Director, Vaccine Formulation Development

Location: Indianapolis

Director, Vaccine Formulation Development Skip to main content

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Career Opportunities Director, Vaccine Formulation Development page is loaded## Director, Vaccine Formulation Development Apply locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Todayjob requisition :
R-106581

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.
** Overview
* * For more than 150 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company.

The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies.

The drug product team is also investing in building new platforms to support complex formulations such as vaccines, lipid nanoparticles, antibody drug conjugates and AAV and other non-viral vector delivery.

We are 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).

Experience with nanoparticle antigen display / VLP-like platforms is highly desirable. Familiarity with mRNA‐LNP vaccine drug product development is a plus but not required.
** KEY OBJECTIVES/DELIVERABLES*
* ** 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…