Senior Analyst II, Quality Control
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. For more information, please visit www.resilience.com Position Summary The Senior Analyst II, Quality Control - Flow Cytometry is to support our Quality Control department. The successful candidate will be responsible for performing routine testing for manufacturing release and stability samples of gene (viral vector) and cell therapy products. In this role, the Senior Analyst II will collaborate closely with Manufacturing and Quality Control Operations teams to ensure all required testing is completed accurately, on time, and in full compliance with established standard operating procedures and testing methods. This position reports to the Technical Lead Manager, Quality Control - Analytical, and is based at our East Norriton, PA facility.
Requirements
- Experience in mammalian cell culture.
- Knowledge of general analytical methods.
- Successful visual acuity test required for this role.
- Experience in Flow Cytometry.
Nice To Haves
- BS in relevant discipline (immunology, cell biology, or related field).
- 5+ years relevant life science experience.
- GMP experience preferred.
- Ability to thrive in ambiguous or complex situations.
- Highly motivated and self-directed.
- Thrives in matrix environment.
- Excellent interpersonal, verbal and written communication skills
Responsibilities
- Perform routine sample analysis in support of manufacturing release and stability activities.
- Sample testing of manufactured 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.
- Serve as owner of QC equipment and complete necessary owner tasks, as assigned by management.
- 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.
- Own, author, review/approve, and support QC change controls, deviations, and other quality records for the East Norriton site, as applicable.
- Investigate OOS or OOT events and develop/implement preventive and corrective actions.
- Mentor, coach and train Quality Control Associates.
- Completes qualified program requirements necessary to train other employees.
- Acts as liaison with Clients for site-specific Flow Cytometry, as needed.
- Other activities as assigned.
Benefits
- Resilience offers employees a robust total rewards program including 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
501-1,000 employees
