Senior Engineer, Global Drug Substance Commercialization, Protein at Vaxcyte

Summary:

The Senior Engineer for Drug Substance (DS) Commercialization has the accountability for launch readiness and commercial supply of 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 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, including person in plant support as required.
• 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.
• 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.

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., 10+ years for M.S./M.A., or 13+ 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.
• 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.