Director, Global Drug Substance Commercialization, Critical Raw Materials

Role Summary

The Director for Drug Substance (DS) Commercialization of Critical Raw Materials will lead and facilitate launch readiness and commercial supply of critical raw materials for production of eCRM and associated components for glycoconjugate vaccines. In this role the incumbent will serve as the technical lead and SME on biologic raw material processes. This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, launch supplies and post-launch process robustness initiatives. This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material manufacturing 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. Director for Global DS Commercialization, Protein. The Director will collaborate on overall program strategy, with primary responsibility and accountability for assigned critical raw material strategy, subject matter expertise and associated regulatory filings and supporting studies. 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, and Conjugation across all Drug Substances (DS). The range of activities will include technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle, etc. Location: San Carlos, CA.

Responsibilities

• DS Commercialization ‚Äì Provide strategic and scientific leadership for critical raw materials with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• Process robustness ‚Äì Continuously improve process understanding and process robustness using staff and laboratory resources across the organization 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 critical raw materials for pipeline products.
• Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics.
• Process validation and comparability - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for raw material processes to the Manufacturing organization for commercialization
• Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for DS processes to the Boards of Health for regulatory submissions for commercialization.
• 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.
• Leadership - Contribute as Strategy lead for assigned Critical Raw Materials and 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 Organic Chemistry, Biochemistry, Chemical or Biochemical Engineering, or related discipline with a minimum of 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A., or 16+ years for B.S./B.A.
• Extensive experience in scale-up, technology transfer, and relevant manufacturing process technologies /unit operations, including fermentation, recovery and purification at commercial scale. Experience with cell free protein synthesis and associated critical raw materials desired.
• Experience in manufacturing equipment specification/qualification and commercial manufacturing in a GMP environment is preferred. Experience working with Contract Manufacturing Organizations is desired.
• Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles.
• Able to leverage deep technical knowledge in a collaborative manner to troubleshoot technical challenges, establish strategic plans, and 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 directs activities to implement effective 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.