Industrial Site Leader - API

Overview

We are seeking a forward-thinking and dynamic Industrial Site Leader to join our team and oversee the production of active pharmaceutical ingredients (API). The ideal candidate will have a strong background in CMC, quality management, supply chain, and lean manufacturing, as well as a deep understanding of regulatory requirements in the API industry. They will report into the COO and focus on operational excellence.

Responsibilities

• Provide strategic leadership and direction for the API manufacturing site, ensuring operational excellence and efficiency.
• Oversee all aspects of production, including resource management, process improvement, and compliance with regulatory standards.
• Collaborate closely with cross-functional teams to drive continuous improvement in manufacturing processes and supply chain management.
• Implement lean manufacturing principles to optimize production processes and minimize waste.
• Foster a culture of safety, quality, and innovation within the manufacturing site.
• Develop and maintain strong relationships with regulatory authorities and ensure compliance with all relevant regulations and guidelines.

Qualifications

• Bachelor's or Master's degree in a relevant scientific or engineering discipline.
• Extensive experience in API manufacturing, with a proven track record of leadership and operational excellence.
• In-depth knowledge of CMC, quality management, and supply chain principles in a pharmaceutical manufacturing setting.
• Strong understanding of regulatory requirements for API production, including FDA and other relevant authorities.
• Demonstrated expertise in implementing lean manufacturing principles to drive process improvement and efficiency.
• Excellent communication, interpersonal, and leadership skills.

Day-to-day

• Collaborate with cross-functional teams to prioritize and execute production schedules.
• Analyze production data to identify opportunities for process optimization and efficiency improvements.
• Champion a culture of continuous improvement and operational excellence within the API manufacturing site.
• Engage with regulatory authorities to ensure compliance with all quality and safety regulations.
• Lead and mentor a diverse team of manufacturing professionals to drive performance and achievement of operational goals.

LI-On-site