Vaxcyte is hiring a
Associate Director

Summary

Join our Mission to Protect Humankind!. The Associate Director for Drug Product (DP) Commercialization has the accountability for launch readiness and commercial supply of the Drug Product. 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.

Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A
• Broad experience in DP processes and process scale-up, including formulation, fill finish and container closure
• Leadership experience in MSAT or Process Development in supervisory/or matrixed team roles
• Able to leverage deep technical knowledge in a collaborative manner to 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 independently identifies and implements effective steps and 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 fill finish and analytical methods 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 protein manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals
• Continuously improve process understanding and process robustness by putting systems in place 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 support 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 communicate the scientific and commercial rationale for DS 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
• Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations
• Contribute as DP Commercialization lead and as member of the Global Manufacturing Operations, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients. Delegate effectively, celebrate diversity within the team, and manage team performance with a strong focus on colleague development