Clinical Supply Chain Associate

Liquidia•,

About The Position

The Clinical Supply Chain Associate will support clinical drug supply activities related to planning, label development, packaging and labeling documentation, and distribution documentation for one or more clinical programs. Supports Clinical Supply Team to ensure supply plans are accurate and enable continuous supply to patients around the globe while reducing risk and minimizing waste. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment.

Requirements

BS degree in life science or technical discipline.
At least 3+ years experience in Clinical Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
Familiarity with clinical trials and supply chain processes is required.
Computer skills including Microsoft Office Suite products and working knowledge of various operational software systems including IRT software.
Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
Excellent project management and communication skills, with particular emphasis on negotiating and problem solving.

Nice To Haves

A degree in Supply Chain Management or certification is preferred.
Basic understanding of global regulations for investigational medicinal products is a plus.
Experience or coursework related to logistics, inventory management, or pharmaceutical materials is desirable.

Responsibilities

Assist the Clinical Supply Chain Team in supporting Clinical Study Teams (CST) and providing service to internal stakeholders (e.g., Clinical Operations, Regulatory, Quality, CMC).
Review and approve CMOs clinical packaging, labeling and distribution documentation.
Support the creation and maintenance of supply and inventory plans for clinical trial materials.
Monitor production schedules and inventory under supervision, report discrepancies or issues to the Team.
Assist in managing GMP inventory, preparing inventory reports, and tracking drug accountability.
Support relationships and daily activities with label & pack CMOs and distribution vendors as directed.
Help investigate exceptions and support implementation of corrective actions under guidance.
Assist in ensuring label text and proofs meet applicable rules, regulations, and study protocols.
Coordinate review and approval of labels with stakeholders and CMOs as assigned.
Support IRT user acceptance testing and ongoing supply activities in the system.
Help coordinate and track shipments to CMOs, depots, and vendors; assist with import license tracking.
Contribute to supply strategies to maximize efficiency and minimize waste, under supervision.
Participate in cross-functional projects and process improvements related to drug supply as assigned.
Assist in the creation of Standard Operating Procedures.
Support change controls for Clinical Supply Chain as directed.
All other duties as assigned.