Analyst, Quality Control Analytics (2 openings)

Johnson & Johnson Innovative Medicine•Raritan, NJ

2d•$66,000 - $106,950•Onsite

About The Position

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is hiring two Quality Control Analysts in Raritan, New Jersey. The role supports testing related to the manufacture of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. The position works Wednesday through Saturday, 2 p.m. to midnight, in 10-hour second-shift periods, and may involve up to 5% domestic travel to other sites or locations. The Analyst conducts analytical testing of raw material, utility, in-process, and final-product samples; ensures testing complies with procedures, standards, and current Good Manufacturing Practices; and collaborates with Process Development, Quality, and Operations to transfer processes and analytical testing to the cGMP facility. The role also involves reviewing laboratory data, using electronic systems to execute and document testing, and building, reviewing, and approving QC documents, SOPs, and work instructions. The role requires a bachelor's degree or equivalent university degree and at least two years of relevant work experience. Candidates should have knowledge of cGMP and Good Documentation Practices and experience with one or more cellular or molecular techniques, as well as manual sample processing. The physical requirements include lifting up to 20 pounds, standing or sitting for extended periods in a laboratory, visually inspecting materials, and documenting observations during laboratory testing.

Requirements

Bachelor’s degree or equivalent university degree.
At least 2 years of relevant work experience.
Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Experience performing one or more of the following cellular or molecular techniques: qPCR, ELISA, cell culture, or potency assays.
Experience with manual sample processing.
Excellent written and verbal communication skills.
Ability and flexibility to work 10-hour second-shift hours, Wednesday through Saturday, 2 p.m. to midnight.
Ability to lift up to 20 pounds, stand or sit for extended periods in a laboratory setting, visually inspect materials, and document observations during laboratory testing.
Ability to travel domestically to other sites or locations up to 5%.

Nice To Haves

A degree focused in Biology, Biochemistry, Microbiology, or a related scientific field.
Experience in a Quality Control setting.
Experience in the biopharmaceutical or pharmaceutical industry.
Work experience in cell and/or gene therapy or biologics.
Experience with LIMS and SAP or equivalent systems.

Responsibilities

Complete QC testing in compliance with applicable procedures, standards, and current Good Manufacturing Practices regulations.
Conduct analytical testing of raw material, utility, in-process, or final-product samples submitted to QC laboratories.
Work with Process Development, Quality, and Operations to transfer processes and analytical testing to the cGMP facility.
Perform peer review and approval of laboratory data.
Use electronic systems, including LIMS and iLAB, to execute and document testing.
Build, review, and approve relevant QC documents, SOPs, and work instructions.

Benefits

Company consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
120 hours of vacation per calendar year, subject to policy and date of hire.
40 hours of sick time per calendar year, with specified exceptions for employees residing in Colorado or Washington.
13 days of holiday pay, including floating holidays, per calendar year.
Up to 40 hours of Work, Personal and Family Time per calendar year.
480 hours of parental leave within one year of the birth, adoption, or foster care of a child.
Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
80 hours of caregiver leave in a 52-week rolling period.
32 hours of volunteer leave per calendar year.
80 hours of military spouse time off per calendar year.