Director, Global Drug Substance Commercialization, Conjugation

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as the Director for Drug Substance (DS) Commercialization of Conjugation. Lead and facilitate the launch readiness and commercial supply of glycoconjugate drug substances. This role focuses on technical launch planning and execution, coordinating cross-functional efforts for regulatory filings and launch supplies. Provide leadership to ensure effective communication of scientific and commercial rationale to stakeholders and regulatory agencies. Work with the organization to ensure on-time execution and planning for commercial lifecycle management. Collaborate on overall program strategy, with primary responsibility for the critical raw material strategy. Report to the Executive Director for Global DS Commercialization. This remote position is based in San Carlos, CA or Raleigh, NC.

Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A., or 16+ years for 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
• 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 with the ability to interact effectively with people of diverse backgrounds and perspectives
• 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 that will stretch the organization and push the boundaries within the industry

Responsibilities

• Provide strategic and scientific leadership for polysaccharide activation and conjugation processes with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities
• Build a strong and highly-skilled team for the global network with special focus on conjugation manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals
• Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations
• Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of carrier proteins for pipeline products
• Ensure robust processes exist to support technical transfers and integration of new technologies
• Support of our internal and external manufacturing network, including materials management and data analytics
• Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to the Manufacturing organization for commercialization
• Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to the Boards of Health for regulatory submissions for commercialization
• Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively
• Contribute as DS Commercialization lead for Conjugation and as member of the Global Manufacturing Operations organization, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients

Preferred Qualifications

Experience with glycoconjugate vaccines is highly preferred

Benefits

• Competitive compensation package
• Comprehensive benefits
• Equity component
• Salary Range: $208,000 – $242,000 (SF Bay Area)
• Remote work