Senior Engineer, Global Drug Substance Commercialization, Protein

Role Summary

The Senior Engineer for Drug Substance (DS) Commercialization has 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.

Responsibilities

• DS Commercialization ‚Äì 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 ‚Äì 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.

Qualifications

• 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.

Education

• Constellation: Not specified

Additional Requirements

• Reports to: Senior Director, Global DS Commercialization Lead, Protein
• Location: San Carlos, CA