Manufacturing Specialist - 2404
Location
Waltham, MA | United States
Job description
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:
- Full ownership of Manufacturing Deviations, CAPAs and Change Controls (including initiation, investigation, root cause analysis with cross functional groups and closure)
- Generate, revise, review and approve SOPs, batch records and other quality documents to support internal manufacturing projects and ensure all documents are maintained to accurately reflect the most current process
- Participate in inspection readiness and inspection support activities, performing data mining when required
- Recommend/implement process changes/improvements or safety/ergonomic improvements
- Operations readiness, (monitor material consumption, orders, transactions, material expiry and availability and assist with onboarding new inventory electronic system)
- Create, assign, perform, and maintain training for manufacturing staff while continuously tracking gap reports as required
- Support cleanroom operations including review and tracking of equipment records for PM/calibration and cleanroom maintenance and cleaning
Requirements
Knowledge, Skills & Capabilities:
- Must have experience with Cell Therapies
- Must have experience working in a GMP environment
- Must have technical knowledge to work as a liaison between MFG, Process Development, Quality Control and Quality Assurance
- Must have experience with GMP document creation/revision
- Must have experience with Excel and Microsoft Office applications
- Must have ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
- Must have experience with Quality Management Systems
- Must have ability to work flexible hours to complete work activities
- Must have ability to make decisions and work with minimal to moderate supervision
- Strong organizational skills and attention to detail with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment
- Excellent verbal and written communication skills
- Preferred experience with gene editing processes
Education & Relevant Work Experience:
- BS in Biology-related field of study with minimum 5-6 years of experience in a GMP environment
Physical & Travel Requirements:
- Must be willing and able to travel between Devens and Waltham locations
Benefits
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.
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.
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