Quality Control Analyst, Critical Reagants

Biopharma Careers; Raritan (NJ); On-site; USD 65,000 - 105,000; Full time

Job summary

Johnson & Johnson is recruiting a Quality Control Analyst, CAR-T Critical Reagents, in Raritan, NJ. The role focuses on qualifying critical reagents for CAR-T QC labs, ensuring testing aligns with cGMP and GDP standards and regulatory requirements.

The qualified candidate will perform analytical testing, document results, assist in audits, and contribute to cross-functional QC initiatives. This is a Monday–Friday day shift with potential travel as needed.

Qualifications

• Minimum 2 years of relevant work experience.
• Knowledge of cGMP and GDP practices.
• Experience with qPCR, Flow Cytometry, ELISA, Cell Culture and/or potency assays.
• Excellent written and verbal communication skills.

Responsibilities

• Conduct analytical testing to qualify critical reagents used in CAR-T QC laboratories.
• Perform testing in compliance with GMP and GDP regulations.
• Document testing with eLIMS or paper records.
• Prepare qualification documentation and issue COA.
• Author and update SOPs, WIs, and Protocols.
• Support investigation records and CAPAs; assist internal audits.
• Represent QC in cross-functional meetings and provide input.

Skills

Two+ years experience

cGMP knowledge

GDP knowledge

qPCR

Flow Cytometry

ELISA

Cell Culture

Potency assays

Excellent communication

Education

Bachelor's degree in Biology/biochemistry/related field

Job description

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.

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Professional

All Job Posting Locations

Raritan, New Jersey, United States of America

Job Description

Johnson & Johnson is currently recruiting for a Quality Control Analyst, CAR-T Critical Reagents! This position will be located in Raritan, NJ.

Johnson & Johnson Innovative Medicine 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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in the manufacturing of our pharmaceutical products?

The Quality Control (QC) Analyst is responsible for preparing and conducting qualification testing of critical reagents used by the QC laboratories. They are responsible for ensuring testing is completed in adherence with all applicable procedures, standards, and GMP regulations.

Key Responsibilities

• Conduct analytical testing to qualify critical reagents used in the CAR-T QC laboratories
• Perform analytical testing in compliance with all applicable procedures, GMP, and GDP regulations
• Use eLIMS or paper records to document execution of testing
• Ensure a safe work environment by following guidelines in environmental, health, and safety regulations
• Perform peer review of laboratory data
• Prepare qualification documentation and issue Certificate of Analysis
• Author and updateSOPs, WIs, and Protocols using the Document Management System
• Support laboratory related investigation records and CAPAs
• Assist in the execution of internal audits
• Provide input to functional laboratory meetings
• Provide input and take actions as a QC representative at cross-functional meetings

Qualifications

Education

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

Experience and Skills

Required

• Minimum two (2) years of relevant work experience
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Excellent written and verbal communication skills

Preferred

• Experience in reagent qualification
• Experience in a Quality Control setting
• Experience within Biopharmaceutical or Pharmaceutical industry
• Basic knowledge of compendial (e.g., USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Work experience in Cell and/or Gene Therapy

Other

• This is Monday-Friday shift role, hours are 8AM-4PM, subject to be adjusted in the even of business need, occasional support on the weekends or holidays
• May require up to 10% domestic travel to regional sites

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. 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 . internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position

$65,000.00 - $104,650.00

Additional Description for Pay Transparency:

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 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