Associate Principal Scientist, Vaccine Drug Product Development
About The Position
Join our Vaccines Drug Product Development team to shape the next generation of preventative therapies. We are seeking a highly motivated Associate Principal Scientist with deep experience in vaccine formulation development, adjuvant systems, and complex, co-formulated drug products. You will independently lead the design and development of formulations and drug product processes spanning Phase 1 through pivotal clinical development, with a focus on multi-antigen/adjuvant combinations and other vaccine modalities. You will drive development strategies, influence CMC decisions, provide technical leadership across multidisciplinary teams, manage external partners, and connect near-term deliverables to long-term program and patient impact. You will provide independent scientific and technical leadership for vaccine drug product programs from early formulation development through pivotal clinical development and manufacturing readiness. You will define development strategies, integrate formulation, process, analytical, regulatory, and manufacturing considerations, and translate complex data into clear program decisions. Additionally, you will: · Vaccine Formulation and Product Development: Lead formulation development for multi-antigen/adjuvant products and other vaccine modalities. Define studies, selection criteria, and control strategies addressing antigen–adjuvant interactions, compatibility, immunogenicity, and product stability across clinical phases. · Analytical Strategy and Product Characterization: Partner with Analytical Sciences to define fit-for-purpose methods and data expectations for vaccine and adjuvant characterization. Ensure analytical evidence supports formulation selection, process understanding, comparability, and control strategies. · Drug Product Process Design, Scale-Up, and Manufacturing Readiness: Lead development, scale-up, characterization, and robustness studies for vaccine drug product processes. Build process–product understanding, assess risks, and translate processes into reproducible, GMP-ready operations. · GMP Manufacturing and Technology Transfer: Lead technology transfer to internal sites and CMOs/CDMOs, review manufacturing documentation, and support engineering, clinical, and GMP batches. Oversee execution and resolve technical issues, deviations, and process risks. · CMC Strategy and Cross-Functional Leadership: Serve as the Drug Product CMC representative, shaping program strategy, development plans, milestones, and risk management. Align cross-functional teams and drive timely, evidence-based decisions. · Regulatory Strategy and Technical Documentation: Author and review technical documents and CMC content for regulatory submissions. Develop scientific rationales, respond to information requests, and support health authority interactions. · Data Interpretation and Decision Leadership: Integrate experimental and manufacturing data into clear recommendations for formulation, process, clinical supply, and CMC decisions. Build evidence packages for internal governance and regulatory review. · External Partnership, Scientific Leadership, and Capability Building: Direct external partners, align scope and timelines, and resolve scientific and operational issues. Communicate findings, mentor scientists, and strengthen technical capabilities and project delivery.
Requirements
- BS, MS, or PhD in Biochemistry, Chemistry, Chemical/Biochemical Engineering, Immunology, Pharmaceutics or related fields of study.
- BS: 10+ years; MS: 7+ years; PhD: 5+ years of experience in biopharmaceutical or vaccine development.
- Hands-on experience with one or more modalities: Bioconjugates, VLPs, mRNA-LNPs, recombinant protein vaccines.
- Demonstrated expertise in vaccine adjuvant systems (aluminum salts, lipid-based systems, other novel adjuvants) and co-formulated multi-antigen/adjuvant products.
- Proven track record in GMP manufacturing, tech transfer to CMOs/CDMOs, and clinical supply support.
- Independently design vaccine formulation studies and strategies addressing antigen–adjuvant interactions, adsorption, excipient selection, immunogenicity, and chemical, physical, and colloidal stability.
- Apply fit-for-purpose biophysical, biochemical, and compendial methods, including DLS, chromatography, mass spectrometry, spectroscopy, binding assays, thermal analysis, particle characterization, adsorption profiling, residuals, osmolality, sterility/endotoxin, and appearance assessments.
- Develop and scale vaccine unit operations, including mixing, homogenization/emulsification, suspension handling, sterile filtration, fill-finish, and lyophilization, and support process robustness and technology transfer.
- Translate development processes into manufacturing-ready operations; review batch records; support GMP manufacturing, investigations, clinical supply, and work with internal sites and CMOs/CDMOs.
- Author and review CMC content for regulatory submissions and provide clear scientific rationales for formulation and process decisions.
- Design experiments with clear criteria, assess technical risks, and convert complex data into evidence-based recommendations for formulation, process, and CMC strategy.
- Communicate complex findings clearly, influence multidisciplinary stakeholders, and build effective partnerships across functions and external organizations.
- Demonstrate technical impact through mentoring, capability building, conference presentations, publications, patents, or comparable scientific contributions.
- Proactive and Motivated: Anticipates risks and opportunities; drives timely, high-quality execution with minimal supervision.
- Collaborative and Engaged: Builds strong relationships across disciplines; communicates clearly; fosters transparency and shared accountability.
- Patient Impact Focus: Passionate about translating technical work into better patient outcomes; prioritizes quality, and safety.
- Scientific Rigor and Integrity: Upholds data integrity, methodical experimentation, and clear documentation; embraces feedback to improve outcomes.
Responsibilities
- Provide independent scientific and technical leadership for vaccine drug product programs from early formulation development through pivotal clinical development and manufacturing readiness.
- Define development strategies, integrate formulation, process, analytical, regulatory, and manufacturing considerations, and translate complex data into clear program decisions.
- Lead formulation development for multi-antigen/adjuvant products and other vaccine modalities.
- Define studies, selection criteria, and control strategies addressing antigen–adjuvant interactions, compatibility, immunogenicity, and product stability across clinical phases.
- Partner with Analytical Sciences to define fit-for-purpose methods and data expectations for vaccine and adjuvant characterization.
- Ensure analytical evidence supports formulation selection, process understanding, comparability, and control strategies.
- Lead development, scale-up, characterization, and robustness studies for vaccine drug product processes.
- Build process–product understanding, assess risks, and translate processes into reproducible, GMP-ready operations.
- Lead technology transfer to internal sites and CMOs/CDMOs, review manufacturing documentation, and support engineering, clinical, and GMP batches.
- Oversee execution and resolve technical issues, deviations, and process risks.
- Serve as the Drug Product CMC representative, shaping program strategy, development plans, milestones, and risk management.
- Align cross-functional teams and drive timely, evidence-based decisions.
- Author and review technical documents and CMC content for regulatory submissions.
- Develop scientific rationales, respond to information requests, and support health authority interactions.
- Integrate experimental and manufacturing data into clear recommendations for formulation, process, clinical supply, and CMC decisions.
- Build evidence packages for internal governance and regulatory review.
- Direct external partners, align scope and timelines, and resolve scientific and operational issues.
- Communicate findings, mentor scientists, and strengthen technical capabilities and project delivery.
Benefits
- short-term incentive bonuses
- equity-based awards for salaried roles
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
