QC Analyst 1

Scope of Responsibilities

• Complete required read/understand courses, bench-work training and quality-controlled cGMP documentation requirements.
• Execute assigned analytical test methods, with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.
• Support analytical assay development ensuring they are robust enough for qualification, transition to quality control and successful implementation.
• Perform general laboratory tasks, including maintenance and troubleshooting of equipment.
• Maintain accurate and reliable records, electronic lab notebook entries, and all other pertinent documentation.
• Comply with all environmental health and safety standards.

Required Experiences

• Hands-on operation of UHPLC instrumentation (e.g., Agilent, Water’s platform) in a regulated or research setting.
• Working knowledge of molecular biology and/or biophysical characterization techniques applicable to DNA, RNA, or plasmid characterization.
• Hands-on experience with PCR platforms and related molecular assays.
• Working knowledge of proteomic or cell-based techniques used in CGT QC.
• Familiarity with compendial methods is a plus.

Minimum Qualification

QC Analyst I: Bachelors with minimum of 2 years or Masters with minimum of 1 year of relevant work experience, preferably in a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy. Demonstrate working knowledge of cGMP requirements. Ability to manage and prioritize tasks and projects, with the guidance of management. Strong verbal and written communication skills. Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful partner. Detail-oriented with strong problem solving and troubleshooting skills.