Group Leader, 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, carrier-sparing 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-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. 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 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. 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-31, 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 individual to join our Formulation and Drug Product Development team.
 
The candidate will have extensive knowledge and practical experience in formulation development of biologics and/or vaccines, preferably adjuvant containing formulations, complemented with a broad range of vaccines analytical techniques and in particular in-depth experience in biophysical characterization of formulations. The candidate will have a strong industry-based experience in bringing a product from early to late-stage development, including process scale-up and manufacturing. Having worked with external analytical and manufacturing CMOs would be beneficial as well as a good understanding of GxP testing and manufacturing guidelines.
 
This position is for a scientific and Leadership which will be minimally lab based, with management responsibilities for 2-3 junior scientists across multiple projects. This role will require excellent scientific judgement, independence, rigor and thorough record keeping, as well as sound Leadership principles and the ability to work within and across projects and Teams seamlessly.
 
Reporting to the Director of Formulation Development, the primary responsibility for the incumbent will be to lead the formulation Team in facilitating formulation development activities across all our programs, leading scientific interactions with the project, analytical, DS and DP team members to move all programs though the development phase into phase 1, 2, 3 clinical trials and into preparations for commercial launch.
Essential Functions:

• Leading formulation development activities, including stability studies for thermal, freeze/thaw, and agitation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials. Use of DoE for this purpose would be preferred.
• Identification of project scientific needs/gaps, conceptual design, planning, execution through the team, data analysis and next-step proposal to both the DP and wider Project Team.
• In concert with DP management, interacted heavily with the program team and other external Vaxcyte Team members to ensure supply/demand, in vivo, DS quality, analytical methods, CMO status and timelines are all in sync with formulation development activities to hit milestones as needed.
• Interact heavily with CMOs for Tech Transfer, trouble shooting, documentation review and person-in-plant responsibilities.
• Lead Toxicology and clinical management of DP materials, particularly around a bed-side mix approach in phase 1.
• Work with external analytical and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods.
• Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
• This role requires people management and the expectation will be to develop junior scientists scientifically, personally and professionally to advance both the program(s) and careers. 

Requirements:

• BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with >10 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >6 years of relevant experience.
• The candidate should have had extensive experience in developing proteins, polysaccharides and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants (other non-vaccine biological experience also considered).
• 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
• Ability to move and multitask seamlessly between complex programs and project teams is required.
• Experience in management of junior scientists is strongly preferred, with a desire to continue in a managerial/leadership setting.
• 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 multiple projects and timelines.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team and well as across other teams.
• Detail oriented, rigorous and excellent skills in record keeping/documentation.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Sr. Director, Formulation
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $144,000 - $162,000