Operations Manager, CAR-T

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 https://www.jnj.com

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Operations Manager, CAR-T to join our Team in Raritan, NJ.

Are you interested in joining a team that is passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today. To support the global

CAR-T program, Johnson & Johnson Innovative Medicine is rapidly growing its manufacturing and laboratory capabilities. This position offers a perfect environment to transform CAR-T Cell Therapy manufacturing and the underlying supply chain systems, into something unique given the limited amount of Cell Therapy manufacturers worldwide. Apply today for this exciting chance to be part of the #CAR-T team!

The Raritan CAR-T facility manufactures a personalized autologous cell therapy product, in collaboration with our partner Legend Biotech, that is significantly improving the lives of patients with Multiple Myeloma. The manufacturing of this CAR-T therapy takes several days through various processing steps and quality control procedures.

Key Responsibilities:

• Leads production unit responsible for portions of the personalized cell therapy process, supporting both clinical and commercial patients, in a cleanroom environment. 

• Fosters a culture of safety and compliance according to current Good Manufacturing Practices (cGMP) requirements in manufacturing operations.

• Leads supervisor and operations personnel working in the Value Stream, including hiring and developing talent at all levels to grow within and beyond their current roles.

• Partner with all functions including Quality, Maintenance, Planning and Operations Support to ensure flawless execution of daily production schedules.

• Lead completion of objectives and projects.

• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.

• Monitor plant performance metrics and lead plant operating review meetings.

• Maintain permanent inspection readiness and actively support regulatory inspections.

• Promote a mentality of continuous improvement, problem solving, and problem prevention.

Qualifications:

Education:

• A minimum of a Bachelor’s degree is required, preferably with a focus in Science or Engineering.

Experience and Skills:

Required:

• Minimum (6) years of manufacturing experience in a Good Manufacturing Practices (GMP) environment

• Experience managing direct reports / teams.

• Proficiency in English (verbal and written), strong communication skills and the ability to influence in all directions

• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint and Outlook)

Preferred:

• Experience working in sterile biological / pharmaceutical manufacturing environments

• Experience with continuous improvement, Lean/6-Sigma Manufacturing

• Experience with electronic batch records

• Good analytical and problem-solving abilities thriving in a fast-paced work environment

Other:

• This role may requ