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Supervisor, External Manufacturing
@PIERRE FABRE PHARMACEUTICAL INC (USA)
[Hiring] Supervisor, External Manufacturing @PIERRE FABRE PHARMACEUTICAL INC (USA)
Mar 11, 2025 - PIERRE FABRE PHARMACEUTICAL INC (USA) is hiring a remote Supervisor, External Manufacturing. 💸 Salary: unspecified. 📍Location: USA.
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Role Description
The Supervisor, External Manufacturing, will be responsible for overseeing the day-to-day manufacturing operations at Contract Manufacturing Organizations (CMOs) involved in production. This role requires close coordination with CMO partners to ensure compliance with cGMP standards, effective execution of manufacturing processes, and adherence to project timelines. The Supervisor will play a critical role in ensuring successful product manufacturing and delivery while maintaining the highest quality standards.
- Oversee daily operations at CMO sites to ensure compliance with cGMP standards and adherence to established manufacturing protocols.
- Monitor production activities and provide on-the-floor support to resolve any issues.
- Ensure all manufacturing activities at CMO sites comply with regulatory and quality standards.
- Support the implementation of quality systems and controls to maintain product quality and consistency.
- Assist in managing deviations, investigations, and corrective and preventive action (CAPA) processes to ensure high-quality production outcomes.
- Collaborate with CMOs to implement corrective actions and drive continuous improvement.
- Maintain accurate and up-to-date documentation of manufacturing activities, including batch records, deviation reports, and process change controls.
- Prepare reports and presentations for internal and external stakeholders.
- Work closely with internal teams, including Quality, Regulatory, Supply Chain, and MS&T to align on production schedules and quality requirements.
- Participate in audits and inspections at CMO sites, providing support and documentation as needed.
- Identify opportunities for process improvements at CMO sites and collaborate with internal and external teams to implement changes.
- Assist in the technology transfer process, ensuring successful scale-up and implementation of manufacturing processes at CMO sites.
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field (e.g., Biotechnology, Chemical Engineering, Pharmaceutical Sciences).
- Minimum of 4-6 years of experience in biopharmaceutical manufacturing, with a focus on external or contract manufacturing.
- Experience in cell therapy manufacturing is highly desirable.
- Knowledge of cell therapy manufacturing processes, cGMP requirements, and regulatory standards.
- Experience with US and EU regulatory requirements for cell therapy products.
- Strong communication and interpersonal skills with the ability to build and maintain effective relationships with internal and external stakeholders.
- Strong organizational and problem-solving skills with the ability to manage multiple priorities and projects simultaneously.
- Ability to work effectively in a cross-functional team environment and collaborate with internal and external partners.
- Willingness to travel to CMO sites as needed to manage external manufacturing activities (up to 70%).
Preferred Qualifications
- Experience with cell or gene therapy manufacturing processes.
- Familiarity with regulatory requirements (FDA, EMA) for cell therapy products.
- Prior experience in a role within a cGMP manufacturing environment.
- Knowledge of process improvement methodologies (e.g., Lean, Six Sigma).
Benefits
- Competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more.
- Hybrid work policy.
- Generous PTO policy and company holidays.
- Paid parental leave.
- Discounts on our products.
- Learning and development opportunities.
- Access to mental health and wellness programs.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
unspecified
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 11, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
