What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. Were 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.
Were 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.
This new role on the Editas Manufacturing team provides a unique opportunity to contribute to the clinical translation of CRISPR technology by managing efforts that support the development and operationalization of Editas clinical programs.Responsibilities:
Lead internal CMC (Chemistry, Manufacturing, and Controls) team supporting the development and operationalization of Editas Cell Therapy program. Ensure compliance with cGMPs for the manufacture of pre-clinical and clinical materials.
Advanced degree or equivalent and 10+ years of multi-disciplinary experience in the cell therapy/biotech/pharmaceutical industry with 3 years of management/supervisory experience and multiple years leading and being part of cross functional teams
• Exceptional organizational skills with the ability to multi-task and prioritize assignments, strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines.
• Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP and GTP operations.
• Understanding of product development life cycle and stage gates from development to commercial operations
• Experience with custom media development, production, and CE marking
• Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
• Strong team player that has a customer service approach and is solution oriented
• 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