Associate Principal Scientist, Vaccine Drug Product Development

Introduction to the Role

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.

Key Responsibilities

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.

Education & Experience Requirements

Education: BS, MS, or PhD in Biochemistry, Chemistry, Chemical/Biochemical Engineering, Immunology, Pharmaceutics or related fields of study.

Experience: 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.

Required Skills & Experience

• Formulation Development: Independently design vaccine formulation studies and strategies addressing antigen–adjuvant interactions, adsorption, excipient selection, immunogenicity, and chemical, physical, and colloidal stability.
• Product Characterization: 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.
• Process Engineering and Scale-Up: 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.
• CMC and GMP Execution: Translate development processes into manufacturing-ready operations; review batch records; support GMP manufacturing, investigations, clinical supply, and work with internal sites and CMOs/CDMOs.
• Regulatory Authoring: Author and review CMC sections for INDs, BLAs, and MAAs; contribute to responses to information requests and support health authority queries with clear scientific rationales for formulation and process decisions.
• Data Interpretation and Decision-Making: Design experiments with clear criteria, assess technical risks, and convert complex data into evidence-based recommendations for formulation, process, and CMC strategy.
• Scientific Communication and Collaboration: Communicate complex findings clearly, influence multidisciplinary stakeholders, and build effective partnerships across functions and external organizations.
• Scientific Leadership: Demonstrate technical impact through mentoring, capability building, conference presentations, publications, patents, or comparable scientific contributions.

Ways of Working and Behaviors

• 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.

Working Model

This is a lab-based position with an on-site requirement. However, there is flexibility for occasional remote work based on individual needs and team priorities.

Location and Travel

Primary Site: Gaithersburg, MD (Biopharmaceuticals R&D). Travel: Up to 10% travel, primarily to CMOs/CDMOs, and internal manufacturing sites.