Director, External Cell Product Manufacturing, Technical Operations – 1141 – Cambridge, MA

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 trans-formative, 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.

Editas Medicine is looking for a highly motivated and detail oriented individual to join our growing Technical Operations team.

Responsibilities:

Lead external manufacturing operations for Editas’ Cell Therapy Programs
Oversee the implementation and ongoing support of compliant cGMP manufacturing processes at Cell manufacturing sites
Work with CMC teams, Program teams and Supply Chain to determine optimal supply strategy
Participate in cross-function CMC teams
Manage and support tech transfer of process from Process Development to external CMOs
Participate on site selection and audit teams
Work with Quality Product Quality Lead to ensure a compliant and best in class operations
Contribute to investigations and batch release reviews to production schedule timelines.
Responsible for the development of effective and efficient working relationships with both internal and external partners.
Communicate operational status regularly to senior management and program teams, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.

Requirements

• Advanced degree and 15+ years of multi-disciplinary experience in the cell therapy/biotech/pharmaceutical industry with multiple years working in Cell and Gene Therapy manufacturing
• 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.
• Experience leading cross functional and/or operational teams, developing and commercializing cell/gene therapy products
• Advanced 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 desirable
• 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.
• 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

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.