Manager, Fill Finish Drug Product Manufacturing -Weekend Operations

This position is responsible for managing the day-to-day activities of fill & finish manufacturing. This position is responsible for implementation of all production and manufacturing equipment and procedures to optimize processes and regulatory requirements. The Manager coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment. The position's schedule will include weekend operations.

Responsibilities

Oversee daily operations including formulation, filtration, filling and troubleshooting any issues; Batch record review and generation; Strategic planning with DP manufacturing including defining schedule, coordinating preparation, and troubleshooting; Client calls, interactions and meetings; Internal investigations; Facility planning; Audit responses; Quality interactions; Direct and provide expert knowledge in day-to-day function of Drug Product Manufacturing; Coach, mentor, engage and develop the team; Maintain transparent communication

Requirements

Bachelor’s degree in scientific discipline or equivalent experience; Minimum of seven (7) years of related technical experience; Minimum of three (3) years of leadership/supervisory experience; Understanding of cGMP; Understanding of regulatory requirements; Solid command of chemistry including understanding of fillers and processes regarding filling; Understanding of QAD, Master Control, LIMS, and RAM

Benefits

Paid time off; Health insurance coverage including dental and vision; Flexible spending account; 401(k) plan; Annual performance bonus eligibility