of courageous challengers and tenacious builders who are passionate about our mission. We’re solutions-oriented, always improving, and we operate with a healthy thirst for risk. We believe in staying true to our convictions while continuously learning and evolving.

At our core, we are people-centric. We care deeply, lead with empathy, and operate as one team—no egos, just a shared purpose. We strive to reflect the diversity of our consumer base within our organization and foster a culture of empathy and humility.

Together, we aim to impact global health, provide affordable better-for-you products, and protect the planet by reducing plastic.

We’re fighting the good fight to change the beverage industry for the better — and we’re just getting started.

Summary 

The Manager, Product Development plays a key leadership role in shaping the future of Zevia’s portfolio. This role will shape how new products come to life and how existing products continue to evolve – bringing together creativity, technical rigor, and cross-functional partnership to turn ideas into scalable, market-ready solutions. Operating at the intersection of innovation, science, and execution, this role helps craft the next chapter of Zevia’s product development work while advancing our commitment to better-for-you beverages.

What You’ll Do 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Identify white space opportunities – including emerging trends – within the beverage category and develop innovation concepts informed by consumer insights, market data, the evolving ingredient landscape, and business needs
• Lead all aspects of product development to conceptualize, design, and develop new products, translating product briefs into great tasting, scalable formulations that meet cost targets
• Apply deep experience working with stevia‑sweetened formulations to inform formulation decisions and product optimization
• Evaluate existing flavor lineup for opportunities to enhance taste and improve costs
• Conduct benchtop trials to assess solubility, dispersion, flavor delivery, and shelf-life indicators
• Apply iterative testing and refinement to improve product performance across storage and distribution conditions
• Collaborate cross-functionally throughout the innovation process to ensure that all projects stay on strategy, on budget, and on time
• Support scale-up and commercialization processes at co-pack facilities

What We're Looking For

• Bachelor’s degree in Food Science or a related scientific discipline
• 5+ years of experience in the beverage industry with product development and regulatory responsibilities
• Demonstrated experience formulating with stevia and qualification as a trained stevia taster, with the ability to evaluate sweetness, bitterness, and overall sensory impact across liquid applications
• Experience working within structured Stage Gate or NPD processes
• Working knowledge of FDA regulations and ingredient compliance
• Experience developing talent, leading teams, and managing cross-functional relationships
• Familiarity with food and beverage laboratory SOPs, safety, and GLP protocols
• Familiar with scientific principles in beverage and ingredient development, including sweetener systems
• Regulatory background and experience with current FDA standards
• Hands on experience with Operations or Mechanical processes
• Experience managing vendor partners
• Excellent communication skills and ability to distill complex data into clear and actionable narratives

Supervisory Responsibility

This position does have direct supervisory responsibility. 

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers, filing cabinets, and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 30 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. 

Position Type/Expected Hours of Work

Full-Time Exempt

Travel

This position may require ad hoc travel, per business need.

Work Authorization/Security Clearance

Must be eligible to work in the U.S.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

What We Offer

• A collaborative environment, where everyone contributes and delivers
• A place where you can grow, develop and learn
• Competitive compensation that includes a base salary, discretionary bonus and stock options. See below for range.
• A comprehensive benefits package which includes:
  • An array of medical plans
  • Dental
  • Vision
  • Group Life Insurance
  • Short-term disability + Long-term disability
  • Flexible Spending Accounts: Medical, Dependent and Limited Use
  • Health Savings Account
  • Accident Insurance
  • Critical Illness Insurance
  • Hospital Indemnity Insurance
  • Legal Insurance
  • Travel Assistance
  • Employee Assistance Program
  • Pet Insurance
  • 401k Plan (Traditional and Roth)
  • Vacation, Personal/Sick Days, and Holidays
  • Professional development contributions
  • And of course, all the Zevia you can drink!

THE ROLE

We are seeking an experienced and highly motivated Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug discovery and development programs. Reporting to the Vice President, CMC, this individual will fill a critical role as the subject matter expert (SME) and functional lead and will contribute to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities. This position is instrumental in collaborating with and managing a network of consultants and Contract Development and Manufacturing Organization (CDMO) partners to enable our efforts to discover and develop small molecule therapeutics.

Responsibilities

• Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry, form and formulation development, and GMP manufacture.
• Define CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product in alignment with industry standards and regulatory expectations.
• Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability of drug substance and drug product.
• Author and review analytical methods, protocols, reports, batch records, change controls, corrective and preventative actions, deviations, and investigation, including OOS and OOT events.
• Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and the supporting technical documents and remain current on Health Authority guidance and expectations.
• Develop CMC strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals.
• Develop and maintain the quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
• Establish and manage a reference standard program, including oversight of qualification and maintenance of reference standards at CDMOs.
• Support the evaluation, selection, and management of CDMOs to perform process and method development, and GMP manufacture, release testing, and stability studies.
• Represent CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supplies and achieve project goals.

