Quality Control Analyst, Critical Reagants

Johnson & Johnson Innovative Medicine and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

The Quality Control (QC) Analyst is responsible for preparing and conducting qualification testing of critical reagents used by the QC laboratories. They are responsible for ensuring testing is completed in adherence with all applicable procedures, standards, and GMP regulations.

Key Responsibilities:

• Conduct analytical testing to qualify critical reagents used in the CAR-T QC laboratories
• Perform analytical testing in compliance with all applicable procedures, GMP, and GDP regulations
• Use eLIMS or paper records to document execution of testing
• Ensure a safe work environment by following guidelines in environmental, health, and safety regulations
• Perform peer review of laboratory data
• Prepare qualification documentation and issue Certificate of Analysis
• Author and update SOPs, WIs, and Protocols using the Document Management System
• Support laboratory related investigation records and CAPAs
• Assist in the execution of internal audits
• Provide input to functional laboratory meetings
• Provide input and take actions as a QC representative at cross-functional meetings

Qualifications:

Education:

Minimum of a Bachelor's or equivalent University Degree required; focused degree in Biology, Biochemistry, or related scientific field is preferred

Experience and Skills:

Required:

• Minimum two (2) years of relevant work experience
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Excellent written and verbal communication skills

Preferred:

• Experience in reagent qualification
• Experience in a Quality Control setting
• Experience within Biopharmaceutical or Pharmaceutical industry
• Basic knowledge of compendial (e.g., USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Work experience in Cell and/or Gene Therapy

Other:

• This is Monday-Friday shift role, hours are 8AM-4PM, subject to be adjusted in the event of business need, occasional support on the weekends or holidays
• May require up to 10% domestic travel to regional sites