The QC Microbiology Specialist, CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Responsible for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
Create, review and approve relevant QC documents, SOP’s and WI’s.
Ensure microbiological control strategy is consistent with cGMP requirements.
Participate in training and delivery of Operations aseptic technique and microbiology awareness training program.
Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
Perform peer review/approval of laboratory data.
Utilize electronic systems (LIMS) for execution and documentation of testing.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Other duties will be assigned, as necessary.
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 routine and non-routine testing and sampling methods, techniques and related equipment is preferred
Detailed knowledge of the shop floor manufacturing process is preferred
Comprehensive knowledge of trending using statistical analysis is preferred
Ability to pay attention to details and follow the procedures is required
· 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.
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.