Principal Scientist / Associate Director Analytical Outsourcing and Stability
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 analytical assays for the product release and stability testing of protein biologics drug substance and drug product. The successful candidate must also have experience establishing and maintaining LIMS based stability systems and performing statistical analysis and trending of stability data to support global regulatory filings.
- Be the analytical subject matter expert in the CMC department. Laisse with corporate partners for all aspects of Cue Biopharma’s analytical development and stability programs.
- Manage the development and optimization of analytical assays at third party vendors, troubleshooting analytical assay and stability issues that arise.
- Design stability programs to be compliant with ICH and global regulatory requirements. Remain versed in new regulations so that our regulatory filings remain globally compliant.
- Manage the trafficking of product release and stability samples between drug substance and drug product manufacturing sites and analytical testing facilities.
- Incorporate and maintain data from the stability program in the company’s LIMS system.
- Proactively monitor and trend stability data to determine product expiry to support clinical trials and identify issues that could potentially affect product quality.
- Establish product exposure limits to support clinical packaging and labeling activities and to set temperature excursion action limits to support the shipment of investigational drug supplies to clinical sites. Act as the subject matter expert to support and disposition clinical shipment temperature excursions.
- Optimize and further refine the existing assays to support later stage clinical development.
- Remain current with upcoming regulatory trends so that the company’s analytical assays are compliant with FDA, EMA and global regulatory requirements.
- Draft the analytical sections of INDs, IMDP and their amendments.
- BS in an applicable field of study with at least 12 years of 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, with expert knowledge in developing and troubleshooting analytical assays and managing stability programs required.
- Significant experience with biologics development required. Experience with Fc fusion proteins strongly preferred, experience with monoclonal antibodies preferred.
- Experience managing outsourced analytical development and stability studies required.
- Experience building and managing and trending LIMS based stability databases 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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