Analyst II, Quality Control

$65,000 - $87,500/Yr

Resilience - East Norriton, PA

Full-time

East Norriton, PA

Chemical Manufacturing

About the position

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. The Analyst II, Quality Control position supports the Quality Control department, performing activities for routine testing of manufacturing release and stability samples of cell therapy products. The successful candidate 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.

Responsibilities

• Perform routine sample analysis in support of manufacturing release and stability activities
• Sample testing of CAR-T products using protein-based assays, molecular methods, and cellular assays
• Participate in method qualification/validation activities as assigned by QC management
• Analyze, document, and report experimental data in accordance with Resilience requirements
• Perform general laboratory maintenance activities per established schedule
• Maintain, calibrate, and operate analytical equipment; Qualify equipment related to testing, as necessary
• 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

Requirements

• Experience in mammalian cell culture
• Knowledge of general analytical methods
• GLP or GMP experience required
• Excellent interpersonal, verbal and written communication skills

Nice-to-haves

• BS in relevant discipline (immunology, cell biology, or related field) with 2-5 years relevant life science experience
• 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

Benefits

• Paid holidays
• Tuition reimbursement
• Flex time
• 401(k)