Manager, Fill Finish Drug Product Manufacturing - Weekend Operations - 2nd Shift

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.

Responsibilities

Oversees daily operations including formulation, filtration, filling and troubleshooting any issues; Batch record review and generation; Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting; Client calls, interactions and meetings; Internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews); Facility planning (Shutdowns, maintenance, HEPA certifications, and media fill planning); Audit Responses (Client, QP, and Regulatory Inspections, SOP and Batch record revisions); Quality interactions (EM investigations, OOS investigations, Deviation Investigations); Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing; Identifies, recruits, and retains top-notch talent; Coaches, mentors, engages and develops the team; Sets performance standards and encourages employee engagement; Maintains transparent communication; Provides oversight and direction to employees

Requirements

Bachelor’s degree in scientific discipline or equivalent experience required; Minimum of seven (7) years of related technical experience; Minimum of three (3) year of leadership/supervisory experience; Understanding of cGMP's; 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

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