Director, Quality Control

About the Company

At Editas Medicine, we are pioneering the possible. Our mission is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. We aim to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

We are a team of courageous problem solvers, harnessing CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed through collaboration, mutual respect, and innovation.

About the Role

The Quality team is seeking a highly motivated and experienced technical and organizational leader in gRNA, mRNA, and Lipid Nanoparticle (LNP) analytical methodologies and GMP testing. The successful candidate will collaborate with a high-performing CMC team, coordinating with process and analytical experts cross-functionally in Research and Discovery, Process Development, Analytical Sciences, Manufacturing, and Quality Assurance. This role involves transferring, qualifying, and overseeing in-process and release testing to advance Editas' in vivo gene medicine portfolio, as well as contributing to the overall program CMC strategy.

Responsibilities

• Lead phase-appropriate CMC analytical development, qualification/validation, transfer, and optimization through strong collaboration with key stakeholders and external partners.
• Drive the analytical control strategy for in vivo medicines toward IND/CTA and clinical manufacturing.
• Ensure seamless transition of analytics from Analytical Sciences into GMP manufacturing.
• Collaborate with QA to generate, review, and approve documentation, including SOPs, change controls, deviations, CAPAs, and OOS/OOT investigation reports.
• Act as the lead Subject Matter Expert for gRNA, mRNA, and drug delivery (e.g., LNP) control strategy.
• Establish phase-appropriate specifications based on sound scientific rationale for critical starting materials (e.g., pDNA), drug substance (e.g., gRNA and mRNA), excipients (e.g., lipids and targeting moieties), and drug product (e.g., LNP).
• Oversee the external GMP testing of critical starting materials, novel excipients, drug substance, and drug product for clinical use.
• Implement stability programs to establish retest dates/shelf life of critical starting materials, novel excipients, drug substance, and drug product for clinical use.
• Lead cross-functional projects/working teams, champion new ideas/business process improvements to advance the company's in vivo pipeline and technology platforms.
• Author and review regulatory submissions, technical reports, SOPs, and work instructions.
• Stay up to date with the latest industry trends and product knowledge.
• Work cross-functionally (e.g., with Research, Business Development, and Legal) to evaluate novel manufacturing technologies and new business partners.

Requirements

• Degree in Microbiology, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related discipline with 8+ (Ph.D.), 10+ (M.S.), or 12+ (B.S.) years of relevant experience in drug development.
• Strong technical expertise and hands-on experience with analytical test method optimization, validation, and transfers, as well as CTO/CMO management.
• In-depth expertise in critical raw material, drug substance, and drug product characterization methods and specifications.
• Ability to develop analytical control strategies that are phase-appropriate (i.e., phase 1 vs. phase 3 requirements) and grounded in principles of risk management.
• Ability to apply Quality-by-Design (QbD) principles to process development strategy planning and execution.
• Exceptional leadership and interpersonal skills, as well as excellent presentation and scientific/technical writing skills.
• Strong organizational skills and ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment.
• Experience leading cross-functional collaborations with internal departments and external CDMOs.
• Understanding of related industry guidelines (FDA, PDA, ICH, and BPOG), knowledge of FDA, EMA, and ICH regulations, and understanding of the product development life cycle.

Benefits

• Blue Cross Blue Shield PPO Medical Plan
• 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 Assistance Plan
• Wellness Programs
• Flexible Paid Time Off policy

Pay

Salary Range: $215,000 - $235,000. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered.