Contract Role: Supply Chain & CMC Operations Contractor

Role Summary:
We are seeking an experienced contractor to support the Technical Operations Supply Chain and CMC Operations team from approximately August 2025 through February 2026, with a possibility to extend based on company need and performance. The role will report to the Sr. Director of Supply Chain.

Key Responsibilities:
Supply Chain 
•    Maintain consistent and productive cross-functional collaboration with key partners: Clinical Operations/Study Teams, CMC functions, Quality, Regulatory, Program Management, CRO, etc.
•    Plan and deliver on-time, compliant clinical supply for assigned study(ies) 
•    Manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, oversight of packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management 
•    Responsible for oversight of scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations 
•    Support development of clinical and technical documents, including but not limited to: clinical label text, clinical/master batch record, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA 
•    Ensure product requirements and costs for the budget are complete and in place for assigned projects 
•    Other duties as assigned 

CMC Operations 
•    Manage projects to time, cost, and quality, and facilitate meetings/project communications (minutes, trackers, etc.). 
•    Act as Project Manager and point of contact for Contract Development and Manufacturing Organization(s) (CDMOs) 
•    Drive on-time starts for manufacturing, on-time completions for release, general readiness enabling 
•    Process inbound tasks from vendors utilizing existing standardized system for tracking, review, and approval. 
•    Facilitate clinical and non-clinical shipments, including scheduling and documentation and general inventory management 
•    Support communication to executive leadership and key stakeholders on TechOps progress, milestones achieved, and any deviations from the established execution plan. Update existing dashboard plans and issue status reports. 
•    Other duties as assigned 

Ideal Candidate:
•    Bachelor’s degree or advanced degree in scientific or engineering fields with 6-8 years of experience in clinical supply chain and logistics 
•    Strong experience managing clinical supply activities for global late stage randomized, I&I and/or IBD clinical trials 
•    Detailed knowledge of clinical packaging and labeling procedures 
•    Experience working with biologic CDMOs 
•    Working knowledge of import and export laws and processes 
•    Strong analytical and critical thinking skills 
•    Proficient in data analysis tools and software 
•    Detail-oriented, excellent communication skills, and the ability to work effectively in a fast-paced environment 
•    Experience in a small company or start-up environment is preferred 
 
What We Offer:
•    Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, and learn quickly.  
•    100% remote