Senior Analyst, Quality Control
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a QC Analyst to support newly established commercial-level GMP testing laboratories for release and stability for multiple stages of our gene therapy products. This includes performing analytical methods, data review and trending, supporting continuous improvement of GMP systems to ensure a compliant Quality Control lab. The candidate will interface with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required. A cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role.
About the Role:
- Perform cGMP analytical testing (pH, osmolality, appearance, bioassay, cell culture, flow cytometry, qPCR, and ELISA)
- Review and evaluate raw data (peer review level)
- Author SOPs/Forms and technical reports with guidance
- Initiate laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with guidance
- Author, review, and execute equipment validations with guidance
- 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.
- Support CAPA/Continuous Improvement Initiatives.
- BS with 4 – 7+ years in a biotechnology discipline or MS 2 – 4+ years
- 4 – 7+ years of experience in a cGMP/GxP environment is preferred
- Preferable hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
- 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
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.