Senior Scientist, Cell Processing
Job Description
Actively looking for a Senior Scientist, Cell Therapy Process Development contributing to the development of early and late stage clinical cell therapy manufacturing processes. This position is responsible for development and technology transfer of internal and client related projects. The successful candidate will contribute to the design, execution, and analysis of development studies in the lab employing modern bioprocess methodologies such as Design of Experiment and Quality by Design. This position will actively interact with internal MFG/AD/QC/QA team and external client SMEs to develop and drive the strategy to support the successful delivery of client projects. The ideal candidate for this position should have work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH guidelines.
• Develop and optimize cell therapy manufacturing processes from scratch or using existing processes.
• Apply Quality by Design (QbD) methodology and Design of Experiments (DoE) approach in development to maximize capacity and reduce cost of goods. Assist in defining Target Product Profile (TPP), identifying Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).
• Lead and assist in technology transfer, GAP analysis, process industrialization of client projects
• Identify, assess, and implement new technologies to improve product quality, success rate, reproducibility and/or reduce cost and time of manufacturing processes.
• Act as the accountable point of contact from the process development for product/process support for technology transfers and ongoing cGMP drug product manufacturing.
• Responsible for trouble shooting, deviation investigation and product impact assessment for projects employing developed technology/processes.
• Coordinate with AD/QC team in analytical method development and characterization of products that are currently in development.
• Organize and prioritize work to meet timelines and ability to execute on multiple projects. Support client facing activities for the cell therapy process development team.
• Support Business and Project Management team for technical discussion with prospects/clients.
• Provide appropriate documentation and support clients in authoring CMC sections.
• Demonstrate strong oral and written communication skills. Author protocols, reports, risk assessments, SOPs, and batch records.
• Supervise, train and mentor junior staff to create a high performing team.
• Occasional domestic or international travel will be required.
Education or Equivalent Requirements:
• BS with 8+ years, MS with 6+ years or Ph.D. and 4+ years of experience in a biotechnology, cell therapy industry.
Knowledge/Skills Requirements:
• Deep understanding and experience of cell therapy process development is a must.
• Expertise in bioprocess development, QbD and DoE methodology
• Knowledge in various cell therapy/culture technologies
• Experience with common equipment used in cell therapy manufacturing such as Sepax, Lovo, G-Rex, Xuri Bioreactors, CliniMACs Plus, CliniMACS Prodigy, MaxCyte GT.
• Experience with nucleic acid/viral vector transduction/transfection is preferred.
• Hands-on experience with flow, PCR and cell-based assays is a plus.
• Good organizational and problem-solving skills, and attention to detail.
• Experience in GMP and Aseptic processing is preferred.
• Communicates clearly and concisely with diverse audiences, in both oral and written contexts, and is comfortable giving and receiving feedback.
