mRNA Associate Director, cGMP Strategic Outsourcing Initiatives
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This individual will help develop the outsourcing strategy for end-to-end cGMP clinical manufacturing required by Sanofi’s mRNA Center of Excellence (CoE). Additionally, they will assist in coordinating “make/buy” analyses and outsourcing partner decisions with Vaccine Industrial Affairs (VIA) for commercial manufacturing, ensuring a seamless Phase III to commercial transition. While focused primarily on external sourcing of mRNA drug substance, lipid nanoparticle (LNP) drug product, and final drug product, scope will include assisting Analytical Sciences with administrative aspects of outsourcing work to contract laboratories. It will also include coordination with the Raw Materials Program and working with the supply chain and external manufacturing groups in establishing partnerships with external vendors for upstream components (eg, critical starting materials and reagents such as linearized plasmid, lipids, critical enzymes, and other custom reagents and materials).
Serving in an outsourcing manager role, this individual will coordinate the key steps in establishing partnerships with external vendors (ie, confirming needs for outsourcing, identifying the short list of potential partners, business vetting/qualification, leading the CDA/RPI/RPF/RFQ process, selecting the vendor, developing the SOW with the technical lead, confirming stakeholder alignment, ensuring Legal/Procurement negotiate/execute a suitable agreement in a timely manner, ensuring a QTA is created as needed, executing purchase order). This individual will also assist in establishing/maintaining an outsourcing database through proactive partner search/screening efforts, collating important metrics and milestones from these partnerships, and capturing learnings from past efforts. The cGMP Strategic Outsourcing Initiatives and Projects group will normally not be involved with project execution; however, they will support long-term relationship management for preferred/strategic partners. During the transfer of oversight of newly established capacity to the project execution group, this individual will provide project management leadership to ensure a smooth and efficient transition to the project execution group. Project management responsibilities include team definition including senior leadership buy in, project governance establishment, schedule development and project team meeting coordination.
The individual will take a holistic approach to developing the mRNA CoE’s future outsourcing strategy, considering supply risks, cost of goods, logistics and distribution, stability, intellectual property, competitive market space, and operational efficiencies. The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry. This role is part of a team focused on development and manufacturing of a novel mRNA technology along with all of the supporting functions. This role requires technical knowledge, preferably with biologics, lipid-based, and/or particle-based drug delivery systems, and knowledge of analytical characterization of complex formulations. The role also requires both organizational and external vendor management skills, as well as general operational knowledge for chemical synthesis, pharmaceutical processing product packaging, vial filling, lyophilization, distribution, facilities, and other business operations.
Assist in developing and executing a long-range, stage-appropriate CMO/CRO outsourcing strategy consistent with the mRNA CoE’s long-range forecasts and vision, ensuring appropriate collaboration with VIA for a seamless Phase III to commercial transition.
Help conduct “make versus buy” analyses based on sound business cases to confirm if outsourcing is needed.
When needed, clearly delineate outsourcing capabilities/services required.
Establish appropriate partnerships with external entities, CMO, CDMO, CRO for operations relating to mRNA CoE portfolio and platform support.
Align and communicate with other business functions, coordinating and implementing CMO/CRO Strategy plans to be consistent with interdepartmental needs.
Coordinate with technical line function SMEs to create SOWs, tech transfer plans, etc.
Lead coordination across BD/Alliance Management, Legal, Procurement, Finance, Quality, etc. to create, negotiate and execute required outsourcing-related agreements (eg, CDAs, MSAs, QTAs).
Administer RFI/RFPs, purchase orders, etc. associated with outsourcing workflows.
Create and maintain an outsourcing database that is fit-for-purpose for mRNA CoE, leveraging Sanofi databases when possible.
Conduct strategic outsourcing scouting by keeping abreast of industry developments, proactively meeting with external vendors to understand and assess their capabilities and capturing learnings from ongoing efforts.
Organize, evaluate, and communicate data in an effective and scientific manner
Advanced professional with 10+ years of relevant experience in the biopharmaceutical industry.
College or advanced degree in chemical, biomedical, biochemical, or process engineering, chemistry, materials sciences, or formulation sciences, coupled with an understanding of analytical chemistry.
Professional development and/or advanced degree in business or management is not required but preferred.
Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices.
Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 – Q12) and compliance with the same.
Proven track record developing internal and/or external manufacturing strategies to support pre-clinical through commercial programs.
Experienced in contract negotiations (i.e. supply agreements).
Proven technical experience in the development, manufacture and delivery of small molecule, biologic, and advanced therapy assets.
Solid understanding of multi-modality (small molecule and complex biologic or gene therapy) product development from pre-clinical through to commercial.
Proven track record of matrix management for complex programs
Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication.
Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support mRNA CoE’s scientific and business goals.
Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment
Experience in CMO search, evaluation, selection, and management and familiarity with request for information and request for proposal processes.
Familiar with current issues and Regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production.
Ability to travel (U.S./ Int’l) on occasion (<15% expected)
Work is primarily performed in a hybrid/office environment with light physical demands and normal exposure to everyday risks and discomfort requiring common safety precautions.
This job description is intended to describe the general nature and level of the work being performed by employees in the position. It is not intended to be a complete list of all responsibilities, duties, and skills for the position. The Company reserves the right at all times, in its sole discretion, to add or subtract duties and responsibilities, as it deems necessary.
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