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 Med. Tech, 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.

## The Role

We are searching for the best talent for an **Experienced Scientist, Biotherapeutics RD** to join our team in **Spring House, PA**. In this role, you will lead the manufacturing team responsible for producing autologous CAR

- T products for Phase 1/2a clinical trials. This is a hands-on leadership position where you will direct on-the-floor clinical cell therapy manufacturing operations in a c. GMP environment, ensuring adherence to manufacturing, safety, quality, and regulatory requirements while maintaining production schedules and supporting business goals.

### What You'll Do

- Support the Bio. TD CAR

- T organization in manufacturing CAR

- T products for clinical trials, working both independently and as part of a team to meet project timelines and objectives.

- Author SOPs and other technical documentation, and ensure the manufacturing facility adheres to c. GMP manufacturing and safety policies, quality systems, and c. GMP requirements while maintaining appropriate environmental control and using proven aseptic techniques.

- Effectively communicate operational status to stakeholders and management, and work closely with production staff to troubleshoot process and equipment issues in real time.

- Maintain the production schedule to meet business goals, and participate in internal meetings and audits.

- Review batch records and logbooks for completeness and accuracy, and successfully complete regulatory and job training requirements.

- Identify and implement process improvements related to safety, environmental performance, quality, and compliance within the change control system, assuring regulatory compliance and technical feasibility of proposed changes.

- Conduct training for new operations staff, and demonstrate expertise in c. GMPs, FDA regulations, and sterile/aseptic processing.

- Provide technical support for investigating and resolving deviations and atypical events utilizing phase-appropriate GMPs, and serve as a Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMA).

### Qualifications
• *Required:**

- Minimum of a Bachelor's Degree.

- Minimum of **5 years of experience** in CAR

- T or cell/gene therapy GMP manufacturing using single-use vessels and automated cell processing/expansion equipment.

- Experience leading and/or directing a team of operators to manufacture GMP CAR

- T or cell/gene therapy products.

- Experience coordinating manufacturing preparation activities and anticipating future processing needs.

- Knowledge of c. GMP regulations, FDA guidance, and other external regulatory authority requirements related to the manufacturing of cell-based products, including ATMPs and Annex 1.

- Experience conducting training for junior operators or new manufacturing staff, and experience with Aseptic Processing Simulation.

- Excellent problem-solving skills and the ability to resolve manufacturing issues in real time through coordination with management and QA.

- Excellent communication skills and experience with Microsoft Office software.

- Ability to actively drive innovation, think outside the box, and challenge others to do the same using a risk-based approach.
• *Preferred:**

- Experience with SAP, MES/PAS

- X, and LIMS.

- Experience leading projects and with change control.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

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