Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approach. This is an exciting hands-on role within our Quality Control team. We seek an experienced Quality Control professional to perform activities associated with QC stability programs for ancillary materials, starting materials and drug products in support of our early and late-phase clinical development to ensure successful clinical and commercial regulatory filings in the EU and US. You will provide significant contribution to the daily operations of the Quality Control laboratories.
This position requires partnering with various internal laboratory operations as well as a Contract Testing Organizations (CTO) network. The position requires a strong knowledge of cGMP/ICH/FDA/EU regulations.
About the position:
•Contribute to the operation of Stability programs across a multi-product portfolio
•Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for ancillary materials, starting materials and clinical drug product
•Utilize statistical software to trend stability data and establish retest and expiration dates
•Collaborate with Quality, internal functional areas, and CTOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
•Perform cross-functional laboratory investigations related to stability and laboratory operations
•Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA
•Bachelor’s degree in a scientific discipline, 5-10 years of related experience in QC GMP environment
•Strong knowledge of cGMP/ICH/FDA/EU stability regulations
•Solid understanding of statistical analysis as it relates to product stability trending and establishment of shelf life
•Experience with and strong understanding of statistical software packages such as JMP
•Superb communications—both written and oral skills – and strong interpersonal skills; experience with CTO/CMO interaction a plus
•Highly collaborative team player, with excellent organizational skills, ability to navigate and be successful in fast-paced and highly-matrixed work environment with changing priorities
•Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.