Analyst, Quality Control Analytics (2 openings)

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Raritan (NJ); On-site; USD 61,000 - 110,000; Full time

Job summary

Johnson & Johnson, Janssen Pharmaceuticals, Inc. in partnership with Johnson & Johnson, is recruiting two Analyst, Quality Control Analytics for work in Raritan, NJ. The role supports QC testing of autologous CAR-T products in a controlled cGMP environment.

Responsibilities include analytical testing of materials, data integrity, and interdepartmental coordination to transfer testing to manufacturing. Second shift (Wed-Sat, 2pm–12am) with up to 5% travel may be required.

Qualifications

• Bachelor’s or equivalent degree required.
• Minimum 2 years of relevant work experience.
• Knowledge of cGMP and GDP practices.
• Experience with cellular/molecular techniques (qPCR, ELISA, cell culture, and/or potency assays).
• Experience with manual sample processing and lab documentation.

Responsibilities

• Ensure testing complies with cGMP, GDP, and applicable procedures.
• Perform analytical testing of raw materials, in-process, and final product samples.
• Collaborate with Process Development, Quality, and Operations to transfer methods to the cGMP facility.
• Peer review/approve laboratory data.
• Use LIMS/iLAB for testing execution and documentation; build and review QC documents and SOPs.

Skills

cGMP

GDP

qPCR

ELISA

Cell Culture

Potency assays

Manual processing

Communication

Education

Bachelor’s degree or equivalent

Tools

LIMS

SAP

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Professional

Job Posting Location

Raritan, New Jersey, United States of America

Job Description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for two Analyst, Quality Control Analytics. This position will be located in Raritan, NJ, with a work shift of Wednesday- Saturday 2pm-12am. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 Analyst is responsible for completing QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities

• Ensure testing is completed in compliance with all applicable procedures, standards, and current Good Manufacturing Practices regulations.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Perform peer review/approval of laboratory data.
• Use electronic systems (LIMS, iLAB) for execution and documentation of testing.
• Build, review, and approve relevant QC documents, SOPs, and WIs.

Qualifications

Education

• Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, or related scientific field is preferred.

Required

• Minimum 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 and/or molecular based techniques: qPCR, ELISA, Cell Culture, and/or Potency assays
• Experience with Manual Sample Processing
• Excellent written and verbal communication skills

Preferred

• Experience in a Quality Control setting
• Experience within Biopharmaceutical or Pharmaceutical industry
• Work experience in Cell and/or Gene Therapy or Biologics
• Experience with LIMs and SAP or equivalent systems

Other

• Requires ability and flexibility to work 10-hour shifts Second Shift (2PM-12AM) Weds-Sat.
• Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing
• Requires up to 5% domestic travel to other sites/locations

Pay

The anticipated base pay range for this position is $61,000 to $110,000 USD.

Equal Opportunity Statement

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. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

Accommodations

If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers

Pay Transparency & 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)).
• Salary: $66,000.00 - $106,950.00
• 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits