Senior Manager, Global Drug Substance Commercialization, Critical Raw Materials

Vaxcyte•San Carlos, CA

63d•Onsite

About The Position

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 Senior Manager for Drug Substance (DS) Commercialization has the accountability for launch readiness and commercial supply of critical raw materials for production of eCRM and associated components for 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, launch supplies commercial supply of critical raw materials for production of eCRM and associated components for glycoconjugate vaccines and post-launch process robustness initiatives. This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material 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 DS Commercialization, Protein. The Senior Manager will collaborate on overall program strategy, with primary responsibility for supporting development and execution of biologic critical raw material process strategy, troubleshooting and robustness study design and execution for critical raw materials. Global Manufacturing Science and Technology (GMSAT) 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 Technical Operations organization, GMSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS). The range of activities will include DS technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, and investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle etc.

Requirements

Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 5+ years of relevant experience for Ph.D., 8+ years for M.S./M.A., or 12+ years for B.S./B.A.
Broad experience in protein processes, including bacterial fermentation, recovery, and purification across multiple operational scales. Experience with cell free protein synthesis and associated critical raw materials desired.
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 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

DS Commercialization - Provide strategic and scientific leadership for critical raw materials with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
Process robustness - Continuously improve process understanding and process robustness by putting systems in place to monitor, trend, and optimize operations.
Interface - Collaboration with cross-functional teams across the network, including Regulatory, Process Development, Quality, Supply Chain, Procurement, and DS Operations, to drive the successful development and commercial launch of carrier proteins for pipeline products. 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.
Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies.
Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics.
Process validation and comparability - Provide support for the execution of process validation and process comparability activities.
Regulatory - 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.
Communicate - 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.
Executing for Results - 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.
Leadership - Contribute as member of the DS Commercial MSAT team, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.
Travel - 10-30% travel required.