QC Microbiology Supervisor- CAR-T

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•$79,000 - $127,650•Onsite

About The Position

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. Johnson & Johnson is currently recruiting for a QC Microbiology Supervisor- CAR-T! This position will be located in Raritan, NJ. The role will fall under the following shift: Sunday-Wednesday 2pm-1am. Johnson & Johnson Innovative Medicine (JJIM), and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. The Quality Control Microbiology department supports manufacturing actitives while overseeing the laboratory assays. Role Objective The Supervisor, QC Microbiology CAR-T Manufacturing is responsible for technical execution of day-to day activities for the Quality Control Microbiology laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They are responsible for carrying out duties in adherence to all local, state, and federal regulations and guidelines (FDA, EPA, and OSHA) as well as all company and site policies and procedures. In partnership with the QC Supervisors, they also provide QC mentorship and support throughout the JJIM Supply Chain (JSC) for new initiatives, projects, product transfers, and regulatory inspections.

Requirements

Aseptic processing in ISO 5 clean room and biosafety cabinets.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products.
Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment for microbiological testing/assays.
Detailed knowledge of the shop floor manufacturing process.
Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC Microbiology.
Comprehensive knowledge of trending using statistical analysis.
Ability to pay attention to details and follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Good written and verbal communication skills are required.
Proficiency in computer systems including LIMS.
The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Experience leading, coaching, or supervising direct or indirect personnel or teams.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required.
A minimum of four (4) years of relevant work experience years within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in a Quality Control setting.
Direct or in-direct management experience.

Responsibilities

Create, review and approve relevant QC documents, SOP’s and WI’s.
Utilize electronic systems (eLIMS) for execution and documentation of testing.
Manages a team of analysts within the Micro QC department based on assigned work, direction, coaching and developing capabilities.
Responsible for test method verification, qualification and/or transfer activities in the Micro QC lab.
Participate in CAR-T manufacturing facility commissioning and qualification.
Responsible for the approval of environmental monitoring data.
Provide oversight of gown qualification/requalification of personnel and assist staff in cleanroom as needed.
Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
Initiate and approve quality investigations, CAPAs, and change controls related to microbiology.
Schedule and review all microbiology testing not limited to: compressed gas sampling, bioburden, Routine Environmental Monitoring, sterility, mycoplasma and endotoxin testing.
Support Aseptic Process Simulations and visual inspection of components.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements

Benefits

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)).
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year