The Principal Scientist will work with cross functional teams and assist with analytical method development, validation, release and stability specification assays, and additional assays needed to support cell and gene therapy client programs for Center for Breakthrough Medicines. This role requires someone with good knowledge of analytical development and scientific understanding of cell therapy products.
· Assist with technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell and gene therapy programs.
· Advance scientific understanding of cell therapy products.
· Assist with the application of state-of-the-art cellular analytics research techniques that aim to deepen product understanding in order to improve methods with respect to efficient and rapid method transfer/qualification execution.
· Provide scientific and technical assistance for analytical ultracentrifugation, molecular, virology and cellular analytical capabilities.
· Support CMC and product development teams to ensure robust data analysis, solid GMP method implementation, and broad incorporation of analytical strategy within CMC functions.
· Monitors project plans and resources to ensure alignment with overall research goals and objectives.
· Participate in and assist with various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, Testing, Process Development, Clinical and Commercial Manufacturing, and Quality teams.
· Provide scientific assistance with development operations, and clinical and commercial QC teams.
· Maintain current awareness of GMP/GTP and other regulations, industry standards and trends that are applicable to current and future Cell and Gene Therapy Development operations and products.
· Responsible for some administrative duties for the group.
· Independently applies scientific and/or cross-functional knowledge to achieve project goals.
· Implements strategic departmental research and development goals or ideas.
· Accountable for accomplishing project goals and objectives; anticipates and prioritizes workflow to achieve desired outcomes.
· Assist in implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards.
· Application of advanced scientific knowledge associated with larger and more complex experiments and projects.
· Defining and implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards.
· PhD plus 6-7 years of experience or MS in a relevant discipline (cell biology, Immunology, molecular Biology) with minimum of 16 years of relevant R&D/analytical development experience.
· Previous industry experience in allogenic and/or autologous cell therapy CMC or product development experience preferred.
· Established track record of success supporting early and late stage CMC and clinical product development teams. Cell therapy product characterization, method bridging, comparability, control strategy experience is a plus.
· Technical experience in analytical ultra-centrifugation, molecular biology, virology and/or cell-based potency methodologies
· Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management.
· Strategic thinker with excellent problem solving and conflict resolution skills.
· Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
· Strong troubleshooting and communication skills, highly organized with strong record keeping and an ability to multi-task.
· Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment.