Editas Medicine Senior Manager, External Manufacturing - 2432 in Cambridge, Massachusetts
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Key Responsibilities & Accountabilities:
Serve as externally-facing point of contact for select vendors and contract manufacturing organizations
Responsible for leading cross functional teams to drive facility start up activities for cell therapy manufacturing
Identify vendor ecosystems, develop and submit RFPs, perform site visits, and select vendors in accordance with program timeline and budget
Manage the review and implementation of contractual quality and legal agreements
Develop, socialize, and manage project plans, budgets, and timelines
Review and implement manufacturing and QC documents, and oversee tech transfer activities
Provide support for gene editing component manufacturing as needed
Knowledge, Skills & Capabilities:
Technical experience in the production of cell-based therapies
Experience with facility start up strongly desired
Strong project management experience and proven track-record of managing external project to completion
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
Understanding of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP and GTP operations
Strong team player that has a customer service approach and is solution oriented
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
Education & Relevant Work Experience:
- B.S. with 6+ years of multi-disciplinary experience in biotech/pharmaceutical industry with experience working with external partners and vendors
Physical & Travel Requirements: <15%
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.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.