My client seeks an Analyst II, Quality Control - Product Testing, supporting the Quality Control department. The successful candidate will perform activities for routine testing of manufacturing release and stability samples of gene (viral vector) and cell therapy products.
The QC Analyst II will partner with Manufacturing and QC operations teams to ensure that all required testing is performed, meeting all partner needs in compliance with standard operating procedures and testing methods.
Job Responsibilities
Perform routine sample analysis in support of manufacturing release and stability activities
Sample testing of lentiviral vector and CAR-T products using protein-based assays, molecular methods, and cellular assays
Participate in method qualification/validation activities as necessary
Analyze, document, and report experimental data in accordance with company requirements
Maintain, calibrate, and operate analytical equipment
Qualify equipment related to testing
Perform method transfer and qualification activities
Document work in accordance with cGMPs, established business processes and applicable SOPs
Review data, identify discrepancies, and escalate issues to management
Author SOPs, methods, protocols, training materials, and reports in alignment with applicable cGMPs, business standards, and intended use
Investigate OOS or OOT events and develop/implement preventive and corrective actions
Other activities as assigned
Minimum Experience, Education & Qualifications
BS in relevant discipline (immunology, cell biology, or related field)
2-5 years relevant life science experience
Experience in mammalian cell culture
Experience in flow cytometry, PCR/qPCR/ddPCR, cell-based assays is highly preferred
Knowledge of general analytical methods
GLP or GMP experience required
Other Preferred Qualifications and Ideal Personal Characteristics:
Background in Cell Therapy/Gene Therapy
Experience in a laboratory environment
Ability to thrive in ambiguous or complex situations
Highly motivated and self-directed
Thrives in matrix environment
Excellent interpersonal, verbal and written communication skills