External Manufacturing Manager — Drug Substances & Ops

Collegium Pharmaceutical, Inc.; Stoughton (MA); Hybrid; USD 115,000 - 148,500; Full time

Job summary

Collegium Pharmaceutical, Inc. is seeking a Manager to lead External Manufacturing activities in its Stoughton, MA operations.

The role supports the manufacturing strategy across the Collegium product portfolio, managing technical lifecycle activities and ensuring compliance with regulations and company policies. Based in a hybrid role onsite Tuesday, Wednesday and Thursday in Stoughton, MA, you will drive collaboration with CMOs, oversee data and KPI reporting, and coordinate investigations

Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or Life Sciences, with 3–5 years of industry experience.
• Experience in small molecule drug substance and/or solid dose drug product manufacturing.
• GxP environment experience and experience with external manufacturing partners.
• Excellent verbal and written communication to liaise with internal and external stakeholders.
• Well organized and able to maintain clarity in communication and work.
• Ability to navigate ambiguity and rapid growth.
• Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word).

Responsibilities

• Operate with a quality-first mindset while driving collaboration.
• Manage technical lifecycle of products including tech transfers, scale-up, process validation, and continued process verification.
• Execute compliant manufacturing strategy for externally manufactured substances and products.
• Identify and review process performance and KPIs at CMOs.
• Work with cross-functional teams to implement continuous improvements at CMOs.
• Coordinate investigations and troubleshooting at CMOs in collaboration with Quality and Technical Operations.
• Visit and maintain relationships at external partner sites.
• Perform other administrative duties as required.
• Uphold Collegium’s Core Values.
• Deliver team goals.
• Communicate clearly with explanations and clarifying questions.
• Develop skills within a narrow technical domain with some independence.

Skills

GxP experience

Small molecule manufacturing

Communication skills

Organization

Adaptability

MS Office

Education

Bachelor’s degree in Chemical or Mechanical Engineering or Life Sciences

Job description

Collegium Pharmaceutical, Inc. is seeking a Manager to lead External Manufacturing activities in its Stoughton, MA operations.

The role supports the manufacturing strategy across the Collegium product portfolio, managing technical lifecycle activities and ensuring compliance with regulations and company policies. Based in a hybrid role onsite Tuesday, Wednesday and Thursday in Stoughton, MA, you will drive collaboration with CMOs, oversee data and KPI reporting, and coordinate investigations