Director, Protein Development and Clinical Manufacturing
San Carlos, CA, USA
Posted on Wednesday, September 27, 2023
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.
The Protein Development and Clinical Manufacturing team is looking for an experienced manufacturing sciences and technology (MSAT) engineer to help bring our lead program, Vax-24, to market. The Protein team consists of both upstream and downstream process unit operations, as well as the manufacturing processes for making the critical raw materials for producing proteins by cell free protein synthesis. A successful candidate will bring experience, leadership, creativity, and excellent communication skills to the team. In this role, the successful candidate will have the opportunity to impact the scale up and industrialization of cell free protein synthesis for the manufacture of best-in-class vaccines for world markets.
- Develop and execute upon a high-level plan for validating the manufacturing process for the protein component of Vax-24.
- Work with Process Development SMEs within the group and at CMO to define complete risk assessments for critical process parameter identification.
- Collaborate with CMO to develop a validation plan for at-scale validation of the protein manufacturing process and drive the execution of that plan.
- Define risks associated with tech transfer and scale up to facilitate design of laboratory experiments focused on determining successful at-scale parameter ranges.
- Work with internal stakeholders (e.g., Regulatory) to ensure that the Protein validation strategy fits within the program-wide strategy.
- Collaborate with project management to maintain a detailed timeline for the activities that must be completed prior to a PPQ campaign – communicate to team when activities are at risk of causing delays to timeline.
- Manage manufacturing expansion to enable commercial production of the Vax-24 protein.
- Understand process requirements for the entire process.
- Communicate process requirements to facilities engineers both internal and at CMOs to ensure fit for purpose design.
- Creatively apply experience to ensure process design specifications are met on time and with high quality standards.
- Manage CMO oversight activities.
- Perform CMO oversight such as reviewing of pre-campaign documentation and batch records, reviewing and closing of deviations, reviewing and approving batch release documentation for protein components as well as critical raw materials.
- Develop and maintain a strong working relationship with the CMO to ensure alignment on both technical and business objectives.
- Suggest, solicit buy-in, and then implement improvements to Vaxcyte’s CMO oversight (e.g., improved data tracking, more efficient documentation review, etc.).
- Present/communicate strategies and status updates to the Protein team as well as the broader CMC team.
- PhD in Chemical/Biochemical Engineering or similar, with 7+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience.
- In depth experience with technology transfer and process validation of fermentation processes and/or downstream processes. Experience with cell free protein synthesis is a plus.
- Strong understanding of the engineering principles of scale up. Able to anticipate technical challenges and possible root causes of scale increase before they happen.
- Understanding of scale down model design and execution to support process validation.
- Ability to dissect a manufacturing issue, conduct root cause assessments, and design experiments to test hypotheses stemming from manufacturing observations.
- Strong ability to motivate, mentor, and connect with junior team members.
- Strong sense of organization, preferably with experience managing timelines using a tool such as Microsoft Project.
- Ability to work across several teams to pull required information from SMEs and integrate it into centralized plan.
- Proven track record of successful collaboration between organizations, preferably with contract manufacturers
- Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
- Strong interpersonal skills, with excellent written and verbal communication skills.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Senior Director, Protein Process Development and Manufacturing
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $211,000 - $228,000
Send resumes to:
825 Industrial Road, Suite 300
San Carlos, CA 94070
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.