bluebird bio’s Cellular Process Development team for Sickle Cell Disease is a group of birds in Pharmaceutical Sciences designing processes to manufacture high quality stem cells in an innovative and scalable way for our patients. We develop the gene therapy manufacturing platform and chaperone it from pre-clinical to commercial manufacturing phases in collaboration with other teams across Pharmaceutical Sciences, Research and Clinical. With one approved product (Zynteglo™) and multiple clinical stage candidates, there is a wealth of growth opportunities for driven scientists to make a significant impact in patients’ lives. Come join our incredibly talented team of birds and learn more about how you can drive scientific advancements that ultimately serve patients with gene-modified stem cell products.
The sickle cell disease cellular process development team is responsible for developing and characterizing our cellular drug product processes and introducing new technologies for stem cell-based therapies. The focus of this position is to lead a small group and drive the development of an innovative and scalable manufacturing processes for our hematopoietic stem cell therapy for sickle cell disease. Candidates will have the opportunity to apply their experience and understanding of cell biology, cell culture, cell-based analytics, general laboratory techniques and/or cGMP operations in this role. Candidates should have a proven ability to innovate, collaborate, lead and drive scientific advancement in a fast-paced environment. Candidates should be passionate about developing innovative therapeutics that can transform patients’ lives.
About the role:
- Lead a small team to develop process improvements for unit operations for hematopoietic stem cell-based clinical and commercial programs
- Design and perform experiments involving the isolation, transduction, expansion and cryopreservation of gene modified hematopoietic stem cells for the treatment for hematological malignancies.
- Analyze data, interpret scientific results, author protocols and reports, and present scientific data to stakeholders.
- Independently manage and execute on key project workstreams.
- Work collaboratively with members from other groups including cell research, analytics, quality, and regulatory functions.
- Provide guidance to junior scientists in the design, execution and analysis of their work.
- Mentor junior scientists in their career development.
- Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation.
- Hands-on lab-based position requiring a flexible schedule based on experimental work (occasional weekend work may be required).
This is your dream job if you have:
- Ph.D. in Cell Biology, Molecular Biology, Bioengineering or related biological fields with a minimum of 2+ years (Ph.D.) or 6+ years (MS) of experience in the development of cellular and gene therapies is required.
- Strong background with stem cell biology is required.
- Expertise in aseptic tissue/cell culture is required.
- Previous experience managing/mentoring associate scientists in a laboratory setting is required.
- Strong writing, editing and presentation skills required.
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent organizational skills with an ability to embrace change, make decisions and multi-task in an extremely fast-paced environment to achieve deliverables in a timely fashion.
- 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.
Even better if you have:
- Experience with the culturing of primary human hematopoietic stem cells is preferred.
- Strong background in a variety of biological assays such as flow cytometry, qPCR, ELISA, FACS, and Luminex is preferred
- Experience with large scale, closed system manufacturing of therapeutic cell and/or gene therapy products from whole blood, apheresis, or bone marrow is preferred.
- Familiarity with common cellular therapy equipment such as Sepax, controlled rate freezers, and cell separation technologies (CliniMACS and other technologies) is desirable.
- Demonstrated experience with DOE models and background in using statistical software (JMP, Minitab, Prism or others) is desirable.
- Familiarity with risk-based assessments such as FMEA and designing, streamlining, and characterizing processes in the Quality by Design space are desirable.