Senior Aseptic Production Leader

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation

Holiday and personal days

Health benefits: medical, dental, and视

Vision coverage

Employee assistance program

Wellness program

Job summary

Fresenius Kabi USA in Melrose Park, IL seeks a Sr Manager, Production to lead aseptic and isolator filling operations and oversee formulation, lyophilization, and related production activities. The role reports to the Sr Director, Manufacturing Operations.

Salary ranges from $150,000 to $170,000 based on experience, with a target bonus of 14% of base salary and a comprehensive benefits package including 401(k) contributions, vacation, sick days, medical, dental, vision, and wellness programs.

Qualifications

• 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. 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.

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, Technology Center, Engineering, Quality, and other cross-functional support teams to ensure successful implementation and qualification of new equipment, technologies, and manufacturing processes.
• Establish short- and mid-term operational goals and work 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, cGMP, and site SOPs.
• Lead and participate in complex operational initiatives to strengthen manufacturing infrastructure, systems, processes, and regulatory compliance; develop risk assessments and remediation plans.
• Operate with independence and engage with senior site leadership, corporate operations, and external partners.
• Provide leadership for day-to-day functional activities and decision-making in internal/external meetings.
• Lead and support effective change management through consistent processes, communication, and leadership alignment.
• Collaborate across functions to identify and implement product and process improvements for performance, quality, reliability, and supportability.
• Coach and develop the manufacturing organization to enhance technical capabilities and accountability for high-quality injectable products.
• Maintain strong understanding of manufacturing operations and provide technical leadership in troubleshooting issues.
• Develop and monitor KPIs to evaluate manufacturing performance and identify opportunities to improve quality, deviations, scrap, labor utilization, compliance, throughput, and yield.

Skills

Leadership

Cross-functional collaboration

Project management

Change leadership

Executive communication

Education

Bachelor’s degree in Engineering/Life Sciences

Job description

Fresenius Kabi USA in Melrose Park, IL seeks a Sr Manager, Production to lead aseptic and isolator filling operations and oversee formulation, lyophilization, and related production activities. The role reports to the Sr Director, Manufacturing Operations.

Salary ranges from $150,000 to $170,000 based on experience, with a target bonus of 14% of base salary and a comprehensive benefits package including 401(k) contributions, vacation, sick days, medical, dental, vision, and wellness programs.