We are partnered with an outstanding CDMO who have recently invested over a quarter of a billion dollars into their facility. They are looking to bring on a Director of Production Operations. They are currently building out their pipeline and are adding two new production lines to their massive facility. The Director of Production Operations will need to have great management experience and a history of consistently meeting deadlines where all are held accountable.
Responsibilities:
- Lead and manage the Production Operations team, including supervisors, technicians, and support staff, ensuring high performance, engagement, and adherence to safety and quality standards.
- Mentor and develop staff, promoting continuous improvement in skills, knowledge, and leadership capabilities.
- Collaborate with cross-functional teams (Quality, Engineering, Supply Chain, and Regulatory Affairs) to align production goals and timelines with client expectations and regulatory requirements.
- Oversee the sterile injectable production process, ensuring efficient and compliant operations in an aseptic manufacturing environment.
- Manage production schedules, ensuring on-time delivery while meeting or exceeding client requirements and regulatory guidelines.
- Ensure adherence to Good Manufacturing Practices (GMP), maintaining a sterile, controlled environment for the production of injectable products.
- Lead the implementation of process improvements, operational efficiency, and cost reduction initiatives within production.
- Ensure all operations comply with applicable regulatory standards, including FDA, EMA, and other international regulatory agencies for sterile injectable production.
- Drive adherence to Environmental Monitoring, Sterility Assurance, and other critical control measures in the aseptic manufacturing process.
- Lead investigations and root cause analyses for any deviations, non-conformances, or quality issues related to production.
- Collaborate with senior leadership to develop and implement strategic plans for production capacity, technology investments, and facility optimization.
- Manage resource allocation, including staffing, equipment, and materials to meet production targets while maintaining cost-effectiveness and compliance.
- Contribute to the development and execution of business strategies for scaling and enhancing production capabilities for sterile injectable products.
- Ensure a culture of continuous improvement through Lean and Six Sigma methodologies to drive quality and process optimization.
- Partner with the Quality Assurance department to maintain a high standard of documentation, quality control, and audit readiness.
- Lead and support CAPAs (Corrective and Preventive Actions), Change Control, and other continuous improvement initiatives.
- Serve as the primary operational point of contact for clients, ensuring production schedules, quality standards, and project milestones are met.
- Provide regular updates and reporting to senior leadership and external clients on production progress, challenges, and resolutions.
- Build strong relationships with customers, ensuring a high level of satisfaction and responsiveness to production needs.
Experience:
- Minimum of 10 years of experience in pharmaceutical manufacturing, with at least 5 years in a senior operations leadership role in a CDMO or similar environment.
- Extensive experience in sterile injectable manufacturing, aseptic processes, and cleanroom operations.
- Proven track record in managing production in a cGMP-compliant environment.
- Experience with regulatory agencies (FDA, EMA) inspections and audits.
- Strong understanding of sterile filling, lyophilization, and aseptic technique.
