Join bluebird bio’s enthusiastic, collaborative team and contribute to the overall success of our novel gene therapy approach. We seek an experienced, energetic, and goal-oriented candidate looking to apply their current experience as a Quality Control professional to a growing Quality Sciences and Analytical Technology team. This role is a non-laboratory position that will support lentiviral vector technology transfers and lead implementation of microbial, safety, and analytical QC methods used for release testing of lentiviral vector for early and late-phase programs. The candidate will interface with contract manufacturers, contract test organizations as well as internal manufacturing, analytical, and regulatory teams to support process and analytical technical transfer. The candidate should have previous experience supporting implementation of QC methods through application of ICH, PDA, EP, and USP guidance, including but not limited to method validation and compendial method verification. The candidate should have previous experience in technical transfer within Quality Control or Manufacturing Sciences. This position will require approximately 5% travel.
About the Role:
- Lead the planning and coordination of microbial and analytical method implementation activities across a diverse CMO / CTL network supporting technical transfers or process improvements
- Support manufacturing process technical transfers through the development of sampling plans, in-process testing plans, including compendial method verifications for safety and viral detection methods.
- Own deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results obtained during technical transfers or process improvements across the bluebirdbio CMO / CTL network
- Lead QC operational efforts required for technical transfers of early- and late-phase processes, including the oversight of sample shipment, submitting legal contracts, and owning detailed project focused scope of work contracts.
- Author and review of internal and external technical and analytical protocols, reports and technical assessments (including various comparability assessments)
- Perform review and statistical analysis of data generated across the bluebirdbio CMO / CTL network during method lifecycle activities such as method validation, robustness studies and method comparability studies
- Perform gap assessments of analytical methods used throughout the CMO / CTL network to facilitate method harmonization against industry guidance documents
- BS with 10+ years, MS with 5+ years, or Ph.D. with 3+ years in a biotechnology discipline and in an industry setting. 5+ years of experience in a GMP environment is preferred
- Experience in GMP/GxP environment as well as an Analytical Development, Manufacturing Sciences or Quality Control unit is required
- Experience with QC activities required for technical transfers or manufacturing process improvements: release testing, method implementation, quality system management
- Proven track record and analytical experience within a QC environment related to mammalian cell culture, potency bioassays, ELISA, qPCR, flow cytometry, or liquid chromatography is preferred.
- In addition, experience with microbiology-based methods including general bioburden, sterility, and mycoplasma, as well as in-vitro adventitious agent methodologies is highly desirable.
- Proficient with Microsoft Word, Excel, PowerPoint and a statistical software (i.e. JMP, Prism)
- Strong initiative and scientific mindset that is motivated by analytical and operational challenges
- Passionate about working to critical unmet medical needs of patients
- Self-motivated and 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