Overview

Summary of Position:

• Assist and support Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Analytical Chemistry Method Development and Clinical Trial Material (CTM) manufacturing.
• Review master batch records (MBR), Master Packaging Work Orders (MPWO), and protocols and reports of the following: Analytical Method Development, Analytical Method Validation, and Stability Studies.
• 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.
• Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking.

Responsibilities

Qualifications

• Bachelor’s degree in Chemistry (preferred analytical) and up to 5-8 years experience working in an analytical laboratory background
• Bachelor’s in chemistry (preferred analytical) degree up to 5-8 year’s 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 GCP 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
• Ability to multitask
• Adapts to change
• Maintains composure under pressure
• Ability to follow verbal and/or written instructions
• Use of effective verbal communications
• Grasps information quickly
• Examines and observes details
• Ability to work in a multi-cultural environment