Clinical Supply Chain Associate

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.
• Aid 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.
• Investigate exceptions and support implementation of corrective actions under guidance.
• Aid 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.
• 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.
• Support the creation of Standard Operating Procedures.
• Aid in the creation of change controls for Clinical Supply Chain as directed.

Requirements

• BS degree in life science or technical discipline. A degree in Supply Chain Management or certification is preferred.
• 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.
• 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.
• Knowledge, Skills, and Competencies: Strong management and organizational skills and detail orientation with an ability to prioritize, enable, and accelerate multiple programs and projects while simultaneously delivering against the activities of daily operations. Ability to thrive in a multidisciplinary team environment is essential for success, with a strong ability to build relationships. Proven agility and success in a dynamic company / business environment where change is frequent and rapid understanding and alignment is paramount. 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.

Benefits

• A competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!
• Liquidia is an equal opportunity employer.