Director, Global Drug Substance Commercialization, Polysaccharide

About this role

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

The Director for Drug Substance Commercialization of Polysaccharides will lead assigned commercialization workstreams and facilitate overall launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines.

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.

This position will be reporting into the Senior Director for Global Polysaccharide Commercialization. The Director will collaborate on overall program strategy, with primary responsibility and accountability for the Polysaccharide component strategy.

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. As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, and Conjugation across all Drug Substances (DS). The range of activities will include technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle, etc.

Essential Functions:

• DS Commercialization – Provide strategic and scientific leadership for polysaccharides with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities by translating strategy into execution plans and ensuring completion of key technical milestones.

• Organization and capability building – Develop technical capabilities within the polysaccharide commercialization organization and support resource and staffing recommendations needed to achieve program and organizational objectives. Contribute to building a highly skilled team capable of supporting the global manufacturing network.

• Process robustness – Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.

• Interface – Coordinate cross-functional deliverables across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of polysaccharides for pipeline products. Identify, communicate, and escalate technical and supply risks that may impact program execution or commercial supply.

• Tech-transfer and new technologies – Ensure robust processes exist to support technical transfers and integration of new technologies, providing technical oversight to support successful execution across internal and external manufacturing sites.

• Support technical services – Support our internal and external manufacturing network, including materials management and data analytics, and provide technical oversight of CMOs to support reliable manufacturing and commercial supply.

• Process validation and comparability – 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.

• Regulatory – Engage in technical review and authoring of regulatory filings and respond to questions received from health authorities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to Boards of Health for regulatory submissions supporting commercialization.

• Communicate – Effectively and efficiently communicate process performance to key stakeholders, both internal and external. Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.

• Leadership –…