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This position is a leader for one or more key segments of the PET (Process Execution Team) Operations.
In this capacity, the Director oversees and leads the PET Operations Segment(s) to ensure high quality product in accordance with the PET operating strategy. As a responsible leader for the PET, this must be done while inspiring team engagement, facilitating a collaborative work environment and ensuring compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards. This specific role is to lead building 3 startup and ongoing operations, including the establishment of all necessary processes.

Job Responsibilities

• Provide direction to PET leadership and employees in the efficient use of equipment and materials to produce quality products in accordance with PET Planning
• Lead support teams responsible for batch scheduling and process improvement projects
• Promote safe work practices during all aspects of production and ensures all external and Resilience EHS standards are consistently held at high bar
• Ensure effective training of PET employees on equipment, processes and Standard Operating Procedures is met. Partner with PET leadership to develop training plans and provide resources for training
• Drive compliance of cGMP during production of products to meet all FDA and international regulations. Respond to internal audit observations
• Promote a positive work environment through active communication and listening to inform team members and respond to their concerns, recognizing and celebrating high performance, quickly managing poor performance, and enabling learning and career development
• Ensure proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, and production logs
• Proactively monitor across org for functional area deviations, provide direction in investigations, and recommend/implement solutions to resolve deviations. Approve deviation investigations as appropriate. Respond to product defect notifications
• Author, review, and approve Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies
• Promote and encourage continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators
• Collaborate with PET Engineers, as applicable, to optimize process performance
• Participate in the design, selection, installation, and qualification of new equipment, facilities, and processes
• Consult, review, approve, and implement change control
• Co-own life cycle management of PET/facility assets

Minimum Requirements

• Significant experience in GMP or regulated production environment evidencing increasing managerial and production expertise
• Deep knowledge of FDA cGMPs
• Strong two-way communication and team leadership skills, including the ability to manage and participate in cross-functional teams
• Agile troubleshooting and problem-solving skills

Preferred Requirements

• Bachelor’s degree in administration, business, engineering, pharmacy, or a related science