Supply Chain Senior Analyst, Technical Operations – 1080 – Cambridge, MA

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.

• Coordinate shipments of in-process GMP materials and released clinical materials between vendors and storage sites
• Support business operations of CMC activities including managing submission business and technical agreements though internal approval process, and tracking project billing against SOWs and approved budget
• Support Monthly clinical and pipeline supply planning meeting
• Partner with Clinical Operations and cross-functional CMC Teams to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.
• Represent supply chain in cross-functional CMC Team Meetings
• Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues
• Review clinical trial protocols and understand impact on supply
• Support the clinical product label development process which includes creation of master label text, translations, and label proofs
• Track reconciliation of product returns and destruction
• Work with quality assurance to establish Editas cold chain and temperature sensitive product shipment risk management and shipping lane plans.
• Coordinate US and International distribution of clinical trial material
• Manage cold chain and other temperature sensitive shipments.
• Create a system to control and manage temperature sensitive shipments, site and shipment excursions.
• Maintain files for US Customs Compliance and proactively remit duties in a timely manner as required.

Requirement:
• B.S or B.A.; preferably to be in science, manufacturing or business management background.
• Approximately 5+ years in clinical and commercial supply chain management preferably with cell and gene therapy products
• Proven track record of supply chain planning, materials/inventory management, and business process facilitation, including:
o experience with supplying global clinical trials
o management of vendors for Cold Chain Storage, Packaging, Tracking and Distribution
o Experience importing and exporting human cell and gene therapy products for use in clinical trials
• In-depth knowledge of import and export requirements for countries in which ATMP products are distributed
• In-depth knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements
• Must be able to work independently on multiple projects and able to prioritize your own work with minimum supervision.

We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.