QC Analyst, Microbiology (CAR-T)

Johnson & Johnson•Raritan, NJ

1d•Onsite

About The Position

Johnson & Johnson is seeking a QC Analyst, Microbiology - CAR-T to join their team in Raritan, NJ. This role is responsible for performing QC testing and environmental monitoring for the manufacturing of autologous CAR-T products for clinical trials and commercial operations within a cGMP cleanroom or laboratory setting. The position operates on a Wednesday-Saturday, 1st shift schedule.

Requirements

A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required or 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.
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 (Endotoxin, EM, Bioburden).
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 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 or equivalent.
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.

Responsibilities

Completing QC testing and environmental monitoring related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Creating, reviewing, and approving QC documents including SOPs, WIs, and FRMs.
Supporting Aseptic Process Simulations and visual inspections.
Maintaining Grade B/C gowning.
Performing Environmental Monitoring and Critical Utility Sampling.
Performing release assays: Mycoplasma, Endotoxin, and Sterility (BAC-T).
Performing Growth promotion, Subculture, Gram Stain, and Microbial Identifications.
Performing peer review/approval of laboratory data.
Utilizing electronic systems for execution and documentation of testing.
Performing tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
Training QC analysts, operators, or other employees.
Working in a collaborative team setting with quality counterparts including Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
Being available to work off hours or on weekends, dependent on business needs.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
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