Associate Director, Protein Process Development - 2409

Editas Medicine

Editas Medicine

Cambridge, MA, USA
Posted on Wednesday, September 13, 2023

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.

The In Vivo and Gene Editing Components Process Development team in the Process and Analytical Development (PAD) Department is seeking a highly motivated and experienced technical and organizational leader in protein product development from IND-enabling to commercial stages. The successful candidate will lead a high-performing team, coordinating with process and analytical experts within PAD and cross-functionally in Discovery, Supply Chain, Manufacturing, and Quality, to shape and steer upstream process development strategies to advance Editas’ gene medicine portfolio. The individual will also be a key contributor to overall program CMC strategies. This role requires strong technical expertise in late-stage protein manufacturing process development and characterization, as well as a passion to lead, mentor and influence people.

Key Responsibilities

  • Lead a team to define the strategy and drive the execution of late-stage upstream process development/optimization, scale-down model qualification (SDMQ) and process characterization for protein products (e.g., CRIPSR nucleases) as critical gene editing components
  • Lead a team to be responsible for upstream process scale-up and technical transfer to external manufacturing facilities for clinical and commercial manufacturing, in collaboration with Analytical, Manufacturing and Quality teams
  • Provide technical support for upstream clinical and commercial manufacturing and process validation for protein products as part of a CMC team and act as Subject Matter Expert (SME) for protein process science to lead the continuous improvement of the protein manufacturing process through well-coordinated internal and external development efforts
  • Responsible for production of representative protein materials for analytical method development and IND-enabling studies
  • Contribute to overall protein process characterization (both up- and downstream) and comparability strategies, study design and data interpretation
  • Perform a wide range of managerial duties including on-the-job training, career development, and appraising performance. Identify opportunities and provide the means for employees to pursue career growth.
  • Lead cross-functional projects/working teams, champion new ideas/business process improvements to advance company’s gene medicine pipeline and technology platforms
  • Support or lead CMC strategy development, implementation, and refinement for pertinent programs through strong collaboration with key stakeholders and external partners
  • Author and review of regulatory submissions, technical reports, SOPs and work instructions
  • Maintain abreast latest industry trends for bioprocessing and protein product knowledge, work cross-functionally (e.g., with Discovery, Business Development and Legal) to evaluate novel manufacturing technologies and new business partners Other duties as assigned

Education & Relevant Work Experience:

  • Degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 8+ (Ph.D.), 10+ (M.S.), 12+ (B.S.) years of relevant experience in drug development

Physical & Travel Requirements:

  • Travel to support technical transfer efforts, as required.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.