Operations Director, CAR-T Manufacturing

Key Responsibilities

• Provide leadership to Operations Execution and Operations Support organizations, including operators, team leaders, supervisors, investigators and trainers, fostering a positive work environment that empowers employees and promotes high-performance teams.
• Provide leadership to drive effective communication and collaboration across all relevant groups to ensure robust production, testing and release of product to patients.
• Implement KPIs and monitor production processes to ensure efficiency, quality, and adherence to production schedules.
• Drive organizational transformation, operations ramp-up and facility approvals of state-of-the-art cell therapy manufacturing facilities.
• Maintain high standards of quality, compliance and safety through leadership by example.
• Build a strategy to develop existing talent through broadening experiences and commitment to delivery to the highest standards.
• Continue to build bench strength in the operations organization and ensure robust succession planning.
• Lead operational planning to manage capacity evolution and technology integration for clinical and commercial manufacturing.
• Drive high-quality and efficiency in management of non-conformances.
• Identify and contribute to the development and execution of initiatives that drive root cause identification, continuous improvement, cost reduction, and increased productivity throughout the manufacturing plant.
• Collaborate with the EHS and Quality teams to maintain high standards of compliance, product quality and workplace safety.
• Foster a culture of safety, compliance, and accountability across the manufacturing plant.
• Provide representation and leadership in regulatory inspections.

Qualifications

Education: A minimum of a Bachelor's degree is required, preferably with a focus in Science or Engineering. Master's or higher degree is preferred.

Experience and Skills

• Minimum 10 years of combined experience in cGMP manufacturing, operations management, technical transfer, process and equipment validation, quality management or related area is required.
• Experience working in a sterile biological/pharmaceutical/cell therapy manufacturing environment is required.
• Proven understanding of Good Manufacturing Practices (GMP's) is required.
• Strong people leadership including leading direct reports is required.
• Relationship/influencing savvy required.
• Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations required.
• Capable of dealing with ambiguity, working and leading in a matrix environment required.
• Capable of thriving in a fast-paced growth situation, with ability to adapt to changing environment required.
• Ability to balance day to day operational demands with the need to extend and improve the planning horizon to prepare strategically to manage future demands required.
• Ability to flex schedule to maintain off-hour communication and connection with 2nd shift employees as needed.
• Preferred: Lean and Six Sigma Certification.

Other: This position is located in Raritan New Jersey and may require up to 10% domestic and international travel.