Supervising Staff Scientist, Process Development

Position Summary

We are seeking an innovative and highly motivated Supervising Staff Scientist with expertise in cell therapy process development and people management. This individual will interface across many parts of the organization and contribute significantly to the development of our advanced cell therapy manufacturing platform. The primary focus of this position is to provide organizational leadership and technical insight into the onboarding and optimization of new cell therapy processes to expand and drive continuous improvement of the Cellares platform. The ideal candidate will be an adept leader and cross-functional collaborator with demonstrated expertise in developing robust autologous and allogeneic cell therapy processes. The role requires close collaboration internally and with external partners. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• Lead multifaceted process development efforts to drive continuous improvement of the Cellares platform
• Interface directly with external partners to facilitate technology transfer, data reviews, and overall program governance
• Develop and manage program timelines for process development
• Perform gap assessments and develop thorough development plans, statements of work, test plans, protocols, and any other applicable documents
• Coordinate day-to-day team efforts by managing, mentoring and providing technical training to junior team members
• Prepare and present technical and organizational updates and forward-thinking proposals to Technical Operations leadership
• Lead technology transfer efforts to implement new processes and technologies in collaboration with Analytical Development, MSAT, Quality, Manufacturing, Alliance Management and Engineering
• Evaluate and recommend new technologies for benchmark testing with Cellares instruments
• Author and review technical documents, procedures, reports and presentations to ensure accuracy and quality.

Requirements

• Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-20 years of process development experience in the cell and gene therapy field
• Subject-matter expert in T-cell, HSC, B, or other immune cell therapy modality
• Extensive hands-on experience with commercial cell processing instruments (Miltenyi Prodigy, Lonza Cocoon, Xuri Wave)
• Familiarity with diverse cell editing and payload delivery technologies (LVV, RVV, LNP, CRISPR, TALENs, ZFNs, etc.) 
• Excellent verbal and written communication skills; Able to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiences
• Knowledge and understanding of cGMP regulations and ICH guidelines preferred
• Self-awareness, integrity, authenticity, enthusiasm and a growth mindset.