Associate Manager/Manager External Clinical Supplies

Overview

This position of Associate Manager/ Manager External Clinical Supplies will oversee on-going and new clinical trial supply planning, distribution of drug to clinical sites and budget management while adhering to Good Manufacturing Practices, company policies and procedures. This individual shall support the Contract Manufacturing Organization providing oversight of aseptic drug product manufacturing.

Responsibilities

• Support outsourced Phase 2 and 3 clinical trials, this includes but not limited to:
  • Phase 2 and 3 trials labeling and clinical Distribution, liaison with clinical team, Investigate and onboard new clinical service provider.
  • Support of any deviations/investigations/complaints resulting from Clinical trial shipments.
  • Review and approve invoices.
  • Manage Clinical Services Supply budget.
  • Monitor and revise product forecasts.
• Drug Product Contract Development Manufacturing Organization (CDMO) oversight, this includes but not limited to:
  • Support for person-in-plant (PIP) DP fills at both Catalent Bloomington and Vetter
  • Support of any deviations/investigations/complaints resulting from CDX-0159 DP production, testing, stability
  • Support of CDMO DP Process Characterization planning and activities and preparation and execution of Process Qualification batches for DP

Qualifications

• Interpersonal skills to effectively manage internal and external communications.
• Analyze inventory, forecasts and budget spreadsheets.
• Project management skills
• Proficient in the use MS Outlook, Word, Excel, PowerPoint, Project

Education/Experience:

• Bachelor’s or Master’s degree with 3+ years of experience in engineering or Biological Sciences.
• 3-5 years’ experience in managing Clinical Supplies, materials management planning or inventory management.
• Project Management Certification