Operations Director, CAR-T Manufacturing

About the role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• Job Function: Supply Chain Manufacturing
• Job Sub Function: Plant Management
• Job Category: People Leader

All Job Posting Locations: Raritan, New Jersey, United States of America

Summary

The CAR-T Operations Director is a member of the Raritan CAR-T site leadership team and plays a crucial role in leading the overall operations of the 24/7 manufacturing facility. Working closely with the Site General Manager, you will contribute to the efficient and effective functioning of the manufacturing site by ensuring compliance to cGMP practices while overseeing various aspects of production, personnel, and resource management. The position will lead a team of 6-8 direct reports and a broader organization of approximately 200 shift-based personnel.

The candidate must be comfortable to working in a matrixed environment, both within Johnson & Johnson and with our collaboration partner, Legend Biotech.

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.

Required

• 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.

Additional information

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

Preferred Skills

Agile Manufacturing, Business Planning, Developing Others, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Manufacturing Compliance, Manufacturing Safety, Organizational Project Management, Organizing, Plant Operations, Process Improvements, Strategic Supply Chain Management, Tactical Planning

The anticipated base pay range for this position is

$154,000.00 - $265,650.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year