Sr Manager, Production

Fresenius Kabi USA•Melrose Park, IL

1d•$150,000 - $170,000

About The Position

The Sr Manager, Production is responsible for the overall management, direction, and coordination of day-to-day Aseptic and/or Isolator filling operations, production personnel, and processes. The role provides direction, cadence, and urgency to supporting functions, including commodity preparation, Formulation, and Lyophilization. Areas of responsibility include formulation, component preparation, aseptic filling, capping, and lyophilization. The position reports to the Sr Director, Manufacturing Operations. The role provides leadership across production operations and related support activities, ensures processes meet production objectives and regulatory requirements, and leads operational initiatives, change management, continuous improvement, and development of the manufacturing organization. It works closely with cross-functional teams and senior site and corporate leaders to support high-quality injectable pharmaceutical production.

Requirements

Bachelor’s degree or an equivalent combination of relevant education and experience.
At least eight years of manufacturing operations experience, including at least three years of progressively responsible leadership experience.
Ability to lead in a complex, fast-paced manufacturing environment, with 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.
Strong written, verbal, interpersonal, and executive communication skills.
Demonstrated experience implementing new production equipment, manufacturing processes, technologies, or production capabilities.

Nice To Haves

Degree in Engineering, Life Sciences, or a related technical discipline.
Experience within an FDA-regulated pharmaceutical manufacturing environment.
Experience in aseptic pharmaceutical manufacturing.

Responsibilities

Provide 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 with Validation, the Technology Center, Engineering, Quality, and other cross-functional teams to implement and qualify equipment, technologies, and manufacturing processes.
Establish short- and mid-term operational goals and work with supervisors and cross-functional partners to develop and implement processes and strategies for achieving business objectives.
Ensure manufacturing methods, processes, and operating practices support production objectives and comply with FDA requirements, applicable current Good Manufacturing Practices (cGMP), and site standard operating procedures.
Lead and participate in complex operational initiatives to strengthen manufacturing infrastructure, systems, processes, and regulatory compliance; guide the development of risk assessments, remediation plans, and sustainable corrective actions.
Operate independently and regularly engage with senior site leadership, corporate operations leaders, and external business partners.
Lead day-to-day functional activities and exercise appropriate departmental decision-making authority in internal and external meetings.
Lead and support change management through consistent processes, clear communication, leadership alignment, and employee engagement.
Collaborate across functions to identify and implement product and process improvements that enhance manufacturing performance, quality, reliability, and supportability.
Coach and develop the manufacturing organization to enhance technical capabilities, teamwork, accountability, and consistent production of high-quality injectable pharmaceutical products.
Provide technical leadership in troubleshooting equipment, process flow, manufacturing, and product-related issues.
Develop, monitor, and use key performance indicators to evaluate manufacturing performance and identify opportunities to improve product quality, deviation rates, scrap, labor utilization, regulatory compliance, throughput, and yield; reduce bottlenecks and work-in-process; and optimize resource allocation.
Lead quality and continuous improvement initiatives through effective documentation and review of manufacturing results, investigation outcomes, process changes, and improvement activities.
Ensure compliance with company requirements, programs, and procedures related to Health, Safety, Environment, Energy, and Quality Management Systems.