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.
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