Manager, External Manufacturing

Hybrid:
Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.

The Manager will manage External Manufacturing operations across the Collegium Product portfolio to execute the manufacturing strategy and/or support Technical Operations initiatives. Ensures tasks comply with Technical Operations policies, best industry standards, and applicable regulations; manages technical/operational activities including data management, external manufacturing processes, analysis, and reporting.

• Operate with a Quality-first mindset while driving innovation and collaboration.
• Lead technical lifecycle management (technology transfers, scale-up, process validation, continued process verification).
• Ensure compliant execution of tactical manufacturing strategy for externally manufactured drug substances and drug products.
• Identify, coordinate, and perform reviews for process performance and KPIs at CMOs.
• Implement continuous improvements at CMOs with cross-functional teams.
• Coordinate investigations and troubleshooting with Quality and Technical Operations.
• Frequently visit CMO/external partner sites and foster relationships.
• Perform required administrative duties.
• Uphold Core Values; deliver team goals.
• Communicate clearly with explanations and clarifying questions.
• Develop skills within a narrow technical domain with some independence.

• Bachelor’s degree in Chemical/Mechanical Engineering or Life Sciences (preferably Chemistry) with 3–5 years industry experience; or MS with 1–3 years.
• Strong knowledge of small-molecule drug substance and/or solid dose manufacturing.
• GxP experience and experience with external manufacturing partners.
• Excellent verbal/written communication; cross-functional stakeholder collaboration.
• Strong organization; ability to adapt to ambiguity and rapid change.
• Proficient with Microsoft Office (Excel, Outlook, PowerPoint, Word).

Pay Range: $115,000 USD - $148,500 USD