Senior Engineer, Global Drug Substance Commercialization, Protein

Senior Engineer, Global Drug Substance Commercialization, Protein

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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 Engineer 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 planning and execution by bringing best-practices and developing and executing technical deliverables in support of regulatory filings, facility readiness, and launch supplies.

This position will be reporting into the Senior Director for Global DS Commercialization, Protein. The Sr. Engineer will collaborate on overall program strategy, with primary responsibility and accountability for the scale down model strategy execution, gap closure and robustness studies, person-in-plant SME support for manufacturing campaigns, and robustness study design and execution for protein and associated 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.

Essential Functions

• DS Commercialization – Provide engineering leadership for eCRM and associated raw materials with internal and external stakeholders and ensure successful execution of technical deliverables in support of launch plans and post-launch commercial activities.
• Process robustness – Continuously improve process understanding and process robustness by identifying and closing technical gaps 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…