Director, Analytical Sciences

At Editas Medicine, we are pioneering the possible. Our mission and commitment 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.  Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.  

Why Choose Editas?

At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!

Decoding The Role:

The Director, Analytical Sciences will lead a team to develop and implement the analytical control strategies for Editas’s in-vivo programs.  Primary responsibilities include establishing bioanalytical test methods to characterize and control drug substances, drug products and novel excipients. The individual in this role is also responsible for establishing product specifications and shelf life; authoring and reviewing CMC sections of regulatory filings; managing reference material and critical reagents; leading/documenting complex laboratory investigations in the appropriate Quality systems (deviations/CAPA and Change Controls). The position requires a strong knowledge of cGMP/ICH/FDA/EMA regulations and regional pharmacopeia.       

This position will operate in a highly matrixed environment from Editas’s Cambridge, MA headquarters. The ideal candidate must have excellent communication skills and be able to effectively partner with internal and external partners/stakeholders.

Characterizing Your Impact:

As the Director, Analytical Sciences, you will:

• Embrace Editas’s core values of Engagement, Teamwork, Drive, Resilience, and Accountability.
• Develop and implement analytics to understand and control attributes through product characterization.
• Collaborate with external contract organizations to develop and implement analytics to support clinical cGMP manufacturing (in-process, release and stability testing).
• Manage phase appropriate method qualifications and method transfers.
• Work with the team to proactively identify risks and drive mitigation actions to ensure on-time delivery of test results.
• Work cross-functionally to troubleshoot and solve complex problems using relevant tools (e.g. root cause analysis and risk assessment).
• Work with QA to generate, review and approve Quality documentation, including: SOPs, change controls, deviations, CAPAs and OOS/OOT investigation reports.
• Author, review and approve CMC sections of regulatory filings.
• Manage stability programs and establish self-life for clinical drug substances, drug products and novel excipients.
• Manage reference materials (qualification and inventory) and critical reagents.
• Chair the Specification Review Board to set scientifically sound and phase appropriate specifications.
• Assist management with departmental budget and resourcing

Requirements

• A minimum of a bachelor’s degree in biology, chemistry or a related discipline is required.
• 10-15+ years of working experience in Biotech/analytical development laboratories.
• Experience working in a GMP environment is a plus.
• Significant experience with spectroscopic and chromatographic methodologies (LC-MS).
• Experience with molecular techniques (electrophoresis/PCR/Sequencing).
• Experience with cell-based potency and immunoassays.
• Knowledge of CRISPR/Cas9 gene editing technologies using LNP delivery.
• Experience with analytical method qualification/validation.
• Experience with regulatory requirements and able to bridge development and GMP expectations.
• Strong knowledge of global regulations and guidelines (EU, U.S., Japan).
• Experience working in a fast-paced and matrixed environment. 
• Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.

Benefits

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