Sr Manager, Production

Job Summary

The Sr Manager, Production is responsible for the overall management direction and coordination of the day-to-day operations of Aseptic and/or Isolator filling operations as well as the overall management, direction and coordination of production personnel and processes. This includes providing direction, cadence, and urgency to support function including commodity preparation, Formulation and Lyophilization teams. Areas of responsibility include but are not limited to; formulation, component preparation, aseptic filling, capping and lyophilization. It reports to the Sr Director, Manufacturing Operations.

Responsibilities

• Provide overall leadership and oversight for production scheduling, incoming quality control, manufacturing operations, quality assurance, engineering, maintenance, equipment validation, training, non-conformance investigations, laboratory testing coordination, and product release activities.
• Partner closely with Validation, the Technology Center, Engineering, Quality, and other cross-functional support teams to ensure the successful implementation and qualification of new equipment, technologies, and manufacturing processes.
• Establish short- and mid-term operational goals and work collaboratively with supervisors and cross-functional partners to develop and implement effective processes and strategies to achieve business objectives.
• Ensure manufacturing methods, processes, and operating practices support production objectives while maintaining compliance with FDA requirements, applicable current Good Manufacturing Practices (cGMP), and site standard operating procedures.
• Lead, manage, and participate in complex operational initiatives designed to strengthen manufacturing infrastructure, systems, processes, and regulatory compliance. Provide leadership and guidance in the development of risk assessments, remediation plans, and sustainable corrective actions.
• Operate with a high degree of independence and regularly engage with senior site leadership, corporate operations leaders, and external business partners.
• Provide leadership for day-to-day functional activities and exercise appropriate decision-making authority on behalf of the department in internal and external meetings.
• Lead and support effective change management by leveraging consistent processes, clear communication, leadership alignment, and employee engagement to drive successful and sustainable implementation.
• Collaborate across functions to identify and implement product and process improvements that enhance manufacturing performance, quality, reliability, and supportability.
• Coach, develop, and strengthen the manufacturing organization to enhance technical capabilities, teamwork, accountability, and the consistent production of high-quality injectable pharmaceutical products.
• Maintain a strong understanding of manufacturing operations and provide technical leadership in troubleshooting equipment, process flow, manufacturing, and product-related issues.
• Develop, monitor, and utilize key performance indicators to evaluate manufacturing performance and identify opportunities to improve product quality, deviation rates, scrap, labor utilization, regulatory compliance, throughput, and product yield, while reducing bottlenecks and work-in-process and optimizing resource allocation.
• Provide active leadership in quality and continuous improvement initiatives through effective documentation and review of manufacturing results, investigation outcomes, process changes, and improvement activities.
• Ensure compliance with all company requirements, programs, and procedures related to Health, Safety, Environment, Energy, and Quality Management Systems, consistent with the responsibilities and expectations of the position.

Job Requirements

• Bachelor’s degree required, or an equivalent combination of relevant education and experience. Degree in Engineering, Life Sciences, or a related technical discipline preferred.
• Minimum of eight years of manufacturing operations experience, including at least three years of progressively responsible leadership experience. Experience within an FDA-regulated pharmaceutical manufacturing environment strongly preferred.
• Demonstrated ability to lead in a complex, fast-paced manufacturing environment requiring strong leadership, technical aptitude, sound judgment, influence, and cross-functional collaboration.
• Strong project and change leadership capabilities, including experience leading complex operational or technical initiatives.
• Experience in aseptic pharmaceutical manufacturing strongly preferred.
• Strong written, verbal, interpersonal, and executive communication skills.
• Demonstrated experience implementing new production equipment, manufacturing processes, technologies, or production capabilities.