Senior Process Engineer

Key Responsibilities & Accountabilities: Support the development of closed and automated clinical scale manufacturing processes for gene-edited cell therapy programs at Editas Provide supervision, training and guidance to direct report(s) Author and review process-related documentation (SOPs, batch records, study protocols, technical reports) to support development and GMP manufacturing Design and execute studies to evaluate, optimize and troubleshoot systems and processes for cell processing Compile, analyze, and present process data at functional team meetings Document all experimental work in the electronic lab notebook (ELN) in a timely manner Work with Analytical Development team to generate data to develop understanding of most relevant critical quality attributes of cellular products to guide safe and effective clinical testing Draft change controls, deviations, CAPAs, support root cause analysis and OOS investigations as needed Support technology transfer of cellular manufacturing process to internal manufacturing team as well as external CDMO partners RequirementsKnowledge, Skills & Capabilities: Experience developing and commercializing cell therapy products Experience with automated cell processing systems and closed processes Strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors Demonstrated technical proficiency, scientific creativity Good organizational skills with the ability to multi-task and prioritize assignments Strong team player who has excellent verbal and written communication skills Experience with technology transfer or process validation is a plus Education & Relevant Work Experience: PhD in Chemical Engineering, Biomedical Engineering or related technical/scientific field with 2-5 years of process development experience; or Master's with 8+ years process development experience.

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