Manager, External Manufacturing

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 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. They will manage the technical and operational activities including data management External manufacturing processes, analysis and reporting.

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.

REQUIRED 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 organization.

We group these behaviors into three pillars:

• HEAD
• Think Entrepreneurially
• 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 behaviors 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 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

Pay Range: $115,000 USD - $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 color, 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. This policy applies to hiring, training, promotion, compensation, disciplinary measures, access to facilities and programs, and all other personnel actions and conditions of employment. 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 program that will simultaneously serve the requirements of society, the law, sound business practices and individual dignity.

If you have questions or concerns about equal employment opportunities in the workplace, you are encouraged to bring these issues to the attention of the Head of Human Resources. We will not allow any form of retaliation against employees who raise issues of equal employment opportunity. To ensure our workplace is free of artificial barriers, violation of this policy may result in disciplinary action, up to and including termination.