Scientist, Cell Process Development
Posted on Apr 5, 2021 by bluebird bio, Inc.
The Cellular Process Development team for Sickle Cell is focused on designing innovative and scalable processes to manufacture high quality stem cells for our patients. The team develops the gene therapy manufacturing platform and chaperones it from pre-clinical to commercial manufacturing phases in collaboration with other groups across Pharmaceutical Sciences, Research and Clinical. With one approved product (Zynteglo ) and multiple late-stage clinical candidates, there is a wealth of growth opportunities for driven scientists to transform the lives of patients. Come join our incredibly talented team of birds and help drive scientific advancements that ultimately serve patients with gene-modified stem cell products!
HOW YOU'LL FLY
Youll help to bring more patients their bluebird days by:
Leading a small team to develop process improvements for unit operations for hematopoietic stem cell-based clinical and commercial programs.
Designing and performing experiments involving the isolation, transduction, expansion and cryopreservation of gene modified hematopoietic stem cells for the treatment for hematological malignancies.
Analyzing data, interpret scientific results, author protocols and reports, and present scientific data to stakeholders.
Independently manage and execute on key project workstreams.
Working collaboratively with members from other groups including cell research, analytics, quality, and regulatory functions.
Providing guidance to junior scientists in the design, execution and analysis of their work and provide mentorship in their career development.
Maintaining accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation
This is a hands-on lab-based position requiring a flexible schedule based on experimental work (occasional weekend work may be required).
WHAT YOU'LL BRING
You're the bird we're looking for if you:
Have a recent Ph.D. in Cell Biology, Molecular Biology, Bioengineering or related biological fields or MS with 3-5 years of experience in the development of cellular and gene therapies is required
Strong background with stem cell biology is required
Previous experience managing/mentoring associate scientists in a laboratory setting is required.
Expertise in aseptic tissue/cell culture is required. 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 and a Broad knowledge of 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
Strong writing, editing and presentation skills required