Senior/Principal Research Associate, Cellular Process Development – 1097 – Cambridge, MA

Job Description

Location – Cambridge, MA

Editas Medicine is a transformative genome editing company with a mission to translate its genome editing technology into a novel class of human therapeutics that enable precise and corrective genome level molecular modification to treat the underlying cause of a broad range of diseases.

This new role on the Chemistry, Manufacturing, and Controls (CMC) team provides a unique opportunity to contribute to Editas’ efforts to develop safe and effective cellular therapies using CRISPR-based gene editing technologies. We are seeking a talented and highly-motivated individual to perform experiments that generate data to guide development of processing methods and standard operating procedures (SOPs) for the preparation of cellular therapies for translational clinical studies. This individual will develop and execute of isolation and cryopreservation procedures for various cell types (PBMCs, T cells, CD34+, etc.). Candidate must be experienced with aseptic technique and be versatile to assist in the development of processes for autologous or normal donor cellular products derived from different lineages of cells (T cells, HSCs, etc.).

Responsibilities:
•Perform experimentation to develop cellular processes to support gene-edited cell therapy programs at Editas
•Develop or improve isolation, cryopreservation, and post-thaw assessment methods for various cell types
•Performing post-thaw analysis on cells to confirm suitability for use in research and development
•Generate and maintain cell inventories
•Compile data, perform analysis, and generate technical reports to support developed cellular processes for clinical manufacturing
•Work with Analytical Development to generate and analyze data to develop understanding of most relevant critical quality attributes of cellular products to guide safe and effective clinical testing and process control strategies
•Collaborate with internal teams to ensure cells isolated and cryopreserved support ex vivo program research and development needs
•Assist with the technical transfer of cellular manufacturing methods to Manufacturing or external CMOs

Requirements:
•BS degree in life sciences with 5+ years of related industry experience or MS degree in life sciences with 2+ years of related industry experience
•Experience with aseptic technique and cell culture, preferably including isolating, culturing, and freezing cells using automated equipment and closed processes
•Experience with blood and cellular analytical methods including complete blood counts with differentials, cell counting, and multi-color flow cytometry
•Understanding of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP operations and experience with development or technical transfer of GMP manufacturing methods for cellular therapies preferred
•Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment
•Strong verbal and written communication skills
•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

We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.