Qc /ems Analyst

**Company Information**

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/EMS Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing and routine Environmental Monitoring sampling 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 and 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.
- Ensure QC testing and microbiological control strategy 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 the cGMP facility to manufacture products.
- Conduct analytical testing of utility and in-process samples submitted to the QC laboratories.
- 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.
- 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**:
**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 skills are required
- Comfortable with speaking and interacting with inspectors.
- This position may require occasional travel to partner sites as business demands (max 10%).

**Language(s)**:
Dutch

Technical English

LI-AG1

Legend Biotech maintains a drug-free workplace.