Principal Scientist, Vaccine Drug Product Development

Principal Scientist – Vaccine Drug Product Development (VDPD)

Location:

West Point, PA

Vaccine Drug Product Development (VDPD), part of our Research Laboratories, seeks a Principal Scientist to develop novel vaccine drug products that significantly improve global human health. The department is responsible for advancing vaccine adjuvants and drug products from preclinical studies through Phase III clinical trials to commercialization, ensuring robust composition, packaging, and scalable processes without compromising safety, efficacy, or stability.

• Lead a matrixed team in designing, executing, and documenting experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production and to scale‑up these processes to pilot plant and commercial facilities.
• Work independently in a hands‑on laboratory environment while collaborating within the group, across functional areas, and with external partners.
• Provide active strategic and technical leadership on program development teams.
• Communicate data and conclusions verbally, in written documents, reports, and technical presentations.
• Facilitate leadership and manage stakeholder expectations as part of the stage‑gate process.
• Lead teams in advancing science and technology innovation, business process improvement, and clinical manufacturing capability build.
• Mentor less experienced scientists.

• Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with minimum 8 years of relevant industrial experience;
• M.S. degree in a similar field with minimum 10 years of relevant industrial experience;
• B.S. degree in a similar field with minimum 12 years of relevant industrial experience;
• Proven written and verbal communication skills;
• Ability to prioritize, plan, and execute work with limited guidance;
• Ability to work in a dynamic and fast‑paced team environment;
• Demonstrated facilitative leadership and influencing skills;
• Hands‑on laboratory skills;
• Experience developing vaccine adjuvant and/or vaccine drug product processes, or significant nucleic acid and lipid nanoparticle experience, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.);
• Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies;
• Experience with engineering principles used in process development and process scale up/scale down;
• Experience with technical transfer of processes from lab to pilot plant and/or commercial sites, including the use of risk assessment tools;
• Track record of difficult technical problem solving;
• Ability to develop and implement new methods/processes;
• Experience with GMP manufacturing of clinical supplies;
• Experience using statistical principles to understand, predict, and communicate process robustness;
• Experience with root‑cause analysis and investigations (FMEA, fishbone, etc.);
• Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or drug products);
• Experience responding to regulatory questions related to drug products;
• Experience, desire, and a track record of effective mentorship of less experienced scientists toward time‑bound goals.

• Experience with sterile product manufacturing and aseptic technique;
• Experience with colloidal systems and characterization of colloids including emulsions;
• Familiarity with ISO, CFR, ICH, and USP guidelines as they relate to sterile products;
• Familiarity with Quality by Design principles and experience applying QbD tools and principles to products in development;
• Experience with process modeling;
• Experience with liquid and lyophilized drug product formulation development;
• Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing;
• Experience with direct people management.

Salary range: $173,200 – $272,600. Eligible for annual bonus and long‑term incentive, if applicable.…