Director, Vaccine Formulation Development

About the role

The Lilly Bioproduct Research and Development (BR&D) organization is seeking a highly motivated scientific lead with deep, hands-on experience developing through clinical development and commercialization, and a strong emphasis on and complex antigen–adjuvant systems (e.g., aluminum- and emulsion-adjuvanted formulations).

Responsibilities

• Represent Drug Product team in CM&C teams and support the formulation and process development of recombinant protein antigens, emulsion- or aluminum-based co-formulated vaccines.
• Support the drug product development and bring in new formulation technologies to develop adjuvanted protein/subunit vaccines, bacterial vaccine platforms, and antigen-display nanoparticle.
• Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for vaccine drug product unit operations including emulsion adjuvant manufacturing, aluminum salt adsorption, sterile filtration and lyophilization (as applicable), and aseptic fill/finish of modern container/closure and presentation systems (single-vial, two-vial reconstitution, prefilled syringe, dual-chamber).
• Support tech transfer of process and formulation to clinical manufacturing sites.
• Work closely with synthetic chemistry, toxicology, ADME groups, analytical teams and device teams to develop vaccine drug products that are immunogenic, stable and patient-centric.
• Lead others in the design, execution and interpretation of experiments to drive the definition and optimization of formulations and processes.
• Innovate or assess cutting edge formulation methodologies for complex or unstable vaccine antigens and antigen-adjuvant systems.
• Identify and spearhead research efforts on understanding new vaccine technologies and establish proof of concept for technologies for appropriate assets under development.
• Establish and leverage strategic relationships with academia and start-ups to accelerate and access emerging innovation.
• Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence.
• Wear multiple functional hats so that input into various complementary parts of the project can be managed in a rapid and localized manner.
• Coach, train and administer performance management to personnel (primarily, but not limited to, direct reports).

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 including 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.