Associate Director, Analytical Development – 1145 – 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 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.

This role on the Analytical Development 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 lead a team of scientists to develop, qualify and transfer molecular and cellular methods for the characterization of gene editing components for cellular therapies, including ribonucleoprotein (RNP) complexes comprised of a specific CRISPR nuclease protein and corresponding guide RNA and adeno associated viruses.

Key Responsibilities:
• Lead cross functional team to develop analytics to support process development and manufacturing of CRISPR nuclease proteins, RNP complexes, and viral vectors to support gene-edited cell therapy programs at Editas
• Develop methods to support formulation development and work with Process Development team to generate and analyze data to determine optimal buffer formulations and storage conditions of individual CRISPR gene-editing components
• Develop understanding of most relevant Critical Quality Attributes of RNP complexes to guide safe and effective clinical testing and support gene editing of cellular products
• Interface with Editas colleagues in other departments to achieve successful clinical translation
• Author and/ or review documentation including standard operating procedures, development reports, electronic lab notebook reports, sample plans, data packets, certificates of testing, qualification protocols and reports
• Transfer analytics to external Contract Test Labs and QC labs at Contract Development and Manufacturing Organizations.
• Serve as a representative on CMC teams and author regulatory documents

Minimum Qualifications:
• Advanced life sciences degree and 10+ years of multi-disciplinary experience in the cell therapy/ gene therapy/ biotech/pharmaceutical industry with multiple years involved in development of biologics, including protein and viral based therapeutics
• Technical experience in development, qualification and transfer of molecular (droplet digital PCR, qPCR, next generation sequencing), immunological (ELISA), and cell-based assays
• Experience developing and managing 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
• 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

Preferred Qualifications:
• Experience developing, qualifying and transferring biophysical biophysical assays (HPLC/ UPLC, mass spectrometry, capillary electrophoresis)
• Familiarity with regulatory requirements applicable to ancillary process components and critical process materials
• Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for cGMP operations
• Experience developing, testing and commercializing biologics, nucleic acids, and cell therapy products, including preparation of documents for submission to regulatory agencies
• Understanding of product development life cycle and stage gates from research to development to commercial operations

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.