Your mission

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.

Continuous Improvement:

• 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.

Team Leadership:

• 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