What are the responsibilities and job description for the QC Microbiology Specialist position at Legend Biotech US?
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 and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a QC Microbiology Specialist, Lentivirus CAR-T Manufacturing as part of the Quality team based in Raritan, NJ. The current openings are on the third shift .
Role Overview
The QC Microbiology Specialist, Lentivirus Vector (LVV) CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the LVV facility to support clinical trials and commercial operations in a controlled GMP environment.
Major Responsibilities
- Responsible for performing routine EM sampling, including viable / non-viable air and surface sampling, related to the manufacturing of LVV used for autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment
- Responsible for performing compressed gas sampling in the manufacturing LVV facility
- Work with Process Development team, Quality and Operations organization to successfully transfer LVV manufacturing process to cGMP facility
- Create, review and approve relevant QC documents, SOP's and WI's
- 5Ensure microbiological control strategy is consistent with cGMP requirements
- Participate in training and delivery of Operations aseptic technique and microbiology awareness training program
- Support Aseptic Process Simulations and visual inspection of components
- 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
Key Relationships
Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical / Process Development
Requirements
LI-JR
Li-Onsite
Legend Biotech 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 maintains a drug-free workplace.
