Associate Principal Scientist, Vaccine Drug Product Development
Core
Lead the design and development of vaccine formulations and drug product processes from Phase 1 through pivotal clinical development, focusing on multi-antigen/adjuvant combinations and manufacturing readiness.
Role type
Senior IC scientist (vaccine drug product development)
Builds
Vaccine drug products (multi-antigen/adjuvant, mRNA-LNPs, bioconjugates, VLPs) for clinical trials and manufacturing
Domain
Biopharmaceuticals / Vaccines
Required skills
Vaccine formulation development, Adjuvant system expertise, GMP manufacturing execution, Technology transfer to CMOs/CDMOs, Analytical method development, Regulatory CMC authoring, Process scale-up and robustness, Data interpretation for decision-making
Preferred skills
Experience with Bioconjugates, VLPs, mRNA-LNPs, recombinant protein vaccines, Scientific leadership (mentoring, publications, patents)
Technologies
DLS, chromatography, mass spectrometry, spectroscopy, binding assays, thermal analysis, particle characterization, lyophilization, sterile filtration, fill-finish
Responsibilities
Lead formulation development for multi-antigen/adjuvant products; Define analytical strategies for product characterization; Lead process design, scale-up, and manufacturing readiness; Oversee technology transfer to internal sites and CMOs/CDMOs; Author CMC content for regulatory submissions; Integrate data to drive CMC decisions; Mentor scientists and build technical capabilities
Seniority
Senior, hands-on IC
