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Scientist II, Global Drug Substance Commercialization Protein
VaxcyteSan Carlos, United Statesfull_timeVerifiedPosted 29 Jul 2024
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:
*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.
*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.
*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 Scientist II for Drug Substance (DS) Commercialization has the responsibility for supporting launch readiness and commercial supply of the carrier protein (eCRM) and associated raw materials. During late-stage product development the eCRM product strategy will transition from the Process Development organization to the DS Commercialization group within Manufacturing Science and Technology (MSAT). 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 will utilize engineering principles and professional experience to effectively communicate the scientific and commercial rationale for eCRM 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 Sr. Manager for Global DS Commercialization. The Scientist II will collaborate on program strategy for the eCRM process and support scale-up, validation, and commercial lifecycle activities, with primary responsibility for the recovery and downstream purification operations. 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, 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.
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:
*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.
*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.
*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 Scientist II for Drug Substance (DS) Commercialization has the responsibility for supporting launch readiness and commercial supply of the carrier protein (eCRM) and associated raw materials. During late-stage product development the eCRM product strategy will transition from the Process Development organization to the DS Commercialization group within Manufacturing Science and Technology (MSAT). 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 will utilize engineering principles and professional experience to effectively communicate the scientific and commercial rationale for eCRM 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 Sr. Manager for Global DS Commercialization. The Scientist II will collaborate on program strategy for the eCRM process and support scale-up, validation, and commercial lifecycle activities, with primary responsibility for the recovery and downstream purification operations. 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, 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.
Essential Functions:
- DS Commercialization – Provide strategic and scientific support for eCRM and associated raw materials with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
- Organization – Collaborate across the global network with special focus on protein recovery and purification manufacturing processes.
- 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, CMC, Quality, Supply Chain, Procurement, and Process Engineering, 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 int
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