Senior Manager, Global Drug Substance Commercialization, Critical Raw Materials

Role Summary

The Senior Manager 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 launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, launch supplies commercial supply of critical raw materials for production of eCRM and associated components for glycoconjugate vaccines 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 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 Senior Director for Global DS Commercialization, Protein. The Senior Manager will collaborate on overall program strategy, with primary responsibility for supporting development and execution of biologic critical raw material process strategy, troubleshooting and robustness study design and execution for critical raw materials.

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 by putting systems in place to monitor, trend, and optimize operations.
• Interface - Collaboration with cross-functional teams across the network, including Regulatory, Process Development, Quality, Supplies 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.
• 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. 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.
• 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., 8+ years for M.S./M.A., or 12+ 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.
• 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 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.

Skills

• Technical leadership in DS processes and launch readiness
• Cross-functional collaboration and regulatory communication
• Process validation, technology transfer, and robustness analysis
• Data analysis, troubleshooting, and decision making

Education

• As listed in Qualifications: degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline

Additional Requirements

• Travel: 10-30% travel required