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Salary: USD 210,000 - 245,000 / annual
Vaxcyte is a clinical-stage vaccine innovation company developing high-fidelity vaccines to protect against bacterial diseases including invasive pneumococcal disease, Group A Strep, and Shigella.
The Director for Drug Substance (DS) Commercialization of Conjugation will lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances. 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.
Key responsibilities include:
- Provide strategic and scientific leadership for polysaccharide activation and conjugation processes with internal and external stakeholders, ensuring successful execution of launch plans and post-launch commercial activities
- Build a strong and highly-skilled global team with special focus on conjugation manufacturing processes, supporting resourcing recommendations to meet organizational goals
- Continuously improve process understanding and robustness using staff and laboratory resources to monitor, trend, and optimize operations
- Collaborate with cross-functional teams including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering to drive successful development and commercial launch
- Ensure robust processes exist to support technical transfers and integration of new technologies
- Provide leadership for process validation and process comparability activities, effectively communicating scientific and commercial rationale to manufacturing and regulatory stakeholders
- Engage in technical reviewing and authoring of regulatory filings and responding to health authority questions
- Effectively communicate process performance to key stakeholders and build strong working relationships
- Contribute as DS Commercialization lead for Conjugation as member of the Global Manufacturing Operations organization
- Travel 10-30% as required
The role reports to the Sr. Director, Global Drug Substance Commercialization, Conjugation.
REQUIREMENTS:
- Degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with minimum 10+ years relevant experience (Ph.D.), 12+ years (M.S./M.A.), or 16+ years (B.S./B.A.)
- Extensive experience in conjugate production processes, including polysaccharide activation, conjugation to carrier proteins, and associated purification processes across multiple operational scales; experience with glycoconjugate vaccines highly preferred
- Leadership experience in MSAT (Manufacturing Science and Technology) or Process Development in supervisory and/or matrixed team roles
- Ability to leverage deep technical knowledge in collaborative manner to establish strategic plans and achieve collective goals
- Excellent organization, problem-solving, and strategic planning skills
- Highly skilled in verbal and written communication with ability to interact effectively with diverse backgrounds and perspectives
- Proactive recognition of needs and potential challenges, directing activities to implement effective solutions
- Ability to seek and analyze data from variety of sources to support decisions and align others with organizational strategy
- Entrepreneurial and creative approach to developing innovative ideas that stretch the organization and push industry boundaries
