OverviewFor 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/DELIVERABLESResponsibilities:- 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
- Coaching, training and administration of performance management to personnel (primarily, but not limited to, direct reports)
Basic 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.
Additional Skills and Preferences:- Comprehensive knowledge and understanding of vaccine formulation and process development, and parenteral manufacturing and aseptic technologies.
- Background encompasses both innovation and technical development of wide array of vaccine platforms.
- Proven record of developing processes and deep understanding of principles and analytical techniques necessary to characterize recombinant protein antigens, antigen-adjuvant compatibility and interactions (e.g., stability and adsorption isotherm characterization), and colloidal/emulsion systems (e.g., DLS, particle sizing, zeta potential, microscopy, biophysical/structural methods for adsorbed and emulsion-associated antigens).
- Hands-on experience with squalene oil-in-water emulsion adjuvants including emulsion manufacturing operations such as microfluidization and high-shear / high-pressure homogenization.
- Working knowledge of vaccine-specific regulatory expectations (FDA CBER, EMA biologics, WHO TRS) and applicable ICH guidelines (Q5C, Q5E, Q6B, Q8-Q11) for biological products, including comparability, stability, and CMC submission strategy for adjuvanted vaccines. Late-stage vaccine drug product development experience especially BLA filing experience is preferred.
- Extensive experience collaborating with key partner functions to develop innovative solutions with a patient focus in an integrated fashion.
- Familiarity with OMV (Outer membrane vesicles) delivery platforms is a plus.
- May also need to support adjacent biologics programs (monoclonal antibody, proteins and peptide programs) in various stages of development.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $281,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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