QC Analyst I/II

Role Overview

The QC Analyst 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.

Key Responsibilities

• 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.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• 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.
• Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
• Job duties performed require routine exposure to and handling of biological materials and hazardous chemicals.

Requirements

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• 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 regulatory inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• This position may require up to 5% domestic or international travel as business demands.

Pay Range (Base Pay)

$68,045 — $89,308 USD

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.