MSAT Industrialization Leader, Drug Product Synthetics

Job Title:

MSAT Industrialization Leader, Drug Product Synthetics –

Location:

Cambridge, MA

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. The Lead supports the evolution of technical support when the product enters the commercial manufacturing phase. Acting as the voice of Manufacturing & Supply 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 ough 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.

• 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 of validation strategy with Quality and Validation
  • Coordinate technical SMEs during on‑site batch execution (tech batches, Engagement 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

• 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

• CMC Team
• Tech Transfer Governance
• Technical Review Board
• Technical Project Team
• CMC:
  Technical Review Meetings
• Scientific & Strategic Advisory Meeting (SSAM)
• CMC Board

• Master’s Degree in Pharmaceutical Sciences, Life Sciences, Chemistry or other related fields
• 7+ years of experience in 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…