Associate Director/ Staff Scientist, Downstream Development for Protein Development & Manufacturing

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 individual to join Vaxcyte’s Vaccine Product Development organization as an Associate Director/Staff Scientist of downstream development and manufacturing within the Protein Development and Manufacturing group.

· A dynamic leader that can cultivate a team and develop employees while driving progress on the pipeline.
·  An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to achieve company goals.
·  A scientific thought leader capable of synthesizing complex biochemistry into well-designed experiments capable of illuminating the unknown; able to plan and utilize team strengths to execute.
·  The ability to analyze and concatenate data to draw conclusions, make clear decisions, and communicate salient points concisely.
·  A strong sense of ownership and accountability; commitment to Vaxcyte’s mission.
Essential Functions

• Take the lead in developing downstream purification process for multiple protein antigens that comprise the VAX-A1 vaccine, an early stage clinical candidate; purification process must be robust, scalable, and cost-effective. 
• Spend ~50% time in the lab.
• Manage a group of 2-3 direct reports. 
• Collaborate with Analytical Development to develop and implement assays to assess product quality, including novel product concentration assays.
• Participate in cross-functional project teams and provide regular progress updates.
• Lead technology transfer activities for the process developed at Vaxcyte to an external CMO for GMP production.

Requirements

• PhD in Chemical Engineering, Biochemistry, or a related discipline, with 5+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience.
• In depth protein purification knowledge and experience, including familiarity with AKTA lab-scale and preparative chromatography systems and Unicorn software.
• Both practical experience with and theoretical knowledge of engineering principles involved in scaling processes from development lab to pilot / manufacturing plant  Working knowledge of the requirements of GMP manufacturing; hands-on GMP experience a plus.
• Experience working with CMOs highly desired; ability to effectively transfer processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person-in-plant oversight activities.
• Extensive hands-on experience purifying proteins from crude lysate to high purity.
• Solid understanding of the principals of DoE (Design of Experiments); practical experience with DoE software; proficient in the design and interpretation of statistically modelled experiments.
• Experience with depth, nominal, and tangential flow filtration.
• Ability and desire to learn upstream cell-free production system used to express proteins.
• Proficiency running gel- and column-based analytical methods a plus; such methods may include SDS-PAGE, Western blotting, IEF, SEC, HIC, IEX, RP, Mass Spec, and binding affinity or activity assays (such as MSD or ELISA)  Experience writing IND section(s) a plus.
• Demonstrated success working in a cross-functional team environment on multiple projects; ability to work both on a team (as member and/or leader) and independently to deliver results.
• 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 & Manufacturing

Location: San Carlos, CA

Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.