Job Title: MSAT Industrialization Leader, Drug Product Synthetics

• Location: Cambridge, MA

About the Job

The DP Industrialization Lead ensures that drug product processes developed in late-stage R&D are robust, scalable, and manufacturable at commercial scale, enabling their successful transfer to manufacturing. In addition, the Lead supports the evolution of technical support when the product enters the commercial manufacturing phase. Acting as the voice of Manufacturing & Supply (M&S) within CMC projects from Phase 2 Development to TT Kickoff, the Industrialization Lead safeguards process design integrity, anticipates commercial and lifecycle requirements, and ensures alignment with industrial standards, regardless of whether production takes place internally or at CDMOs. Through close collaboration with R&D (CMC), QA, RA, Engineering, Manufacturing and MSAT teams and the Tech Transfer Leader, the Industrialization Lead ensures the process is ready for transition from development to reliable commercial supply. Regular travel to internal and contract sites is required. In the post approval scope, the Leader will engage with M&S structure and MSAT Technical Product Teams to drive DP process support, yield and process improvements.

Main Responsibilities

Process Design & Scale-up

• Define CMC development strategy for DP
• Ensure process designs meet industrial robustness, scalability, and manufacturability requirements
• Lead manufacturability assessments and advise R&D on process design and control strategy with commercial constraints in mind
• Escalate unresolved process design risks to CMC governance
• Technology Transfer & Process Validation
• Support Technology Transfer as RU and/or SU Process Leader, ensuring manufacturing process is ready for Tech Transfer
• Provide process knowledge to support equipment design at receiving unit
• Support definition validation strategy with Quality and Validation
• Coordinate technical SMEs during on-site batch execution (tech batches, Eng runs, PPQ)
• Support process implementation at receiving launch unit as RUL
• Regulatory & Compliance
• Contribute to and review CMC dossier sections (process description, control strategy, validation, comparability)
• Represent M&S on the CMC team, ensuring submissions reflect manufacturing feasibility and commercial constraints
• Facilitate CMC-M&S interactions during the tech transfer process

Knowledge & Communication

• Serve as the primary M&S representative in CMC development teams, integrating manufacturing considerations early
• Present technical recommendations and progress reports to governance committees

Commercial DP Manufacturing Support

• Provide technical input on change control management
• Support process performance monitoring and analysis
• Support continued process verification (CPV) and continuous process improvement activities
• Innovation & Continuous Improvement
• Evaluate new technologies to enhance process robustness, efficiency, and eco-design
• Identify improvement opportunities and anticipate post-launch lifecycle management needs

Main Interfaces:

• CMC Project Team
• CMC DS sub-team
• CMC DP sub-team
• CMC platform
• M&S platform
• Tech Transfer Leader
• M&S Product Team
• MSAT Technical product team

Governance:

• CMC Team
• Tech Transfer Governance

• Technical Review Board
• Technical Project Team

CMC:

• Technical Review Meetings
• Scientific & Strategic Advisory Meeting (SSAM)
• CMC Board

About You

Basic Qualifications

• Masters Degree in Pharmaceutical Sciences, Life Sciences, Chemistry or other related fields.
• 7+ years of experience Regulatory CMC, Process / Pharmaceutical Manufacturing Development, Analytical Science, or other related fields
• Confirmed experience in project management, in working in project team and in complex environment (e.g., transversal assignments across different sites).
• Experience and understanding of current pharmaceutical environment trends including scientific and regulatory challenges.
• Experience and understanding of current pharmaceutical environment including the economic and regulatory challenges.

Technical Skills:

• Process Manufacturing (Experienced/Advanced)
• Manufacturing Process Improvements (Experienced/Advanced)
• Integrated Planning (Experienced/Advanced)
• Pharmaceutical Development (Experienced/Advanced depending on level)

Functional Skills:

• Process Optimization (Experienced/Advanced)
• Risk Management (Experienced/Advanced)
• Standards Compliance (Experienced/Advanced)
• Project Management (Experienced/Advanced)
• Strategy Development (Experienced/Advanced)
• Stakeholder Communications (Experienced/Advanced)
• Technology Transfer (Experienced/Advanced)
• GMP Compliance (Experienced/Advanced)

Transversal Skills:

• Cross-Functional Teamwork (Experienced/Advanced)
• Collaborative Communications (Intermediate/Experienced)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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