Director, Vaccine Formulation Development
$177,000–$281,600 year
On-site · Indianapolis, Indiana, United States
Job Summary
Lead the Vaccine Formulation Development efforts for Lilly’s vaccine drug product programs, driving the development and commercialization of complex, adjuvanted vaccines from lab-scale to clinical/mass manufacturing. Represent the Drug Product team in CM&C activities, develop and implement new formulation technologies for protein/subunit vaccines, bacterial platforms, and antigen-display nanoparticle systems, and oversee process capabilities from lab scale through early clinical scale to scalable manufacturing operations (emulsion adjuvant manufacturing, aluminum salt adsorption, sterile fill/finish, lyophilization). Manage tech transfer to clinical sites, collaborate with chemistry, toxicology, ADME, analytical, and device teams to ensure immunogenic, stable, and patient-centric products, and lead design, execution, and interpretation of experiments to optimize formulations and processes. Drive innovation in vaccine technologies, establish proof of concept for new assets, build strategic academic and start-up collaborations, and promote an active innovation agenda through publications, presentations, and industry influence. Provide coaching, training, and performance management to personnel (primarily direct reports) and wear multiple functional hats to integrate project inputs across disciplines. Requires a PhD and a minimum of 10 years in vaccine drug product formulation development, with leadership experience across development, tech transfer, regulatory readiness, and manufacturing readiness; strong knowledge of regulatory expectations and a track record of collaboration and practical, hands-on formulation development.”,
Required Qualifications
- PhD in chemistry, biochemistry, chemical engineering, or related discipline
- 10 years of experience in the pharmaceutical or biotech industry developing vaccine drug product formulations and processes
- Hands-on experience with adjuvanted protein/subunit vaccines, bacterial vaccine platforms, and antigen-display nanoparticles
- Experience with preparation of control strategies and regulatory submissions supporting clinical development and licensure
- Demonstrated leadership of vaccine drug product programs across drug substance handoff, formulation development, process development, technology transfer, and clinical/commercial manufacturing readiness
- Experience supervising scientists and engineers
- Comprehensive knowledge of vaccine formulation and process development, parenteral manufacturing and aseptic technologies
- Background encompassing innovation and technical development of various vaccine platforms
- Experience with analytical techniques for characterizing antigens and adjuvant interactions (stability, adsorption isotherms, colloidal/emulsion systems)
- Hands-on experience with squalene oil-in-water emulsion adjuvants and related manufacturing operations
- Knowledge of regulatory expectations (FDA CBER, EMA biologics, WHO TRS) and ICH guidelines (Q5C-Q11) for biological products
- Late-stage vaccine drug product development experience, especially BLA filing, preferred
- Experience collaborating with partner functions to develop patient-focused solutions
- Familiarity with OMV delivery platforms is a plus
- Opportunity to support adjacent biologics programs (mAbs, proteins, peptides) during development
- Commitment to equal opportunity employment and accommodation processes
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