Senior Scientist, Protein Formulation 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 process matrix and parenteral formulations for protein-based biologic products. The candidate must also have experience in protein characterization, stability studies as well as an in-depth understanding of cGMP, to develop suitable formulations for therapeutics in our pipeline.
- Serve as the protein formulation development subject matter expert on the Protein Discovery team. Develop formulations and generate documents including lab records, summaries and technical reports.
- Design and execute experiments and collect and analyze data. Present process analysis, trends and summaries to the group in a timely manner.
- Generate, enhance and enrich process understanding knowledge. Initiate novel methods/technology when applicable.
- Develop formulation related assays 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 to ensure suitable formulation is developed for protein optimization and candidate selection. The successful candidate will assist tech transfer activities by providing technical input and related documentation.
- Contribute to relevant sections of IND filings and other documentation.
- 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, or equivalent.
- Significant experience developing protein formulation and process matrix is required. The successful candidate will be proficient in protein characterization and formulation screening.
- Knowledge and experience of DS and DP process desired.
- Experience in DOE is essential. Experience with statistical software such as JMP or Minitab preferred. Understanding of QbD is a plus.
- Experience or knowledge of protein purification process 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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