[Hiring] Director, Global Drug Substance Commercialization, Polysaccharide @Vaxcyte

Role Description

The Director for Drug Substance Commercialization of Polysaccharides will lead assigned commercialization workstreams and facilitate overall launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines. This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.

This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.

This position will be reporting into the Senior Director for Global Polysaccharide Commercialization. The Director will collaborate on overall program strategy, with primary responsibility and accountability for the Polysaccharide component strategy.

Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise.

As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, and Conjugation across all Drug Substances (DS). The range of activities will include:

• Technology transfer support
• Process characterization experiments in support of validation
• Process improvement
• Evaluation of novel process technologies
• Investigation of process related manufacturing issues
• Ensuring continuous improvement in process robustness throughout the product life cycle

Qualifications

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline
• Minimum of 10+ years of relevant experience for Ph.D.
• 12+ years for M.S./M.A.
• 16+ years for B.S./B.A.
• Extensive experience in biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales
• Experience with polysaccharides and glycoconjugate vaccines highly preferred
• Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles
• Able to leverage deep technical knowledge in a collaborative manner to establish strategic plans and achieve collective goals
• Excellent organization, problem solving and strategic planning skills
• Highly skilled in both verbal and written communication
• Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy
• An entrepreneurial and creative approach to developing new, innovative ideas

Requirements

• Travel: 10-30% travel required

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component
• Salary Range: $223,000 - $261,000 (SF Bay Area). Salary ranges for non-California locations may vary
• This role is not eligible for relocation assistance

Company Description

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases.

• Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella
• Guided by four enduring core values:
• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach.
• MODEL EXCELLENCE: Our shared commitment to demonstrating integrity, accountability, equality and clarity.