Scientist II: Cellular Process Development
Editas Medicine, United States
Job Description
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Key Responsibilities amp; 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
Requirements
Knowledge, Skills amp; 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 amp; Relevant Work Experience:
- PhD in Chemical Engineering, Biomedical Engineering or related technical/scientific field with 2-5 years of process development experience