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Cellares

Posted 3 months ago

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Senior Scientist, Process Development (I,II,III)

South San Francisco, CAOn-siteFull-time

AI Summary

Senior scientist who designs and analyzes cell therapy process development experiments to advance a manufacturing platform, leading cross-functional transfer and training.

About this role

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.

    • Skills

    BioreactorCell Isolation/purificationCell Therapy Process DevelopmentCGMPData AnalysisDOEElectroporationHSC TherapyICH GuidelinesLNPLonza CocoonLVVMiltenyi ProdigyProtocol DevelopmentQA DocumentationRVVStatistical AnalysisT Cell TherapyTechnical WritingTech TransferTransductionTransfectionXuri Wave

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