QC Analyst I/II

Legend Biotech US•Raritan, NJ

4d•$68,045 - $89,308•Onsite

About The Position

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

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.
Knowledge of Good Tissue Practices 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 regulatory inspectors.
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 solutions to problems by challenging the status quo and conventional thinking.

Nice To Haves

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 CAR-T QC test methods and related equipment is preferred.

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.

Benefits

Medical, dental, and vision insurance
401(k) retirement plan with a company match that vests fully on day one
Eight (8) weeks of paid parental leave after just three (3) months of employment
Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Voluntary commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs