Cellular Process Development Senior Associate Scientist I/II
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
The cellular process development team is responsible for developing cellular drug product processes and introducing new technologies for 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 a 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
HOW YOU’LL FLY
The cellular process development team is responsible for developing cellular drug product processes and introducing new technologies for 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 a 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.
- 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 (50%) that may require a flexible schedule based on experimental work (occasional weekend work may be required).
WHAT YOU’LL BRING
- 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).
- Experience authoring technical protocols, reports, and/or regulatory filing sections is required.
- 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 by applying Quality by Design principles is preferred.
- Strong background in a variety of biological assays including FACS 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.
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
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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