Manager, External Manufacturing

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

Job summary

Collegium Pharmaceutical in Massachusetts is seeking a Manager to oversee External Manufacturing operations across the product portfolio, executing the manufacturing strategy and supporting Technical Operations initiatives. You will manage data, external manufacturing processes, analysis and reporting to ensure compliance with policies and regulations.

The role emphasizes partnerships with CMOs and cross-functional teams to drive process transfers, scale-up, validation and continued process

Qualifications

• Excellent communication skills (verbal and written) to collaborate with internal and external key stakeholders.
• Well organised – natural ability to think, communicate and conduct your work.
• Ability to navigate through ambiguity and rapid growth and adapt to change.

Responsibilities

• Operate with a quality‑first mindset while driving collaboration within the team.
• Manage technical lifecycle of products including technology transfers, scale‑up, process validation, and continued process verification.
• Oversee compliant execution of the tactical manufacturing strategy for external manufacturing partners.

Skills

Communication skills

Organisational skills

Adaptability

Cross-functional collaboration

Decision making

Education

Bachelor's degree in Chemical/Mechanical Engineering or Life Sciences

MS with 1-3 years of industry experience

Tools

Microsoft Office (Excel, Outlook, PowerPoint, Word)

Job description

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.

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

Position Overview

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. The Manager will manage the technical and operational activities including data management, external manufacturing processes, analysis and reporting.

Responsibilities

• Operate with a quality‑first mindset while driving innovative 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.
• Perform other administrative duties as required.
• Uphold and consistently demonstrate Collegium’s core values.
• Accountably deliver on team goals.
• Communicate clearly with explanations and clarifying questions.
• Develop skills within a narrow technical domain, with some independence.

Leadership Behaviors

At Collegium, how we achieve results is just as important as what we achieve. Our Leadership Behaviors define how we work, collaborate, and succeed as we continue to evolve as an organisation.

We group these behaviours into three pillars:

• HEAD
  • Think entrepreneurial
  • Take decisive action
  • Drive results
• HEART
  • Communicate effectively
  • Enable high performance
  • Collaborate with purpose
• GUTS
  • Take smart risks
  • Compete to win

Successful candidates will demonstrate these behaviours through their ability to challenge the status‑quo, build strong relationships, drive results, embrace change and contribute to a high‑performance culture.

Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or Life Sciences (preferably Chemistry) and 3‑5 years of industry experience, or an 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.
• Experience in a 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 organised – a natural ability to be organised 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.

Pay Range: $115,000 – $148,500 USD

Collegium is an equal‑opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment‑related decisions upon valid job‑related factors, without regard to age, national origin, citizenship status, ancestry, race or colour, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information or any other status protected by applicable federal, state or local law. By this policy, Collegium seeks to ensure that all employees have the opportunity to make their maximum contribution to Collegium and to their own career goals. This policy provides for an equal employment opportunity programme that will simultaneously serve the requirements of society, the law, sound business practices and individual dignity.