Principal Scientist / Associate Director, Drug Substance CMC and External Manufacturing
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 bulk drug substance processes for protein-based biologic products. The candidate must also have experience succesfully managing third party contract development and manufactring partnerships and crafting and supporting the drug substance portions of US and international regulatory filings.
- Be the drug substance development and manufacturing subject matter expert in the CMC department. Liaise with corporate partners for all aspects of Cue Biopharma’s drug substance development and manufacturing programs.
- Manage the development and optimization of drug substance manufacturing processes at third party vendors and troubleshooting issues that arise.
- Serve as in-plant person for process development and manufacturing efforts with contract manufacturing organizations
- Optimize and further refine the existing drug substance manufacturing processes to support later stage clinical development.
- Design manufacturing processes to be compliant with global regulatory requirements. Remain current with upcoming regulatory trends so that the company’s manufacturing processes are compliant with FDA, EMA and global regulatory requirements.
- Draft the drug substance sections of INDs, IMDP and their amendments.
- BS in an applicable field of study with at least 12 years of industry experience, or MS in an applicable field of study with at least 8 years of industry experience, or PhD in an applicable field of study with at least 4 years of industry experience.
- Significant experience developing and troubleshooting biologics drug substance manufacturing processes required. Experience with Fc fusion proteins strongly preferred, experience with monoclonal antibodies preferred.
- Experience successfully managing CDMO relationships required.
- Ability to travel domestically and internationally to vendor and partner sites as needed to support product development activities and corporate partnerships.
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