Lead Analyst, Quality Control Microbiology (Durham, NC)
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced QC Microbiology Senior Analyst to support establishing new GMP Microbiology testing laboratories, facility qualification, and release and stability testing for our gene therapy and immune oncology products. This includes performing analytical methods, data review and trending, implementation of GMP operational support systems ensuring a compliant Quality Control lab. The candidate will interface directly with multiple functions including Quality Assurance, Manufacturing, and Facilities. A strong cGMP, operational and technical background in Microbiology will be utilized in the role. This position will require hands on laboratory time.
About the Role:
About the Role:
- Perform cGMP Microbiological testing
- Perform and train others on environmental monitoring
- Review and evaluate raw data from a peer or technical review level of methods, as well as sample authorization.
- Author, review, and/or approve SOPs/policies and technical reports
- Lead laboratory deviations and investigations, 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)
- 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
- BS with 5+ years or MS with 3+ years experience in a Microbiology laboratory is required
- 5+ years of experience in a cGMP environment is preferred
- Hands on experience with environmental monitoring, facility qualification, bioburden, endotoxin, and other Microbiological methods is necessary
- Direct experience in authoring and review/approval of SOPs is strongly desired
- Demonstrate a strong initiative and scientific leadership
- 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 is able to work with limited direction in a fast-paced, goal-oriented environment
- Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself