Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The Process and Analytical Development organization at bluebird bio encompasses lentiviral vector, gene editing, and cellular drug product processing for oncology and severe genetic diseases. The cellular process development team is responsible for developing cellular drug product processes and introducing new technologies for stem cell and T cell therapies.
The focus of this position is to lead a team in the development, qualification and characterization of engineered T cell processes including the establishment of critical process parameters and controls for manufacturing. You will utilize your experience in a variety of cell based methods and strong understanding of tissue culture, cell biology, immunoassays, and general laboratory techniques, as well as pertinent experience in the transfer and application of technology in a cGMP environment.
About the role:
- Responsible for defining and driving the scientific strategy for engineered T cell process development efforts to support cGMP manufacturing for Phase I/II clinical trials.
- Act as a technical liaison between the research immunology and manufacturing operations functions
- Develop experimental plans, interpret scientific results, provide statistical analysis where appropriate, summarize and present scientific data and report progress on behalf of the team
- Point person for reviewing, writing, and editing of technical reports and regulatory documents to support IND and BLA filings.
- MS/Ph.D. in Cell Biology, Biochemical Engineering or related fields with a minimum of 5 years (Ph.D.) or 10 years (MS) of experience in the development of cellular and gene therapies is required
- Strong background in T cell biology and Immunology is required
- Strong background in a variety of biological assays such as FACS, ELISA, qPCR, Cytotoxicity, Proliferation, and Luminex is required
- Previous experience managing/mentoring associate scientists in a laboratory setting is required.
- Experience working with viral vectors for gene delivery and/or various gene editing techniques is required
- Must be familiar with large scale, closed system manufacturing of therapeutic cell and/or gene therapy products from whole blood, apheresis, or bone marrow
- Must be familiar with common cellular therapy equipment including but not limited to the following: Wave Bioreactors, Haemonetics Cell Saver 5, Elutra Cell Separator, Controlled rate freezers, LOVO cell washer, Multisizer 4 Coulter counters, CliniMACS.
- Good understanding of regulations and standards (GMP, GTP, AABB, FACT) for the processing of cellular therapy products for Phase I and Phase II clinical trials
- Demonstrated scientific aptitude through authorship of peer-reviewed publications
- Ability to manage priorities, and make decisions in a fast-paced environment to make sure deliverables are achieved in a timely fashion.
- Strong writing, editing and presentation skills required
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem solving ability
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
- Excellent communications 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 yourself
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.