Qualifications

• A BS, MS, or PhD degree in analytical chemistry or related field with a minimum of 16 years, 14 years, or 10 years, respectively, of relevant industry experience with demonstrated increasing responsibilities within analytical development.
• Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GLP and IND-enabling material supplies, through GMP clinical trial supplies and commercialization.
• Demonstrated expertise with analytical method development, phase appropriate method qualification/validation, release and stability testing, and specification development and justification.
• Experience with analytical techniques for small molecules and oral solid dose products. Must demonstrate a strong proficiency in IR, UPLC/HPLC, LC/GC-MS, KF, GC, dissolution, ICP, and microbial limit tests. Must have proficient working knowledge of NMR and solid-state characterization techniques such as particle size distribution and XRPD.
• Strong quality mindset and effective leadership of quality systems, including SOPs, protocols and reports, release and stability data review, OOT and OOS management, Good Documentation Practices, LIMS and cGMP data traceability, Deviations, and Change Management.
• Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
• Proven ability to manage and collaborate with external partners, including consultants and CDMOs.
• Excellent interpersonal and communication skills (written and oral) with the ability to effectively and concisely present data to peers, management, and external groups.
• Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making.
• Able to travel domestically and internationally as needed, up to 20% of the time.

The anticipated salary range for candidates who will work in South San Francisco, CA is $225,000 - $250,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

About This Role

Our pharmaceutical team is looking for a highly motivated early-career Scientist to join our Biologics Formulation team. This role offers a unique opportunity to contribute to next-generation protein formulation development while working with cutting-edge high-throughput automation technologies in a fast-paced startup environment.

As a Scientist, you will execute and optimize protein formulation protocols across liquid and solid dosage forms, supporting the development of high concentration biologics and advanced systems. You will play a key role in establishing automated workflows and maintaining robust data management practices as the team scales its capabilities.

Responsibilities

Formulation Development & Execution

• Execute protein formulation experiments for liquid and solid dosage forms, including excipient screening, pH optimization, and stability assessment
• Prepare and characterize high concentration protein formulations and evaluate formulation stability under various conditions
• Support development of advanced formulation
• Perform routine analytical characterization using techniques such as DLS, DSF, CE, and spectroscopy

High-Throughput Automation & Data Management

• Develop, optimize, and validate automated liquid handling protocols for high-throughput formulation screening
• Program and maintain automated equipment workflows, troubleshoot technical issues, and implement process improvements
• Design and execute plate-based experimental layouts for parallel formulation studies
• Maintain comprehensive electronic laboratory notebook (ELN) documentation with rigorous data integrity standards
• Organize, analyze, and visualize large datasets from high-throughput experiments using appropriate software tools

Collaboration & Communication

• Work independently on assigned projects while maintaining clear communication with team members
• Present experimental results and progress updates in team meetings
• Contribute to technical reports, SOPs, and regulatory documentation
• Adapt quickly to changing priorities and deliver results within startup timelines

Basic Qualifications

• PhD in Pharmaceutical Sciences, Biomaterials, Materials Science, Chemistry, Chemical Engineering, or related discipline
• Hands-on experience with protein formulation and characterization techniques
• Strong foundation in protein chemistry and physical biochemistry principles
• Proficiency with data analysis tools (e.g., Excel, GraphPad Prism, Python, or R)
• Demonstrated ability to work independently with strong organizational skills Experience with electronic lab notebooks and structured data management
• Excellent written and verbal communication skills

Preferred Skills And Experience

• Industry experience in biopharmaceutical formulation development
• Experience with liquid handling automation platforms (e.g., Tecan, Hamilton, Beckman) 
• Familiarity with protein crystallization techniques
• Knowledge of lyophilization, spray drying, or other solid-state processing methods 
• Experience in startup or fast-paced R&D environments
• Programming experience for data analysis and visualization (Python, MATLAB, or similar)

What We Offer

• Opportunity to work at the intersection of biotechnology and space manufacturing
• Hands-on experience establishing high-throughput formulation capabilities
• Collaborative team environment with mentorship from senior scientists
• Professional development opportunities in a rapidly growing company

Pay Range

• Salary Range: $100,000.00 - $140,000.00/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for long-term incentives in the form of stock options and/or long-term cash awards

About This Role

Our pharmaceutical team is looking for a highly motivated and creative Analytical Scientist who will lead efforts in improving therapeutics with microgravity. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda’s product culture and will play a significant role in establishing the low earth orbit economy.

Responsibilities

• Develop, optimize and validate analytical methods for characterizing drug substances and drug products
• Carry out hands-on experiments in the lab and working with external testing sites to fully characterize drug substances and drug products
• Collaborate closely with product development, formulation sciences, and broader engineering groups to drive drug development activities
• Author relevant documents such as methods, protocols, validation reports, and regulatory filings as needed

Basic Qualifications

• M.S. or Ph.D. in Analytical Chemistry (or similar field such as Chemistry, Biochemistry, Chemical Engineering, Materials Science or related fields)

Preferred Skills and Experience

• Experience with UV, DLS, DSF, NMR, CD, FTIR, Raman, and particle sizing technologies
• Experience with chromatographic and affinity-based methods (HPLC/UPLC, LC-MS/MS, SEC-MALS, GC, CE-SDS, icIEF, SDS-PAGE)
• Track record of method development as demonstrated by publications in peer-reviewed journals, IND/BLA/NDA filings, and presentations at scientific conferences
• Experience as the responsible engineer or technical owner of projects across project lifecycle

Pay Range

• Salary Range: $100,000.00 - $160,000.00/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for long-term incentives in the form of stock options and/or long-term cash awards