Associate Director, Quality Control Operations - 2422
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.
Editas is seeking an experienced Quality Control leader for Editas’ cGMP manufacturing facilities. This is an important position that will refine and lead all aspects of GMP QC Operations of early and late-phase clinical development with future commercial approval in mind. This includes collaborating with internal and external strategic partners to manage testing and Certificate-of-Analysis generation (raw material, Drug Substance, and Drug Product), manage the Contamination Control Program (e.g., Environmental Monitoring, Aseptic Process Validation, etc.), and all compliance elements (e.g., deviation, CAPA, change control, etc.) related to GMP manufacturing.
Key Responsibilities & Accountabilities:
- Expected to embrace Editas’s core values of Engagement, Teamwork, Drive, Resilience, and Accountability.
- Management and leadership of high performing QC functions, including Microbiology, Analytical, and Molecular Biology operational teams based on a clear understanding of current and future business needs to ensure successful business delivery.
- Provide direct supervision to analysts including: scheduling, setting goals and objectives, training and ensuring development plans are in place. Interview and hire new candidates and complete performance reviews fairly and on-time.
- Reviewing executed QC test method results and reports for product release and disposition, including the investigation and resolution of deviations and observations
- Partners with Quality Compliance for inspection and audit readiness activities in coordination with Corporate Quality.
- Coach and develop direct reports to ensure the organization has a continuous improvement mindset, develops clear goals and metrics and delivers on the goals.
- Maintain accurate and current information on quality control capabilities, testing lead times, and capacity availability.
- Develop tools and business processes to increase efficiency and delivery.
- Work with the team to proactively identify risks (technical or schedule delays) and drive mitigation action to ensure on-time delivery of test results.
- Provide required oversight to ensure the department is equipped with functional, calibrated equipment and necessary supplies to meet business needs.
- Ensure systems and processes meet compliance needs and regulatory expectations.
- Develop training curricula and On The Job Training (OJT) requirements for QC staff.
- Assists Quality Management with budget and resourcing.
Knowledge, Skills & Capabilities:
- Experience with biologics is required, experience with cell and/or gene therapy products is preferred.
- Knowledge of microbiological, analytical, and molecular biology methods and technologies.
- Collaborative with partners to advance the Editas mission.
- Strong knowledge of global regulations and guidelines (EU, U.S., Japan).
- Previous experience with clinical and commercial manufacturing, specifically BLA/MAA filings and subsequent inspections and commercial launch requirements.
- 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.
Education & Relevant Work Experience:
- A minimum of a bachelor’s degree in microbiology or related discipline is required.
- A minimum of 12+ years of working experience in Biotech or pharmaceutical QC laboratory.
- A minimum of 5 years managing internal GMP QC lab operations.
Physical & Travel Requirements:
- On-site at the Waltham and the Devens Manufacturing facilities
- Ability to effectively work with remote and hybrid teams.
- Ability to routinely travel (~ 25%) to CMO facilities in North Carolina and Colorado.
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.