QC Analyst III

Legend Biotech is seeking a QC Analyst III as part of the Quality team based in Raritan, NJ
.

The QC Analyst III 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.

• 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.

• 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.
• Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
• Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
• Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
• Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
• Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
• Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
• Employs good project management principles to appropriately align time, resources, and budgets.
• Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
• Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
• Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
• Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
• Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change.
• Generates new…