MSAT Industrialization Leader, Drug Product Synthetics

Sanofi•Cambridge, MA

1d•$148,500 - $214,500•Onsite

About The Position

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. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Requirements

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.
Process Manufacturing (Experienced/Advanced)
Manufacturing Process Improvements (Experienced/Advanced)
Integrated Planning (Experienced/Advanced)
Pharmaceutical Development (Experienced/Advanced depending on level)
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)
Cross-Functional Teamwork (Experienced/Advanced)
Collaborative Communications (Intermediate/Experienced)

Responsibilities

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
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
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
Serve as the primary M&S representative in CMC development teams, integrating manufacturing considerations early
Present technical recommendations and progress reports to governance committees
Provide technical input on change control management
Support process performance monitoring and analysis
Support continued process verification (CPV) and continuous process improvement activities
Evaluate new technologies to enhance process robustness, efficiency, and eco-design
Identify improvement opportunities and anticipate post-launch lifecycle management needs