Clinical Supplies Manager

Job Title: Clinical Supplies Manager
Job Location: Paramus, NJ - (100% Onsite)
Duration: 3 months

Job Description:

• Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies.
• Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents.
• Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product.
• Assist and support the management of clinical supply inventories using Interactive Response Technology.
• Expected to prepare data tables when needed for data interpretation.
• Assist with documentation and process internal and external change controls.
• Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc.
• Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking.
• Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global).
• Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits.
• Assist and support Clinical Operations on document reviews related to the study specifics, such as pharmacy manual, study protocols, investigational brochures, etc.

Qualifications:

• Bachelor s degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background.
• Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports.
• Expert technical skills, good organization skills, ability to follow directions, and good communication skills.
• Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data.
• Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities.
• Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products.
• Knowledge of GMP batch record development, review, and approval process.
• Demonstrated understanding of the entire supply chain and associated cost drivers.
• Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system.
• Knowledge of Google Cloud Platform and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus.
• Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus.
• Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus.
• Ability to understand, maintain, and demonstrate troubleshooting on vendor s IRT/IVRS system, a plus.