Manager External mRNA, Plasmid, and Small Molecule Manufacturing
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
For birds on our manufacturing team, patients and their families are counting on us to deliver for them, especially when it matters most. Come fly with us, this is your chance to help deliver un-incremental change in the emerging field of cell and gene therapy.
bluebird bio seeks an entrepreneurial manufacturing professional to help develop and execute the manufacturing strategy for all clinical development programs, as well as commercial supply. This role encompasses leading our external mRNA, plasmid, and small molecule manufacturing operations team and is ideally suited for a professional with strong management experience leading and evolving this function to support a broad portfolio of therapies. We are interested in candidates with a proven track-record of successfully integrating activities and perspectives across functions to achieve our goal to deliver therapies that transform the lives of patients.
- Work with the manufacturing operations team to support GMP production at CMO partners. Includes all activities from initial cell banking through final fill/finish.
- Build business processes and cross-functional relationships with bluebird and CMO partners.
- Ensure that all contractual obligations with our CMOs are met.
- Ensure on-time manufacturing and disposition of batches.
- Author quality system documentation to allow for GMP material release – including change controls, deviations, investigations, and CAPAs.
- Work with internal process development group to guide processes through characterization and validation for commercial supply.
- Work with internal process development group to tech transfer new processes into CMOs for GMP manufacture.
- Provide the technical expertise around manufacturing for technical reports and regulatory submissions.
- 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 and batch records as needed.
- Travel 10-20%
- A B.S. in engineering or life sciences, with 8+ year’s relevant industry experience. Advanced degrees desirable.
- Strong understanding of cGMPs is a must.
- Experience with producing and purifying biologics and/or commercial biologics manufacturing is strongly preferred.
- Highly organized and detailed oriented
- Experience with technology transfer or vendor management is preferred.
- Experience with process characterization and validation a plus.
- Should be highly motivated, collaborative, and be able to multitask in a fast-paced environment with changing priorities.
- Must be able to work both independently and as part of a multi-disciplinary team.
- Excellent communication skills and ability to influence across multiple functions.
- A passion for addressing the critical unmet medical needs of patients
- Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
About Bluebird Bio
About us 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.