Senior Scientist/Principal Scientist,
Protein Purification Process Development
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, infectious disease and autoimmune disease. 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 purification processes for protein-based biologic products. The candidate must also 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 protein purification process development subject matter expert on the Protein Discovery team. Develop processes and generate documents including batch records, summary and technical reports.
- Design and execute experiments, collect and analyze data. Present process analyses, trends and summaries to the group in a timely manner.
- Generate, enhance and enrich process understanding knowledge. Initiate novel process/technology when applicable.
- Assist with cell culture and in-process analysis work when needed.
- Make strong technical contributions to cross functional development project teams to ensure efficient and timely execution of deliverables.
- 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 10 years of industry experience, or MS in an applicable field of study with at least 8 years of industry experience, or Ph.D. in an applicable field of study with at least 5 years of industry experience.
- Significant experience developing and troubleshooting protein purification processes.
- The successful candidate will be proficient in all unit operations and related software of DSP including chromatography, normal and tangential filtration instruments.
- Experience with AKTA Avant or Pure.
- DSP related process analytics experience in process performance, protein quality and residuals.
- Experience with Fc fusion proteins is strongly preferred as well as experience with monoclonal antibodies.
- Protein formulation experience is a plus. Knowledge of DS and DP process desired.
- DOE experience is strongly preferred.
- Experience with statistical software such as JMP or Minitab.
- Understanding of QbD is a plus.
- Cell culture experience or knowledge is a plus.
- cGMP collaboration experience preferred including experience with technical reviewing.
- Strong desire and curiosity to develop a novel class of therapeutic proteins.
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