Resilience 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.
The position will be in our East Norriton, PA facility and will support weekend testing requirements.
- 4 x 10 Sunday to Wednesday; 3pm to 1am
- 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 Resilience 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
- BS in relevant discipline (immunology, cell biology, or related field)
- 2-5 years relevant life science experience
- Experience in mammalian cell culture
- Knowledge of general analytical methods
- GLP or GMP experience required
- 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
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $72,000.00 - $91,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.