QC Microbiology Specialist I

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 second and 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

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required

A Minimum of 2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required

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

Knowledge of Aseptic Process Simulations 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

#LI-NP

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.