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. This position will be supporting 2nd shift. Schedule will include weekend operations.

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, including overseeing new employee onboarding and providing career development; Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management; Maintains transparent communication; Provides oversight and direction to employees in accordance with PCI Pharma Services policies and procedures

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 cGMPs; 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; Eligibility for annual performance bonus