The QC Analyst/Sr. 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.
1. Be 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 cleanroom environment.
2. Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
3. Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
4. Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
5. Perform peer review/approval of laboratory data.
6. Utilize electronic systems (LIMS) for execution and documentation of testing.
7. Create, review and approve relevant QC documents, SOP’s and WI’s.
8. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
9. Other duties will be assigned, as necessary.
Key Relationships Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
Experience: A Minimum of 2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
Key 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.
Legend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, 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.
Legend and Janssen are recruiting for a number of positions where qualified candidates can grow and be part of an exciting team and endeavor.
For general inquiries or interest, please contact:
Legend Biotech at firstname.lastname@example.org
About Legend Biotech
Legend Biotech is an integrated biopharmaceutical company specialized in the discovery and development of novel cell therapies, focused on hematologic malignancies, solid tumors, autoimmune and infectious diseases. Legend is a subsidiary of GenScript Biotech Corporation (HKEx: 1548), which operates in USA, Hong Kong, mainland China, and Ireland. Learn more at www.LegendBiotech.com.
Legend Biotech USA Inc. is a proud equal opportunity/affirmative ...action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech USA Inc. maintains a drug-free workplace.