Director / Senior Director, Protein Process Development

Location
Foster City, CA, United States
Posted
Mar 01, 2021
Ref
864185363
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; 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 by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds.

Summary:

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance, and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Director / Senior Director to lead the Protein Development team.

Essential Functions:

• Manage group of four (two PhD-level scientists, and two associates); grow group to ~10 FTEs over the next 3-5 years
• Flesh out nascent Phase 3 / commercial plan for proprietary eCRM carrier protein
• In coordination with CMO, devise and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance
• Solidify complex cell-free reagent supply chain (comprised of proprietary cell extracts and lysates, a complex small molecule, and plasmid DNA)
• Lead the development of the upstream (cell-free) and downstream processes for pipeline vaccine-based proteins (transferred from Research team)
• Provide engineering expertise and leadership, ensuring developed processes are scalable, economic, and appropriately transferred to CMO
• Ensure all CMO oversight responsibilities for proteins are carried out in a manner compliant with internal Vaxcyte SOPs
• Be a key member of the CMC senior leadership team, which is charged with establishing CMC strategic direction and decisions
• Establish timelines and manage budget for Protein Development functional area
• Be an outstanding teammate

Requirements:

• PhD in Chemical Engineering or Chemistry/Biochemistry with 10+ years of relevant Pharma/Biotech industry experience, or MS in Chemical Engineering or Chemistry/ Biochemistry with 15+ years of relevant Pharma/Biotech industry experience
• Proven leadership skills
• Outstanding organization and planning skills
• Clear and compelling (written and oral) communication skills
• Phenomenal team skills; demonstrated ability to work exceedingly well in a multi- disciplinary team structure
• Ability to work in small company environment; (Vaxcyte has ~50 full-time employees)
• Experience bringing a protein (or protein-based) product to market
• Experience partnering with CMOs; Vaxcyte has contracted Lonza (Visp, Switzerland) to manufacture our proprietary eCRM carrier protein
• Broad experience authoring IND and BLA Module 3 sections
• GMP knowledge and experience, preferably as it applies to both manufacturing and QC
• Exceptionally strong from a technical / scientific perspective
- In-depth knowledge of downstream unit operations (chromatography, TFF, etc.)
- Experience with cell-free upstream technology a plus but not required
- Expert in Design of Experiments (DoE)
- Strong analytical method skills

Reports to: SVP, Process and Analytical Development

Location: Foster City, CA

Compensation:

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