Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced analyst to lead the method lifecycle function of the newly formed raw materials team. This individual will be responsible for oversight of global raw materials laboratory methods, method verification/validation, author protocols/reports and sample coordination with Contract Manufacturing Organizations and Contract Testing Laboratories. This role will work directly with the Raw Materials manager, analytical development, and various contract testing organizations to assess raw material method requirements (compendial and non-compendial) and collaborate with raw material implementation.
About the Role:
Author/Review laboratory methods
Developing, verifying, validating analytical test methods to support raw materials testing at external contract labs (i.e HPLC, GC, ELISA, wet chemistry)
Author/review protocols and reports
Collaborate internally and externally to support the implementation of analytical methods and support life cycle management for raw materials
Manage the life cycle of raw materials documentations
Experience with method transfer, qualification, and validation (preferred)
Strong QC/cGMP knowledge and experience with 5+ years’ experience working in a pharmaceutical or biotechnology firm
Preferred knowledge of USP, EP, and JP monographs
Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
About Bluebird Bio
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.