Supervisor, External Manufacturing

Your mission

At Pierre Fabre Pharmaceuticals Inc. our mission is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better. We are the US pharmaceutical subsidiary of Pierre Fabre Laboratories Worldwide, a foundation-owned company with 7 decades of impact. Pierre Fabre Laboratories is a truly global healthcare company, established in 43 countries, with products distributed in 119 territories across the globe. Pierre Fabre's foundation ownership enhances our ability to focus on creating long-term value for patients.

Building on the legacy of Pierre Fabre Laboratories, innovation is our life blood and patient experience drives everything we do. We aspire to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.

SUMMARY:

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.

ESSENTIAL FUNCTIONS:

1. Daily Operations Oversight: 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.
2. Quality Assurance and Compliance: 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.
3. Deviation and CAPA Management: 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.
4. Documentation and Reporting: 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.
5. Cross-Functional Collaboration: Work closely with internal teams, including Quality, Regulatory, Supply Chain, and MS&T to align on production schedules and quality requirements. Ensure effective communication and collaboration across all functions to support successful manufacturing outcomes.
6. Audit and Inspection Support: Participate in audits and inspections at CMO sites, providing support and documentation as needed. Ensure all findings are addressed and corrective actions are implemented in a timely manner.
7. Continuous Improvement: Identify opportunities for process improvements at CMO sites and collaborate with internal and external teams to implement changes. Drive a culture of continuous improvement and operational excellence.
8. Technology Transfer: Assist in the technology transfer process, ensuring successful scale-up and implementation of manufacturing processes at CMO sites. Collaborate with internal and external teams to ensure seamless integration and execution.

REQUIRED EDUCATION AND EXPERIENCE:

1. Education: Bachelor's degree in Life Sciences, Engineering, or a related field. (e.g., Biotechnology, Chemical Engineering, Pharmaceutical Sciences).
2. Experience: 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.
3. Technical Expertise: Knowledge of cell therapy manufacturing processes, cGMP requirements, and regulatory standards. Experience with US and EU regulatory requirements for cell therapy products.
4. Communication and Interpersonal Skills: Strong communication and interpersonal skills with the ability to build and maintain effective relationships with internal and external stakeholders.
5. Organizational and Problem-Solving Skills: Strong organizational and problem-solving skills with the ability to manage multiple priorities and projects simultaneously.
6. Team Collaboration: Ability to work effectively in a cross-functional team environment and collaborate with internal and external partners.
7. Travel: Willingness to travel to CMO sites as needed to manage external manufacturing activities. Up to 70%.

Preferred Qualifications:

1. Experience cell or gene therapy manufacturing processes.
2. Familiarity with regulatory requirements (FDA, EMA) for cell therapy products.
3. Prior experience in a role within a cGMP manufacturing environment.
4. Knowledge of process improvement methodologies (e.g., Lean, Six Sigma).

WORK ENVIRONMENT:

1. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Benefits of being a Pierre Fabre Employee:

Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees.

Pierre Fabre:

Pierre Fabre has been recognized by Forbes as one of the World's Best Employers for the 3rd year running.

True to My Nature:

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Who you are:

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.

About us:

With nearly 10,000 employees worldwide, we design and develop innovative solutions that contribute to the well-being of all, from health to beauty, combining the best of medical and naturalness.

We achieve this by cooperating with health care professionals, our long-standing trusted partners, by drawing relentless inspiration from nature; and by placing pharmaceutical ethics at the very heart of our operations.

We focus our research and manufacturing activities in South-West France where our roots lie.

We are proud to belong to a public-interest organization, the Pierre Fabre Foundation, which is dedicated to improving access to high-quality health care and medication in the poorest countries.