Associate Principal Scientist, Vaccine Drug Product Development

AstraZeneca • Gaithersburg, MD

4d • Onsite

About The Position

AstraZeneca is seeking an Associate Principal Scientist to provide independent scientific and technical leadership for vaccine drug product development, from early formulation work through pivotal clinical development and manufacturing readiness. The role focuses on multi-antigen/adjuvant combinations and other vaccine modalities, including formulation design, product characterization, process development, scale-up, and GMP readiness. The scientist will develop program strategies, integrate formulation, analytical, process, regulatory, and manufacturing considerations, and translate complex data into evidence-based decisions.

The role includes leading technology transfer to internal sites and external CMOs/CDMOs, supporting engineering, clinical, and GMP batches, and resolving technical issues and process risks. As the Drug Product CMC representative, the scientist will shape development plans, milestones, and risk management; author and review technical and regulatory documents; support health authority interactions; and mentor scientists and build technical capabilities.

This is a lab-based, on-site position in Gaithersburg, Maryland, with flexibility for occasional remote work based on individual needs and team priorities. Travel is up to 10%, primarily to CMOs/CDMOs and internal manufacturing sites. The position is within AstraZeneca’s Biopharmaceuticals R&D organization and is focused on advancing vaccine science and patient impact.

Requirements

• BS, MS, or PhD in Biochemistry, Chemistry, Chemical or Biochemical Engineering, Immunology, Pharmaceutics, or a related field.
• Experience in biopharmaceutical or vaccine development: 10+ years with a BS, 7+ years with an MS, or 5+ years with a PhD.
• Hands-on experience with one or more of the following modalities: bioconjugates, VLPs, mRNA-LNPs, or recombinant protein vaccines.
• Demonstrated expertise in vaccine adjuvant systems, including aluminum salts, lipid-based systems, or other novel adjuvants, and in co-formulated multi-antigen/adjuvant products.
• Proven track record in GMP manufacturing, technology transfer to CMOs/CDMOs, and clinical supply support.
• Ability to independently design vaccine formulation studies addressing antigen–adjuvant interactions, adsorption, excipient selection, immunogenicity, and chemical, physical, and colloidal stability.
• Ability to 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.
• Experience developing and scaling vaccine unit operations, including mixing, homogenization/emulsification, suspension handling, sterile filtration, fill-finish, and lyophilization, and supporting process robustness and technology transfer.
• Ability to translate development processes into manufacturing-ready operations; review batch records; support GMP manufacturing, investigations, and clinical supply; and work with internal sites and CMOs/CDMOs.
• Experience authoring and reviewing CMC sections for INDs, BLAs, and MAAs, contributing to responses to information requests, and supporting health authority queries.
• Ability to design experiments with clear criteria, assess technical risks, and turn complex data into evidence-based recommendations for formulation, process, and CMC strategy.
• Strong scientific communication, collaboration, stakeholder-influence, and external-partnership skills.
• Scientific leadership demonstrated through mentoring, capability building, conference presentations, publications, patents, or comparable contributions.
• Proactive, collaborative, patient-focused, and committed to scientific rigor, data integrity, quality, safety, and clear documentation.
• Ability to work on site in a lab-based role, with occasional remote work flexibility, and travel up to 10%.

Responsibilities

• Lead vaccine formulation development for multi-antigen/adjuvant products and other vaccine modalities; define studies, selection criteria, and control strategies.
• Partner with Analytical Sciences to define fit-for-purpose methods and characterization data expectations for vaccines and adjuvants.
• Lead development, scale-up, characterization, and robustness studies for vaccine drug product processes and prepare reproducible, GMP-ready operations.
• Lead technology transfer to internal sites and CMOs/CDMOs; review manufacturing documentation; support engineering, clinical, and GMP batches; and resolve technical issues, deviations, and process risks.
• Serve as the Drug Product CMC representative, shaping program strategy, development plans, milestones, and risk management, and aligning cross-functional teams.
• 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 recommendations and evidence packages for formulation, process, clinical supply, CMC, governance, and regulatory decisions.
• Direct external partners, align scope and timelines, and resolve scientific and operational issues.
• Communicate scientific findings, mentor scientists, and strengthen technical capabilities and project delivery.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed