Senior Scientist, Cell Therapy Process Development

MaxCyte is a leading provider of cell-engineering platform technologies to advance innovative cell-based research, development, and commercialization of next-generation cell therapies. The company's existing customer base ranges from large biopharmaceutical companies — including 20 of the top 25 pharmaceutical companies based on 2020 global revenue — to hundreds of biotechnology companies and academic translational research centers. MaxCyte has granted 14 strategic platform licenses to commercial cell therapy developers that allow for more than 75 clinical programs. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, US.

Job Summary:

The Senior Scientist, Cell Therapy Process Development position plays a key role in implementing and optimizing processes related to the development of cellular therapies involving ex vivo engineering of primary immune cells and stem cells via flow electroporation. This individual will work independently to optimize cell isolation and culture protocols, develop assays, and integrate cell culture platforms and analytical technologies into a GMP-compliant workflow for non-viral cellular engineering. We are seeking a flexible self starter with the breadth of professional experience and drive to work effectively with both internal and external partners in a highly matrixed and cross- functional organization.

Job Responsibilities:

• Leads the establishment of a PD lab, including installation of equipment and the implementation of lab SOPs

• Supports cross-functional projects with biological scientists, mechanical/electrical engineers, and marketing/business development stakeholders

• Participates in internal and external collaborations to evaluate and implement new process technologies

• Improves non-viral cell engineering processes through designed experiments using innovative approaches

• Performs analytical assays to drive data collection for process development experiments

• Maintains up to date knowledge of cell therapy manufacturing trends and provides recommendations regarding manufacturing process improvement initiatives

• Develops, revises, and reviews SOPs, protocols, and process development and technical reports

• Complies with all applicable laws and Company policies regarding health, safety, and environment.

Job Requirements:

• PhD in immunology, cell biology, biochemistry, biology, bio or chemical engineering, or a related discipline with at least 5 years of hands-on experience in the cell therapy sector of the biopharmaceutical industry or a minimum of 10 years relevant experience with a master's degree.

• Excellent understanding of mammalian cell biology and metabolism

• Experience with cell processing techniques, cell culture methods for preparation of therapeutic cells, and cell separation technology, including product process optimization for multiple primary cell types (PBMCs, T cells, NK cells, stem cells, etc.)

• Experience with manufacturing scale processes using various cell culture platforms (e.g. Cell Factories, G-Rex's, Bioreactors, etc.) and equipment (CliniMACS, Sepax, LOVO etc.)

• Significant experience in engineered cell therapies with special emphasis on non-viral methods

• Thorough knowledge of cGMP manufacturing, process automation and technology transfer

• Extensive experience with analytical methods for cell and gene therapy, including in depth knowledge of flow cytometry and test methods, such as qRT-PCR and immunological assays

• Ability to independently conceive experimental designs, make detailed observations, analyze and interpret data, propose improvements to and troubleshoot experimental protocols

• Strong quantitative, qualitative, and critical thinking skills and abilities. Ability to adapt to changing needs as experiments develop or priorities change

• Detail oriented with strong organization and project management capabilities

• High energy level and a positive outlook coupled with the requisite “can do” attitude

• Strong written and oral communication skills are essential; ability to present thoughts clearly and concisely

• Ability to effectively collaborate with and lead vendors, customers, colleagues, and direct reports across teams. Ability to quickly adapt to a rapidly changing environment and demands

• Demonstrated computer skills; experience using MS Office and other data analysis software and other related applications.

MaxCyte, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter . Please reference Cell Therapy Process Development in the subject line.