ABOUT THE FLOCK

The Senior Process Engineer I will be joining bluebird's Sickle Cell Disease Drug Product MSAT team, and will be a critical role focused on technology transfer and support of manufacturing of autologous gene therapies at CMOs. You'll have broad exposure to biologics manufacturing in a GMP setting, technology transfer, regulatory filings, and working within highly matrixed, cross-functional teams. This role spans technology transfer to CMOs, implementing process changes, authoring regulatory filings and information requests, leading technical investigations, and taking proactive measures to improve process performance and robustness.

HOW YOU’LL FLY

You'll help to bring more patients their bluebird days by:

• Serving as an accountable technical SME within a cross-functional team supporting external manufacturing of autologous gene therapies; collaborating with Manufacturing and Quality counterparts to ensure robust supply of drug product.
• Collaborating with MSAT counterparts at CMOs to deliver timely and accurate technical solutions to resolve investigations; reviewing process data and interfacing with process monitoring team to review trends to improve manufacturing performance and reliability.
• Leading technology transfers, implementing process changes, and supporting process validation.
• Writing and reviewing sections of regulatory filings and information requests, may support regulatory inspections.
• Leading/supporting complex investigations to deliver robust technical package for lot disposition.

WHAT YOU’LL BRING

You’re the bird we’re looking for if you have:

• A B.S. or M.S. in a scientific or engineering discipline and 6 years of experience, or a Ph.D. in a scientific or engineering discipline with 3 years of experience
• Experience working in cell or gene therapy manufacturing or in biologics manufacturing; Preferred experience working with CMOs
• Experience in leading product/process support within a GMP setting, performing investigations, technology transfer, implementing process changes, process validation, process monitoring, and routine clinical/commercial manufacturing support
• Experience in managing projects and leading cross-functional teams