Associate Analyst, Quality Control CAR-T

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

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Associate Analyst, Quality Control CAR-T to be in Raritan, NJ.

Purpose: The QC Associate Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 – 15 other Analysts within the functional laboratory of the Quality Control department.

You will be responsible for:

• Lab support and maintenance
• Sample handling (Supporting with the lifecycle of the samples outside of testing (Sample running-Disposal)
• Accountable for the review of equipment logbooks
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP laboratory.
• Ensure testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform peer review/approval of laboratory data.
• Apply electronic systems (LIMS, MES) for execution and documentation of testing.
• Supports process improvement teams.

Qualifications / Requirements:

Education:

• A minimum of an Associates’s Degree in Engineering, Science or equivalent technical field is required.

Experience and Skills:

Required:

• Minimum of (0-1) years of relevant work experience
• Knowledge of cGMP regulations, Good Documentation Practices (GDP) and FDA/EU guidance related to manufacturing of cell-based products is required.
• Experience within Biopharmaceutical or Pharmaceutical industry
• Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
• Experience with Quality Control document reviews and regulatory inspection processes
• Excellent written and verbal communication skills
• Candidates must be able to accommodate shift schedule. Shifts may include weekend and evening work as required by the manufacturing process.

Preferred:

• Experience in a Quality Control setting is preferred.
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Experience with LIMs and SAP or equivalent systems
• Basic understanding of routine and non-routine testing and sampling methods, techniques and related equipment is preferred.

Other:

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 8:00am - 6:00pm (Sunday - Wednesday), and provide occasional support on the weekends or 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 (col