Director - Drug Substance Manufacturing - Cook Pharmica - Bloomington

Job description
Primary Function
To provide leadership and direction in the planning and operation of the cell banking, cell culture, harvest, purification, and bulk fill functions in the API (Active Pharmaceutical Ingredient) manufacturing facility.

Essential Job Functions/Duties
• Direct and oversee the activities of manufacturing functions in the API business
• Oversee safety and general working conditions for manufacturing
• Ensure compliance with relevant company and regulatory direction and guidance
• Ensure compliance with all applicable company, federal and local safety and environmental regulations, guidelines and policies
• Identify resources needed for effective and efficient operations
• Ensure effective use of material, equipment and personnel resources
• Ensure consistent product quality through the establishment of appropriate manufacturing systems and controls

• Direct and guide departmental personnel in accordance with company philosophies by way of performance reviews, training and development programs, setting goals and objectives and promoting fiscal responsibility
• Provide manufacturing and business updates to management
• Participate in external and internal audit reviews
• Interact regularly with clients and current project teams

Desired Skills and Experience
Minimum Work Experience/Educational Requirements
• Bachelors degree in Science or Engineering or related fields or equivalent experience
• Minimum of 5 years supervisory experience
• Minimum of 10 years pharmaceutical experience with direct experience in the area of API manufacturing
• Required to sign a confidentiality and a non-compete agreement
• Extensive knowledge of manufacturing processes including regulatory and quality requirements
• Ability to analyze and solve complex problems using both standard problem solving and process improvement tools
• Proven experience in process analysis and improvement in a production / manufacturing environment
• Strong ability to set and meet goals/timelines

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