Director, Formulation Development

Company Profile:
 
Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-XP, a PCV with coverage of 31 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
 
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 150 employees and anticipates continued, significant growth. Following the October 2022 follow-on equity offering, which generated approximately $651 million in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. On October 24, 2022, the Company announced positive topline safety, tolerability and immunogenicity data from the Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-XP, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
 
Summary:
 
Vaxcyte is looking for an energetic and talented leader to join our Formulation and Drug Product Development team. Development of a 24-valent (ie 24 Drug Substances) in a single Drug Product, including a particulate adjuvant, is a formidable challenge, to the point where this is one of the most complicated Drug Products ever to have been produced. The applicant needs to relish this type of complexity and depth of challenge. This is an opportunity to play a major role in the development of a vaccine to significantly improve the global health for both infants and adults.
 
The candidate will have extensive knowledge and practical experience in formulation development of Biologics and/or vaccines, preferably adjuvant containing formulations, complemented with an understanding of a broad range of analytical techniques for in-depth biophysical characterization of these formulations. The candidate will have a strong industry based experience in bringing a product from early to late-stage development, including process scale-up, with non-GMP and GMP manufacturing utilizing a broad network of CDMOs.
 
This is a Leadership position, managing a team of 4-5 scientist of varying levels with the primary responsibility for the incumbent to facilitate formulation development activities of Vaxcyte’s lead and early development product candidates from pre-clinical through Ph1/2/3, culminating in BLA filing and commercial manufacturing.
Essential Functions:

• Effectively lead the Formulation Team to deliver developmental and late-stage formulation support across intermediates, DS and DP, through QbD approaches (DoE etc) where appropriate.
•    Understand, nominate and update formulations to support intermediates, DS and DP.
•    Design and execute suitable studies through the formulation team to achieve the above, in concert with external teams to gain adequate alignment with QC, QA, Regulatory and manufacturing teams.
•    Develop the Formulation Team personally, scientifically and with humility to continue to successfully work in a matrix format across multiple projects.
• Represent the Formulation team at the Project Teams to propose approaches, manage timelines, gain alignment within the wider team and generate concise and efficient planning of the required work.
• Lead interactions with external CDMO partners for stability study support, process development and non-GMP and GMP manufacturing as needed.
• Work with external manufacturing CMOs to enable tech transfer and implementation of processes.
• Work with the DP Process Development Team to generate suitable early and late-stage manufacturing procedures as necessary.
• Work with the DP Analytical Team to support appropriate formulation studies to generate concise and directive data sets.
• Evaluate container closure requirements as needed and manage pre-filled syringe regulatory expectations accordingly.
• Draft development reports and IND/Regulatory sections where needed.
• Lead in vivo study material generation and co-ordinate with the in vivo Team Leads.

Requirements:

• BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with >9 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >7 years of relevant experience.
• Extensive experience in developing mAb/proteins, and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants.
• Experience leading stability studies is required and the use of DoE for complex system optimization would be required.
• Experience of manufacturing within GxP environments either directly or through CMOs.
• Experience in managing personnel is required.
• Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
• The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate Vaxcyte’s multiple projects and timelines.
• Strong interpersonal skills using the ability to communicate effectively with humility within and between teams.
• Detail oriented, rigorous and excellent skills in record keeping/documentation.
• All Vaxcyte employees require vaccination against COVID-19. 

Reports to: Senior Director of Formulation & Drug Product Development
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $207,000 - $225,000