Associate Manager, Late Stage Plasmids Mftg, Vector Manufacturing (Contract) (547)

Cambridge, MA

Associate Manager, Plasmid Manufacturing Operations
Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our
novel gene therapy approaches. bluebird bio seeks an outstanding scientist/manager to play an integral role in the collaborative management of third party CMOs producing multiple custom plasmid products. We seek candidates with proven ability to successfully work independently and collaboratively across QA, QC, PD, Supply Chain, and Regulatory functions to achieve optimized project plans, with the ultimate goal to deliver therapies that transform the lives of patients.

About the role:

·       Manage production programs for the company, as both the technical expert and the
operational lead.

·       Oversee GMP production activities at CMOs.

·       Author quality system documentation to allow for GMP-grade material release – including change controls and associated deviations, investigations, and CAPAs.

·       Author reports summarizing production processes and contribute to regulatory submissions

·       Work with supply chain function to ensure the supply of plasmids and small molecule raw materials.
Interface with internal process development groups to ensure material supply for all internal research and development activities.

·       Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs, MBRs, and operational protocols as needed.



About you:

·       BS in biological sciences or (bio)chemical engineering with 10+ years, MS with 8+ years, or a PhD with 4-6 + years of industrial experience in Phase 1 – Commercial Manufacturing.

·       Experience with microbial fermentation is preferred

·       Experience with GMP manufacturing is required

·       Experience with upstream and downstream processing for plasmids is highly preferred

·       Experience with vendor management is required

·       Experience with process characterization and validation is preferred.

·       Candidate should be highly motivated, have excellent organizational and communication skills, and be able to handle multiple projects in a fast-paced environment with changing priorities

·       Must be able to work both independently and as part of a multi-disciplinary team

·       Must be willing to have a flexible schedule based on experimental and company needs (including travel)

·       Excellent communication skills and ability to influence across multiple functions.

·       Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b



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