Advanced Therapy Process Microbiologist

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.

Johnson & Johnson is currently recruiting for an Advanced Therapies Process Microbiologist. This position will be located in Raritan, NJ. The Advanced Therapies Process Microbiologist will join the Quality Assurance workstream and be closely connected with Operations and Quality Control work streams. You will have the opportunity to develop extensive knowledge in the highly innovative Advanced Therapy Medicinal Product manufacturing process and contribute to a significant impact on the health of our patients.

This position will be based at the CAR‑T and Lentiviral Vector manufacturing facilities in Raritan, NJ.

• Identify risks and opportunities in relation to process, contamination, and cross‑contamination associated with the manufacturing environment and drive follow‑up initiatives for improvement in close collaboration with operators, QA, QC and operations management.
• Develop, track, maintain, and deliver accurate data, metrics, and reports to support manufacturing environments locally and in collaboration with other global ATMP manufacturing sites.
• Review and approve non‑conformance investigations in your area of expertise.
• Manage, assess, and implement change controls and associated actions in your subject matter area.
• Explore opportunities to introduce emerging technological/digital solutions in Quality and drive these to implementation.
• Serve as an aseptic processing expert for Lentiviral Vector and train individuals on aseptic processing.
• Ensure compliance with all regulatory requirements particularly in the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements.
• Act as a spokesperson for your area during health care inspections.

Education: A minimum of a Bachelor’s degree is required with a focus in Biological Sciences such as Microbiology, Molecular Biology, Biochemistry, or a related field preferred.

Required

Experience and Skills:

• Minimum 2‑4 years working experience in a GMP regulated environment.
• Proven understanding of aseptic manufacturing, aseptic controls, and regulatory requirements.
• Strong proficiency and practical understanding of Microbiology.
• Excellent written and oral communication skills.

Preferred

Experience and Skills:

• Proficiency in analytical skills such as data analysis, basic statistics, and data visualization.
• Proficient with using Microsoft Office, Minitab, Tableau, or equivalents.
• Empowered professional who drives a Quality Mentality and can make well motivated pragmatic decisions on their own.
• Connect easily at all levels in the organization and lead by example.
• Demonstrate a steadfast work ethic and a passion for overcoming obstacles.

• This position is anticipated to have up to 10% travel.
• Business hours are generally Monday‑Friday 8:00 a.m. to 5:00 p.m., fully onsite at our Raritan, NJ office.

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. 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)).

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 Washington – 56 hours per calendar year. Holiday pay, including Floating…