Associate Principal Scientist, Vaccine Drug Product Development
$138.39k - $207.59kAstraZeneca
AstraZeneca seeks an Associate Principal Scientist to lead vaccine formulation and drug product development from early stages through clinical and manufacturing readiness. The role requires independent technical leadership of multi-antigen/adjuvant combinations, process scale-up, GMP manufacturing support, and cross-functional strategy in a complex therapeutic area.
Responsibilities
- Lead formulation development for vaccine products addressing antigen-adjuvant interactions, stability, and immunogenicity across clinical phases
- Partner with analytical sciences to define characterization methods and ensure evidence supports formulation and process decisions
- Direct vaccine drug product process design, scale-up, and manufacturing readiness including technology transfer to CMOs/CDMOs
- Serve as Drug Product CMC representative, shaping program strategy, development plans, and risk management
- Author and review technical documentation for regulatory submissions and support health authority interactions
Requirements
- BS, MS, or PhD in Biochemistry, Chemistry, Chemical/Biochemical Engineering, Immunology, or Pharmaceutics
- 10+ years (BS), 7+ years (MS), or 5+ years (PhD) in biopharmaceutical or vaccine development
- Hands-on experience with vaccine modalities: bioconjugates, VLPs, mRNA-LNPs, or recombinant protein vaccines
- Demonstrated expertise in vaccine adjuvant systems and multi-antigen/adjuvant co-formulated products
- Proven track record in GMP manufacturing, CMO/CDMO technology transfer, and clinical supply support
- Strong capability in regulatory authoring, CMC strategy, and data interpretation for decision-making
$138.39k - $207.59k
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