Director, Vaccine Formulation Development

Key Objectives/Deliverables

• 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)

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.

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.
• 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.