Head of Manufacturing

Pierre Fabre , the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology.Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with " New Ways to Care ."Join Pierre Fabre USA to make a real impact in people's lives. Your purposeful career begins here.SUMMARY:We are seeking an experienced, highly motivated, and well-organized Manufacturing Leader to join a fast-paced, growing Tech Ops Organization. Reporting to the Head of Technical Operations, this position is responsible for build out and day to day leadership of the Pierre Fabre Pharmaceuticals US Manufacturing department. The Head of Manufacturing will be responsible for overseeing the strategic and operational aspects of manufacturing within our company, with a particular focus on managing relationships and performance with Contract Development and Manufacturing Organizations (CDMOs). This role involves ensuring the highest standards of quality, efficiency, and compliance while driving continuous improvement and managing against the approved budget. Responsibilities include contract negotiation and vendor relationship management for intermediates and Finished drug product. This role will work closely with Quality, Supply Chain, and Program management to ensure alignment and achievement of company goals and objectives. Additionally, this role is responsible for leading the MSAT function to ensure seamless technology transfers and real-time technical oversight of the production process. The successful candidate will be responsible for developing and executing strategic capacity plans to ensure the timely and efficient delivery of intermediates and finished cell therapy product.ESSENTIAL FUNCTIONS:Strategic Oversight:Develop and implement manufacturing strategies aligned with the company's goals and objectives.Lead the selection, management, and performance evaluation of CDMOs to ensure they meet contractual obligations and quality standards.Collaborate with senior leadership to define and prioritize manufacturing needs and capabilities.Operational Management:Oversee the day-to-day operations of manufacturing processes, ensuring adherence to regulatory requirements, quality standards, and operational efficiency.Manage the integration and coordination between in-house activities (production requests, material delivery, etc.) and CDMO activities to ensure seamless operations.Monitor and evaluate CDMO performance, addressing any issues related to quality, timelines, and cost.Quality and Compliance:Ensure all manufacturing activities comply with Good Manufacturing Practice (GMP), and other relevant regulatory guidelines.Monitor CDMO adherence to quality management systems and review/approve changes to any procedures/processes/materials/methods being implemented at CDMOs.Lead investigations and resolution of manufacturing deviations, non-conformances, and quality issues.Drive initiatives to optimize manufacturing processes, improve efficiency, and reduce costs.Foster a culture of innovation and continuous improvement within the manufacturing team and across CDMOs.Stay abreast of industry trends and technological advancements to leverage new opportunities for process enhancement.Cross-functional Collaboration:Work closely and proactively with Legal, Finance, HR, Regulatory affairs, and other departments to ensure alignment and support for manufacturing objectives.Coordinate with clinical and commercial teams to address manufacturing needs related to product development and market launch.Build and lead a high-performing manufacturing team, providing guidance, support, and professional development opportunities.Establish clear performance metrics and conduct regular performance reviews for direct reports.REQUIRED EDUCATION AND EXPERIENCE:Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or a related field. Advanced degree (MBA, MS, or PhD) preferred.Minimum of 15 years of experience in Pharma/Biotech manufacturing, with at least 10 years in a leadership role. Aseptic manufacturing and cell therapy experience preferred.Proven track record of managing CDMO relationships and overseeing complex manufacturing processes.Strong knowledge of GMP, and regulatory requirements related to aseptic manufacturing and cell therapy manufacturing.Exceptional leadership, communication, and interpersonal skills, with the ability to influence and collaborate across diverse teams.Excellent problem-solving skills and a proactive approach to managing challenges and driving improvements.WORK ENVIRONMENT:Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.LOCATION:Remote with some travel (25-35%). Routine travel to CDMOs and NJ office. Occasional travel to other company sites and external meetings as needed.Benefits of being a Pierre Fabre EmployeeJoin 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 has been recognized by Forbes as one of the " World's Best Employers " for the 3rd year running.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.

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