[Hiring] Director, Global Drug Substance Commercialization @Vaxcyte

Role Description

The Director for Drug Substance (DS) Commercialization of Conjugation will lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including the polysaccharide activation, conjugation, and associated raw materials. 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.

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.

• Provide strategic and scientific leadership for polysaccharide activation and conjugation processes with internal and external stakeholders.
• Build a strong and highly-skilled team for the global network with special focus on conjugation manufacturing processes.
• Continuously improve process understanding and process robustness using staff and laboratory resources across the organization.
• Collaborate with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering.
• Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support our internal and external manufacturing network, including materials management and data analytics.
• Provide leadership for the execution of process validation and process comparability activities.
• Engage in technical reviewing and authoring of regulatory filings and responding to questions received from health authorities.
• Effectively and efficiently communicate process performance to key stakeholders.
• Contribute as DS Commercialization lead for Conjugation and as a member of the Global Manufacturing Operations organization.
• 10-30% travel required.

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., 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.
• Experience with glycoconjugate vaccines is 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.
• 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.
• An entrepreneurial and creative approach to developing new, innovative ideas.

Requirements

• Reports to: Sr. Director, Global Drug Substance Commercialization, Conjugation.
• Work Arrangement: Remote (may be adjusted based on business needs, job responsibilities, or changes to company policy).
• Location: Remote; prefer Raleigh, NC.

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component.
• Salary Range: $210,000 - $245,000 Remote Salary Range.

Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Recruitment Fraud Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.