What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. Weâre 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.
Weâre 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.
We seek an exceptional, senior level executive to lead and further develop our CMC capabilities as a strategic advantage for our company.
Reporting to the CEO, the SVP of Operations will be responsible for building the capabilities to produce our novel gene and cell therapy products. The SVP will lead Technical Operations, Global Supply Chain, Process Development, Analytics Development and Quality Control and Quality Assurance. S/he will be a recognized external leader in industry, will understand the international regulatory framework, external network of CDMOs, and will develop and own vision, strategy and tactics with the ability articulate these to the Executive Team and the Board of Directors.
Key Responsibilities
- Develop and execute a compelling strategic and operational plan blending internal and external resources to build capabilities into a strategic advantage for the company.
- Lead manufacturing of input materials, drug substance, and drug product to support pre-clinical Analytical and Process development. clinical trials from Ph1 through commercial launch. Ensure appropriate commercial readiness at CDMOs including coordinating high quality documentation to meet global regulatory expectations.
- Ensure that the manufacture of drug product is performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
- Establish the regulatory CMC strategy for commercialization with the Head of Regulatory Affairs.
- Regularly communicate the Editas scientific and business strategy and progress externally at scientific and business conferences and events.
- Provide inspiring and engaging departmental and company leadership in a fast paced, time-line driven environment.
- Develop future leaders within the company.
Requirements
Advanced degree of an appropriate scientific discipline. MBA is a plus
Find one job in US 