Senior Scientist, Process Development (I,II,III)
PharmaBiotechQuality Assurancegmpcroinform
Job description
Position Summary Cellares is seeking an innovative and highly motivated Senior Scientist with expertise in cell therapy manufacturing to join the Process Development team. This individual will interface across many parts of the company and contribute significantly to the development of our advanced cell therapy manufacturing platform. The primary focus of this position is to design, coordinate, execute and analyze cell therapy process development experiments that expand and drive continuous improvement of the Cellares platform. The ideal candidate will be a highly organized technical leader and cross-functional collaborator with demonstrated expertise in developing robust autologous and allogeneic cell therapy processes. Candidates should also enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. Responsibilities
Design and execute complex experiments using scientific principles and statistical approaches (DOE) to support the development of the Cellares platform
Interface internally and cross-functionally with Analytical Development, MSAT, Quality, Manufacturing, BD, Product, and Engineering to implement new processes and technologies as part of the core technology transfer team
Author and review technical documents, procedures and reports to ensure accuracy and quality
Present technical and programmatic information to internal and client-facing stakeholders
Coordinate day-to-day team efforts and provide technical training and guidance to junior team members
Develop training materials for scientific methods and techniques, train and onboard new hires
Serve as subject matter expert where appropriate for the cell and gene therapy process, provide technical insights and support in troubleshooting and root cause investigations Requirements
Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-21 years of process development experience in the cell and gene therapy field
Subject-matter expert in T cell, HSC, or other immune cell therapy modality
Extensive hands-on experience with commercial cell processing instruments (Miltenyi Prodigy, Lonza Cocoon, Xuri Wave) relevant to cell selection/purification and expansion
Familiarity with diverse cell editing technologies (LVV, RVV, LNP) and processes (transduction, transfection, electroporation, 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, and a growth mindset.
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