Manager, External Manufacturing
About The Position
Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. This role is hybrid and requires the employee to be onsite in Stoughton, MA on Tuesday, Wednesday, and Thursday. The Manager will play a key role in the management of External Manufacturing operations across the Collegium Product portfolio to execute the manufacturing strategy and/or support Technical Operations initiatives. This role contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with Technical Operations policies, best industry standards and applicable regulations. They will manage the technical and operational activities including data management External manufacturing processes, analysis and reporting.
Requirements
- Bachelor’s degree in Chemical or Mechanical Engineering or Life Sciences (preferably Chemistry) and 3-5 years or MS with 1-3 years of industry experience.
- Considerable understanding of concepts and principles related to small molecule drug substance and/or solid dose drug product manufacturing, is required.
- Experience in GxP environment and working with external manufacturing partners.
- Excellent communication skills (verbal and written) to collaborate with internal and external key stakeholders across a cross-functional environment.
- Well organized – a natural ability to be organized in how you think, communicate and conduct your work.
- Ability to navigate through ambiguity and rapid growth and adapt to change.
- Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required
Responsibilities
- Operates with a Quality first mindset while driving innovative and collaboration within the working team.
- Accountable for technical lifecycle management of Collegium products including but not limited to technology transfers, scale-up, process validation, and continued process verification.
- Accountable for the compliant execution of the tactical manufacturing strategy of commercial product(s) for Collegium’s externally manufactured drug substances and drug products.
- Identify, coordinate, and perform the reviews for process performance and Key Performance Indicators at CMOs.
- Work closely with cross-functional and group team members to implement strategically aligned continuous improvements at CMOs.
- In close collaboration with Quality and Technical Operations functions coordinate investigations and troubleshooting efforts at CMOs.
- Frequently visit, maintain presence, and foster relationships at the Collegium external partners’ sites.
- Performs other administrative duties as required.
- Uphold and consistently demonstrate Collegium’s Core Values
- Role accountable for delivery of team goals
- Communicates clearly with explanations and clarifying questions.
- Develops skills within a narrow technical domain, some independence.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
