Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.
POSITION OVERVIEW
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.
RESPONSIBILITIES
- 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.
QUALIFICATIONS
- Bachelorβs degree in Chemical/Mechanical Engineering or Life Sciences (preferably Chemistry) with 3β5 years industry experience; or MS with 1β3 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).