Senior Analyst, Quality Control
About The Position
At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Senior Analyst I - QC Bioassay to join our Quality Control team. In this role, you will be establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products, playing a key part in advancing our mission and making a real difference.
Requirements
- BS with 5+ years of experience in a biotechnology discipline
- 5+ years of experience in a cGMP/GxP environment is preferred
- Hands on experience in ddPCR, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC methods
- Demonstrate a strong initiative and scientific leadership
- Direct experience in authoring and review/approval of SOPs
- Superb organizational, analytical, and communications skills and "do what it takes" attitude
- A passion for addressing the critical unmet medical needs of patients
- Self-directed individual who can work with limited direction in a fast-paced, goal-oriented environment
Responsibilities
- Perform cGMP analytical testing (ddPCR, qPCR, ELISA, and chromatography)
- Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.
- Author, review, and/or approve SOPs/policies and technical reports with general guidance
- Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
- Lead, author, perform, review, and/or approve equipment validations with minimal guidance.
- Implement, lead and/or support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
- Execute phase-appropriate test method validation protocols as needed
- Participate in providing the necessary information for regulatory filings and inspections.
- Lead and support CAPA/Continuous Improvement Initiatives
- Act as manager designee for quality document review and approval
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities
- A company that lives its values: Responsible, Responsive, Resilient, Respect
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
