Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases. Cue Biopharma is a high growth company and is listed on NASDAQ (CUE). The company is located in Cambridge, Massachusetts in the heart of the life sciences corridor.
Cue Biopharma is building a world-class team of highly motivated, dedicated scientists to help us advance our research and development programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.
The successful candidate will have a strong scientific background with hands-on experience developing and troubleshooting cell culture processes for protein-based biologic products. The candidate also must have experience in scaling up/down, tech transfer and in-depth understanding of cGMP in order to develop scalable, robust and effective processes.
- Serve as the USP development subject matter expert in the PD team. Develop processes and generate documents including batch records, summary, and technical reports.
- Design and execute experiments as well as collect and analyze data. Present process analysis, trending and summary to the group in a timely manner.
- Generate, enhance, and enrich process understanding knowledge. Initiate novel process / technology when applicable.
- Assist with DSP work when needed.
- Make strong technical contributions to cross functional development project teams to ensure efficient and timely execution of deliverable.
- Collaborate with other teams and CDMO partners in designing manufacturing processes and assist with tech transfer activities.
- Contribute to relevant sections of IND filings and other documentation.
- BS in an applicable field of study with at least 8 years of industry experience, or MS in an applicable field of study with at least 6 years of industry experience, or PhD in an applicable field of study with at least 2 years of industry experience.
- Significant experience developing and troubleshooting cell culture processes is required. The successful candidate will be proficient in all unit operations and related software of USP including aseptic operations, CO2 shakers, bioreactors, and filtration apparatus. USP related process analytics experience in cell growth and metabolites analysis required. Experience with Ambr system and or DasGip preferred. Experience with Fc fusion proteins strongly preferred, experience with monoclonal antibodies preferred.
- Experience in DOE strongly preferred. Experience with statistical software such as JMP or Minitab preferred. Understanding of QbD is a plus.
- DSP experience or knowledge is a plus.
- cGMP collaboration experience preferred. Experience in technical reviewing preferred.
- Desire and curiosity to develop a novel class of therapeutic proteins are highly preferred.
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