Senior Specialist/Manager, Supply Chain - 2400
Editas Medicine, United States
Job Description
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.
Key Responsibilities amp; Accountabilities:
- Manage third-party logistics provider and track clinical shipments of patient material between apheresis center and manufacturing site (domestic amp; international shipments)
- Coordinate with Clinical, Manufacturing, and Quality teams for manufacturing scheduling, lot release, and shipment of Drug Product
- Oversee shipment of Drug Product to clinical sites
- Partner with Clinical Operations and cross-functional CMC Teams to identify demand assumptions, such as enrollment rate, number of sites, etc.
- Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues
- Work with quality assurance to establish Editas cold chain and temperature sensitive product shipment risk management and shipping lane plans.
- Manage cold chain and other temperature sensitive shipments
- Develop inventory models and forecasts for critical components, drug substance, and drug product to support manufacturing production planning
Requirements
Knowledge, Skills amp; Capabilities:
- Ability to oversee supply chain planning, materials/inventory management, and business process facilitation
- In-depth knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements
- Cold chain distribution experience
- Must be able to work independently on multiple projects and able to prioritize your own work with minimum supervision.
Education amp; Relevant Work Experience:
- B.S or B.A preferred
- 2-5 years experience in supply chain, logistics, or operations management
- Experience with autologous cell therapy logistics preferred
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.