Associate Manager, Plasmid Manufacturing Operations
About the role:
· Manage production programs for the company, as both the technical expert and the
· 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.
· 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.
· 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
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.