Sr Manager, Production (Formulation)

Fresenius Kabi USA•Grand Island, NY

3d•$119,149 - $166,645•Onsite

About The Position

Responsible for the overall management, direction, and coordination of the Grand Island formulation suites and the surrounding controlled environmental area associated with the formulation of liquid parenterals. Ensures adequate systems, equipment and resources are in place to meet production schedules, and that products are manufactured to specification and in complete accordance with applicable SOP’s, DEA, OSHA and cGMP’s regulations. This position directly manages at least 5 direct supervisors accountable for overseeing the formulating liquid products against delivered production schedules and compliance regulations on their respective shifts. Coordinating and overseeing staff development, hiring, disciplinary processes, and direction to complete assigned activities are required. The Sr. Manager, Formulation, through the supervisors, ensures the safe and quality focused work environment while accepting accountability for all activities within this position’s control. Managing Investigation work, as well as corrective and preventative measures when necessary is also required. The Sr. Manager is also responsible for ensuring adequate systems and equipment is in place to manufacture, clean, and store product. This also includes all new products and processes planned for the future.

Requirements

BS/BA in Science related discipline or equivalent.
8 years of pharmaceutical experience, minimum 3 years of managerial experience.
Working knowledge of SOP’s and cGMP’s rules and regulations
Demonstrated history of progressive leadership.
Proficiency in Microsoft Office required.

Responsibilities

Manages all area SOPs are reviewed/revised to encompass any changes in procedure and/or two-year review.
Manages the adequate resources are available to clean and prepare equipment.
Directs the shift Supervisors to ensure all area personnel are current in their training requirements; Ensures a safe work environment and that all personnel work in a safe manner.
Works closely with HR on policy changes, interpretation, and execution, hiring of new employees, employee disciplinary action, performance appraisals and performance management.
Leads the Technical Services/Maintenance to reduce downtime and improve equipment reliability; Assists with design of new systems/facilities related to the department.
Leads the Material Management and Quality regarding component/raw material problems and inventory maintenance.
Champion continuous improvement efforts to improve efficiency and cost competitiveness of the department.
Works closely with Environmental, Maintenance, Metrology, and Validation to ensure area environmental monitoring, PM, calibration, and re-qualification schedules are met.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.