MSAT Industrialization Leader, Drug Product Synthetics
Sanofi
August 23, 2026
On-site
Cambridge, MA
$148,500 - $214,500 USD yearly
Operations
Main Responsibilities
Process Design & Scale-up
- Define CMC development strategy for DP.
- Ensure DP process designs meet robustness, scalability, and manufacturability requirements.
- Lead manufacturability assessments; advise R&D on process design/control strategy with commercial constraints.
- Escalate unresolved process design risks to CMC governance.
- Support Technology Transfer and process validation readiness (RU/SU Process Leader).
- Provide process knowledge to support equipment design at receiving unit.
- Support validation strategy with Quality/Validation.
- Coordinate SMEs during on-site batch execution (tech batches, Eng runs, PPQ) and support process implementation at receiving launch unit.
Regulatory & Compliance
- Contribute to/review CMC dossier sections (process description, control strategy, validation, comparability).
- Represent M&S on the CMC team to reflect manufacturing feasibility/commercial constraints.
- Facilitate CMC–M&S interactions during tech transfer.
Knowledge & Communication
- Primary M&S representative in CMC development teams; integrate manufacturing considerations early.
- Present recommendations/progress reports to governance committees.
Commercial DP Manufacturing Support
- Provide input on change control; support process performance monitoring/analysis.
- Support CPV and continuous process improvement.
- Evaluate new technologies to improve robustness/efficiency/eco-design; anticipate lifecycle management needs.
Qualifications / Skills
- Master’s in Pharmaceutical Sciences/Life Sciences/Chemistry or related.
- 7+ years in Regulatory CMC and/or Process/Pharmaceutical Manufacturing Development/Analytical Science.
- Project management experience in complex/transversal environments.
- Understanding of current pharmaceutical scientific/regulatory and economic challenges.
- Process manufacturing, manufacturing improvements, integrated planning, pharmaceutical development.
- Process optimization, risk management, standards compliance, project management, strategy development, stakeholder communications, technology transfer, GMP compliance.
- Cross-functional teamwork and collaborative communication.
Benefits (if applicable)
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Location/Travel
- Cambridge, MA; regular travel to internal and contract sites required.
Process Design & Scale-up
- Define CMC development strategy for DP.
- Ensure DP process designs meet robustness, scalability, and manufacturability requirements.
- Lead manufacturability assessments; advise R&D on process design/control strategy with commercial constraints.
- Escalate unresolved process design risks to CMC governance.
- Support Technology Transfer and process validation readiness (RU/SU Process Leader).
- Provide process knowledge to support equipment design at receiving unit.
- Support validation strategy with Quality/Validation.
- Coordinate SMEs during on-site batch execution (tech batches, Eng runs, PPQ) and support process implementation at receiving launch unit.
Regulatory & Compliance
- Contribute to/review CMC dossier sections (process description, control strategy, validation, comparability).
- Represent M&S on the CMC team to reflect manufacturing feasibility/commercial constraints.
- Facilitate CMC–M&S interactions during tech transfer.
Knowledge & Communication
- Primary M&S representative in CMC development teams; integrate manufacturing considerations early.
- Present recommendations/progress reports to governance committees.
Commercial DP Manufacturing Support
- Provide input on change control; support process performance monitoring/analysis.
- Support CPV and continuous process improvement.
- Evaluate new technologies to improve robustness/efficiency/eco-design; anticipate lifecycle management needs.
Qualifications / Skills
- Master’s in Pharmaceutical Sciences/Life Sciences/Chemistry or related.
- 7+ years in Regulatory CMC and/or Process/Pharmaceutical Manufacturing Development/Analytical Science.
- Project management experience in complex/transversal environments.
- Understanding of current pharmaceutical scientific/regulatory and economic challenges.
- Process manufacturing, manufacturing improvements, integrated planning, pharmaceutical development.
- Process optimization, risk management, standards compliance, project management, strategy development, stakeholder communications, technology transfer, GMP compliance.
- Cross-functional teamwork and collaborative communication.
Benefits (if applicable)
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Location/Travel
- Cambridge, MA; regular travel to internal and contract sites required.