Senior Manager, Global Drug Substance Commercialization, Conjugation

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Summary:

The Senior Manager for Drug Substance (DS) Commercialization has the responsibility for launch readiness and commercial supply of the conjugate drug substance. The conjugate product strategy will transition from the Process Development organization to Manufacturing Science and Technology (MSAT) during late-stage product development.  This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.

This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for conjugation process to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will be highly skilled in written communication, especially in regard to authoring Health Authority submissions (IND/BLA). The role will also require the ability to interact effectively with people of diverse backgrounds and perspectives. The incumbent will also work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.

This position will be reporting into the Director for Global DS Commercialization, Conjugation. The Sr. Manager will collaborate on overall program strategy, with primary responsibility and accountability for the drug substance strategy. 

Manufacturing Science and Technology (MSAT) 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 Commercial Manufacturing and Supply Chain organization, MSAT 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 strategic and scientific leadership for polysaccharide to protein conjugation with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• Organization – Build a strong and highly-skilled team for the global network with special focus on manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.
• Process robustness – 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, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of the conjugate drug substance. 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 with the DS Commercialization lead and as member of the Global Manufacturing Operations, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients. Delegate effectively, celebrate diversity within the team, and manage team performance with a strong focus on colleague development.
• 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., 8+ years for M.S./M.A., or 12+ years for B.S./B.A.
• Experience in development, tech transfer, scale-up or production of polysaccharide/protein conjugate vaccines
• 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, especially in regards to authoring Health Authority submissions (IND/BLA) 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.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.