QC Analyst

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.  

Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Role Overview

The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial  operations in a controlled GMP environment. 

Major Responsibilities:

• Responsible for the completion of QC testing related to the manufacturing of autologous CART products for clinical trials and commercial operation in a controlled cGMP cleanroom  environment.

• Ensure testing is completed in compliance with all applicable procedures, standards and GMP  regulations.

• Work with Process Development team, Quality and Operations organization to successfully  transfer process/analytical testing to cGMP facility to manufacture products.

• Conduct analytical testing of raw material/utility, in-process, or final product samples  submitted to the QC laboratories.

• Perform peer review/approval of laboratory data.

• Utilize electronic systems (LIMS) for execution and documentation of testing.

• Create, review and approve relevant QC documents, SOP’s and WI’s.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP  requirements.

• Other duties will be assigned, as necessary

Qualification

Education:

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical  discipline is required or relevant years of experience within the pharmaceutical  industry.

Experience:

A minimum of 1-2 years relevant work experience is required. It is preferable that  the candidate have experience working in an aseptic manufacturing facility,  preferably in quality assurance, manufacturing compliance, clinical quality, or cell  therapy. 

Capabilities, Knowledge, and skills:

• Experience in a Quality Control setting is preferred.

• Experience with aseptic processing in ISO 5 clean room and biosafety  cabinets is required.

• Knowledge of cGMP regulations and FDA/EU guidance related to  manufacturing of cell-based products is required.

• Knowledge of Good Tissue Practices is required.

• Detailed knowledge of CAR-T QC test methods and related equipment is  preferred

• Excellent written and oral communication skill are required

• Candidates must be able to accommodate shift schedule. Shifts include  routine weekend and evening work as required by the manufacturing  process.

• Candidates must be able to accommodate unplanned overtime (including  nights and weekends) on little to no prior notice.

• The candidate must be highly organized and capable of working in a team  environment with a positive attitude under some supervision.

• Comfortable with speaking and interacting with inspectors.

• This position may require occasional travel to partner sites in NJ or PA as  business demands.

• This position may require up to 10% domestic or international travel as  business demands. 

Language(s):

Dutch and/or English