Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The Manufacturing Science and Technology (MSAT) organization at bluebird bio is a team of scientists and engineers responsible for the technical support and oversight of late stage and commercial manufacturing processes for small molecules, oligonucleotides, lentiviral-based vectors and stem and immune cell-based therapies across internal and external manufacturing sites.
The focus of the MSAT Vector Process Engineer role is to lead a team of process engineers supporting late-stage and commercial lentiviral vector manufacturing processes through the planning, execution and analysis of at-scale and scale-down experiments to enhance process understanding and performance. The chosen candidate will have the opportunity to participate in the transfer, improvement, and evaluation of manufacturing activities for our rare disease and oncology pipelines. We seek candidates with proven ability to successfully work independently and collaboratively across functions to enhance product quality, quantity, and process efficiency. We are passionate about transforming the lives of patients, incredibly cool science, and bird puns.
About the role:
- A lab-based leadership position with a focus on lentiviral vector manufacturing technology to support investigations and continuous improvement initiatives, including oversight of the planning, execution, and analysis of experiments at manufacturing scale and using qualified scale-down models.
- Authors and reviews technical documentation related to internal and external manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
- Works cross-functionally across Program/CMC Teams, Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide technical assessment for engineering and process changes in a cGMP environment.
- Proactively identify and propose mitigations to risks as part of continuous improvement in alignment with regulatory and commercial manufacturing requirements.
- Delivers technical CMC input for regulatory interactions related to lentiviral vector manufacturing processes including IND submissions/amendments, marketing authorization submissions, and inspections
- BS/MS/PhD degree in chemical engineering with focus in biotechnology or biopharmaceuticals
- 8+/5+/2+ years' experience in late-stage biopharmaceutical development;
- Experience in leading a high performing team of technical staff as direct reports
- A successful candidate will possess excellent communication skills, including writing and oral presentation, and the flexibility to move between the planning and execution of each required function, as needed.
- General knowledge of process development and pharmaceutical manufacturing for biologics including upstream and downstream unit operations.
- Demonstrated expertise in mammalian cell culture.
- Experience with quality systems including Deviations, CAPA, and Change control is preferred.
- Prior experience in the gene therapy field is a plus, but not required.
- Track record of completing deliverables within specified timelines
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
- Above all else, an absolute passion for addressing the critical unmet needs of patients.