Position Summary
We are seeking an innovative and highly motivated Supervising Principal 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, iPSC or other immune cell therapy modalities
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
Skills Required
- Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-20 years of process development experience in cell and gene therapy
- Subject-matter expert in T cell, HSC, iPSC or other immune cell therapy modalities
- Extensive hands-on experience with commercial cell processing instruments (Miltenyi Prodigy, Lonza Cocoon, Xuri Wave)
- Familiarity with cell editing and payload delivery technologies (LVV, RVV, LNP, CRISPR, TALENs, ZFNs)
- Experience leading technology transfer, developing test plans/protocols, program timelines, and performing gap assessments
- Experience managing, mentoring and providing technical training to junior team members
- Excellent verbal and written communication skills; able to present scientific results to technical and non-technical audiences
- Knowledge and understanding of cGMP regulations and ICH guidelines
- Self-awareness, integrity, authenticity, enthusiasm and a growth mindset
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
