Sr Manager, Production

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

Benefits offered by this job

401(k) with company contributions

Paid vacation, holidays and personal/s

Health, dental, vision insurance

Life insurance

Disability insurance

Employee assistance program

Job summary

The Sr Manager, Production at Fresenius Kabi USA leads day-to-day operations of aseptic and isolator filling, directing production personnel and processes including formulation, component preparation, aseptic filling, capping and lyophilization. The role reports to the Sr Director, Manufacturing Operations.

Salary range is $150,000–$170,000 with a target bonus of 14%. Benefits include a 401(k) plan with company contributions, paid vacation, holidays and personal days, health benefits to include

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Strong leadership and cross-functional collaboration skills.
• Experience in FDA-regulated pharmaceutical manufacturing environment is highly preferred.

Responsibilities

• Provide overall leadership for production scheduling, QC, manufacturing operations, QA, engineering, maintenance, equipment validation, training, non-conformance investigations, laboratory testing coordination, and product release activities.
• Collaborate with Validation, the Technology Center, Engineering, Quality, and other cross-functional teams to qualify new equipment, technologies, and processes.
• Establish short- and mid-term operational goals and develop effective processes to meet business objectives.
• Ensure manufacturing methods and practices comply with FDA requirements, cGMP, and site SOPs.
• Lead and support complex initiatives to strengthen manufacturing infrastructure and implement corrective actions.
• Interact with senior site leadership and external partners to drive decisions and improvements.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

Project management

Strategic planning

Mentoring

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Job description

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.

Salary Range: $150,000 - $170,000 based on experience

• Position is eligible to participate in a bonus plan with a target of 14% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Operate with a high degree of independence and regularly engage with senior site leadership, corporate operations leaders, and external business partners.
7. Provide leadership for day-to-day functional activities and exercise appropriate decision-making authority on behalf of the department in internal and external meetings.
8. Lead and support effective change management by leveraging consistent processes, clear communication, leadership alignment, and employee engagement to drive successful and sustainable implementation.
9. Collaborate across functions to identify and implement product and process improvements that enhance manufacturing performance, quality, reliability, and supportability.
10. Coach, develop, and strengthen the manufacturing organization to enhance technical capabilities, teamwork, accountability, and the consistent production of high-quality injectable pharmaceutical products.
11. Maintain a strong understanding of manufacturing operations and provide technical leadership in troubleshooting equipment, process flow, manufacturing, and product-related issues.
12. 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.
13. Provide active leadership in quality and continuous improvement initiatives through effective documentation and review of manufacturing results, investigation outcomes, process changes, and improvement activities.
14. 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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life.

Our U.S. headquarters is in Lake Zurich, Illinois and the company's global headquarters is in Bad Homburg, Germany.

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