Manager, HRAM

Position Overview

This position requires both supervisory and technical experience. Responsible for overall project leadership and serves as point of contact for client consultation and technical review of studies. Required to develop and validate new methodology and novel approaches to problem solving for analysis of constituents in testing matrices (including but not limited to, container closure systems, single use bio-process systems, drug products).

Responsible for method transfer in a coherent manner to subordinate chemists while adhering to appropriate regulatory requirements, including applicable SOPs, ICH Guidelines, US FDA, EMEA, US EPA Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).

• Responsible for overall supervision of HRAM group, and direct supervision of chemists to include training, career development and performing employee reviews.
• Responsible for overall project leadership of studies and collaboration across analytical groups.
• Accurately record and document raw data, observations and pharmacy usage.
• Ensure that work conforms to appropriate regulatory requirements, including SOPs, US FDA and US EPA Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).