Senior Associate Scientist, Cellular Process Development
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
bluebird bio’s Cellular Process Development and Gene Editing team is a group of birds in Pharmaceutical Sciences designing processes to manufacture high quality messenger mRNA, reprogrammed T cells, and stem cells for our patients. We develop the gene therapy and gene editing manufacturing platforms and chaperone them from pre-clinical to commercial manufacturing phases in collaboration with other teams across Pharm Sci and Research. Come join our incredibly talented team of birds and learn more about how the work from this team has a significant impact in patient’s lives.
The cellular process development teams are responsible for developing cellular drug product processes and introducing new technologies for stem cell and T-cell based therapies. The focus of this position is to contribute to the development of manufacturing processes for our hematopoietic stem cell therapies. We are looking for a motivated scientist with the experience and drive to take ownership of important development, characterization, and process improvement projects. 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:
- Contribute to the development and characterization of engineered hematopoietic stem cell (HSC) processes to support manufacturing of both early and late stage products.
- Work collaboratively with members from other groups including cell research, analytics, quality, and regulatory functions.
- Develop experimental plans, author protocols and reports, interpret scientific results, and support CMC activities.
- Summarize and present scientific data to stakeholders.
- Develop process improvements for unit operations for HSC-based clinical and commercial programs.
- Independently manage and execute on key project workstreams.
- Provide critical lab support while working in a collaborative team environment.
- Hands-on lab-based position (70%) requiring a flexible schedule based on experimental work (occasional weekend work may be required).
- BS/MS in molecular biology, cell biology, biomedical engineering, chemical engineering, bioengineering, biochemistry or related degree with 4+ years of industry experience or relevant academic experience (BS) or 1+ years of industry experience (MS).
- Expertise in aseptic tissue/cell culture is required. Experience with the culturing of primary human hematopoietic stem cells is preferred.
- Familiarity with designing and characterizing processes in the Quality by Design space in a clinical setting.
- Strong background in a variety of biological assays such as FACS, ELISA, and qPCR 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 highly preferred.
- Familiarity with common cellular therapy equipment such as Sepax, controlled rate freezers, and cell separation technologies (CliniMACS and other technologies) is preferred.
- Demonstrated experience with DOE models and background in using statistical software (JMP, Minitab, Prism or others) is desirable.
- Experience with risk-based assessments such as RCA, FMEA, and streamlining processes is preferred.
- Ability to manage priorities and make decisions in a fast-paced environment to ensure deliverables are completed 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.
- Independently motivated, detail oriented and excellent 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.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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