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**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an** Analyst, Quality Control Analytics - **This position will be located in Raritan, NJ! The role will operate under the following shift: 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.
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 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
- The anticipated base pay range for this position is $61,000 to $110,000 USD.
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.
#car-t
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$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