Vaxcyte

Manager

• Provide strategic and scientific leadership for polysaccharide to protein conjugation 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 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 the conjugate drug substance. Provides technical representation into initial technology transfer, product launch, product lifecycle, to the end of life/product retirement and for defining/developing the next generation of production technologies.
• 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 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 with the DS 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.
• 10-30% travel required.

Senior Manager, Global Drug Substance Commercialization, Conjugation