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Director, Global Analytical Sciences and Technology (ASAT) Drug Substance
VaxcyteSan Carlos, United Statesfull_timeVerifiedPosted 19 Nov 2024
💰 $236,000/yr($220,000/yr – $236,000/yr)
About the 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, periodontitis 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 Global ASAT Drug Substance (DS) will lead and facilitate the analytical (development, tech transfer and lifecycle of commercial manufacturing) program prioritization, and execution to drive the successful launch of products. This role provides leadership in the development and implementation of analytical methods to characterize and ensure the quality of drug substances throughout the lifecycle of commercial manufacturing, with a focus on understanding and controlling critical quality attributes (CQAs) of the drug substance, adhering to all relevant regulatory standards and guidelines. In this role the incumbent will serve as the analytical lead and SME supporting the analytical launch readiness and testing support for commercial supply of glycoconjugate drug substances, including the testing of activated polysaccharide, conjugated material, and associated drug substances. Works in alignment with network organization to ensure on-time execution and appropriate planning for commercial lifecycle management 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 analytical and scientific rationale for Raw materials, DSI and DS testing 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 the analytical readiness and lifecycle management for commercial manufacturing. Reporting into the Senior Director for Global ASAT. The Director will collaborate on overall program strategy, with primary responsibility and accountability for the analytical leadership for commercial drug substance (DSI and DS) functions across the network. The Global MSAT (including ASAT) group is responsible for successfully and seamlessly transitioning the vaccine processes and analytical methods 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 aspects of analytical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS) and Drug Products (DP).
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, periodontitis 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 Global ASAT Drug Substance (DS) will lead and facilitate the analytical (development, tech transfer and lifecycle of commercial manufacturing) program prioritization, and execution to drive the successful launch of products. This role provides leadership in the development and implementation of analytical methods to characterize and ensure the quality of drug substances throughout the lifecycle of commercial manufacturing, with a focus on understanding and controlling critical quality attributes (CQAs) of the drug substance, adhering to all relevant regulatory standards and guidelines. In this role the incumbent will serve as the analytical lead and SME supporting the analytical launch readiness and testing support for commercial supply of glycoconjugate drug substances, including the testing of activated polysaccharide, conjugated material, and associated drug substances. Works in alignment with network organization to ensure on-time execution and appropriate planning for commercial lifecycle management 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 analytical and scientific rationale for Raw materials, DSI and DS testing 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 the analytical readiness and lifecycle management for commercial manufacturing. Reporting into the Senior Director for Global ASAT. The Director will collaborate on overall program strategy, with primary responsibility and accountability for the analytical leadership for commercial drug substance (DSI and DS) functions across the network. The Global MSAT (including ASAT) group is responsible for successfully and seamlessly transitioning the vaccine processes and analytical methods 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 aspects of analytical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS) and Drug Products (DP).
Essential Functions:
- DS Commercialization - Provide technical and scientific advice for internal and external stakeholders in support of the successful execution of launch plans and post-launch commercial activities. Manage and support the analytical control strategy with advanced state-of-the-art analytical equipment and technologies and routine trouble shooting. Life Cycle Management of process and product.
- Analytical validation and comparability - Develop and validate new analytical techniques and methods. Provide leadership for analytical validation and comparability activities. Effectively communicate the scientific and commercial rationale of analytical aspects to the Manufacturing organization for commercialization.
- Analytical Characterization - Provide analytical support activities related to method deve
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