Senior Associate Scientist, Cellular Process Characterization (Full-time)
Novel gene therapy platform
With our lentiviral-based gene therapy and gene editing capabilities, we have built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapies for cancer. Our clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of transfusion-dependent ß-thalassemia (also known as ß-thalassemia major); a single-center Phase 1/2 study in France (HGB-205) for the treatment of transfusion-dependent ß-thalassemia or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of severe sickle cell disease (HGB-206). Our first immuno-oncology application will use CAR T cell technology to target B cell maturation antigen (BCMA) in multiple myeloma, and we anticipate treating the first patient in our Phase 1 study in the first quarter of 2016. We also have ongoing preclinical immuno-oncology programs targeting hematological and solid tumors, as well as discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The focus of this position is to provide support for late stage characterization studies of a stem cell gene therapy manufacturing process. We are looking for a Senior Associate Scientist with an analytical background and process characterization experience, preferably in cell and gene based therapies.
- Carry-out complex technical work related to stem cell biology, viral gene transfer, and molecular biology, including tissue culture, flow cytometry and RT-PCR.
- Clearly and concisely executes predetermined study protocols to support process characterization for cell-based gene therapy products.
- Performs large scale processing of apheresis collections using automated cell processing technology. Performs CD34+ selection on Sepax and ClinicMACS.
- Performs transduction of stem cells with lentiviral vectors in small and large scale format.
- Maintains accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation.
- Participates in writing/reviewing characterization plans and protocols, interpreting data and managing experimental timelines to meet corporate goals
- Must be willing to have a flexible schedule based on experimental and company needs (some weekend work will be required).
- BS or MS cell biology, immunology or related discipline with at least 5 years' experience in the biotechnology or pharmaceutical industry. Stem cell therapies is a plus.
- Demonstrated experience with process characterization, including application of principles of Quality by Design, such CQA, CPP and risk assessments
- Direct experience in authoring and review/approval of process characterization and validation protocols and reports
- Understanding of statistical concepts, such as DoE, to process characterization studies is desirable
- PCR skills and minimal Flow Cytometry assay exposure is preferred.
- Prior cGMP manufacturing experience for clinical-stage products, ideally supporting late stage clinical trials/product commercialization
- Proficiency in mammalian cell culture is mandatory
- Experience with cell processing automation is desirable
- This is a hands-on position requiring the execution of laboratory experiments
- Good understanding of applicable regulations for process characterization and validation
- Ability to work in a team environment, meet deadlines, and prioritize and balance work in an extremely fast-paced environment with changing priorities.
- Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
- Independently motivated, detail oriented and good problem solving ability.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
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