Job Information
J&J Family of Companies Analyst, Quality Control Analytics - CAR-T in Raritan, New Jersey
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T! This position will be located in Raritan, NJ!
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 https://www.jnj.com/.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!
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
Experience and Skills:
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 between the operational hours of 8 am - 6 pm, Wednesday - Saturday, and provide occasional support for other shifts
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
This position may require up to 10% of domestic and international travel
The salary for this position is anticipated to be between $62,000 and $95,000
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
#CAR-T