
Director, Manufacturing Operations
Fresenius Kabi USA, LLC, Melrose Park, IL, United States
Job Summary
Director, Manufacturing Operations oversees management of all areas of Manufacturing operations to produce products and direct activities so that approved products are manufactured on-schedule within the quality standards and cost objectives.
Reports directly to the Plant Manager.
Directly manages approximately 7 Production Manager(s) and/or Senior Manager(s) for the formulation, filling, and component preparation departments supporting terminal sterilization lines.
Indirectly manages approximately 400 Direct Labor Production Employees and Manufacturing Engineers.
Position requires working onsite at our Melrose Park, IL site.
Position does not offer visa sponsorship now or in the future.
Salary Range: $190,000-225,000.
Eligible to participate in an annual bonus plan with a target of 16% of the base salary.
Eligible to participate in the medium‑term incentive plan.
Additional benefits include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and comprehensive health benefits (medical, prescription drug, dental and vision coverage).
Responsibilities
Establish and control the processes and procedures for compounding, aseptic and terminal sterilization filling, component preparation, capping, and lyophilization.
Assist company officers and senior staff members in the development and formulation of long‑ and short‑range planning, policies, programs, and objectives.
Develop manufacturing plans and establish procedures for maintaining high standards to ensure product conformance with customer and company quality standards.
Achieve optimum employee levels with the least amount of overhead and raw material costs to meet the annual budget.
Formulate and recommend manufacturing policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
Direct and monitor department managers and supervisors to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. Act as a liaison between management/subordinate levels and executive levels to inform personnel of communications, decisions, policies, and all matters that affect performance.
Hire, train, develop, and evaluate staff. Take corrective action as necessary in accordance with company policy. Ensure compliance with federal and local regulations. Consult with Human Resources as appropriate.
Identify, recommend, and implement changes to improve productivity, reduce defects and scrap, monitor scrap and rework data, and direct the establishment, implementation and maintenance of production standards.
Direct and coordinate efforts to improve Right First‑Time execution, reduce deviations, and manage the prioritization of deviation writers to close deviations needed for on‑time batch release.
Direct and coordinate various programs essential to manufacturing procedures (training, safety, housekeeping, cost reduction, worker involvement, security, etc.).
Initiate and coordinate major projects (plant layout changes, installation of capital equipment, major repairs, etc.).
Work effectively and relate well with others. Exhibit a professional manner while maintaining constructive working relationships.
Keep current on information and technology affecting functional areas to increase innovation and ensure compliance.
Participate in the preparation and presentation of site‑related business metrics and performance metrics, such as Line OEE achievement and production output, to upper‑level management.
Support regulatory inspections and company audits as the subject‑matter expert for the assigned departments under your control and engage direct reports as needed for support.
Job Requirements
Bachelor's of Science degree in a related field or equivalent education and experience.
10+ years of experience in pharmaceutical manufacturing in a cGMP environment with 5+ years of progressive managerial experience and broad organizational control.
Terminal sterilization and lyophilization experience preferred.
Excellent analytical and technical skills.
Excellent written and verbal communication skills; ability to communicate and interact with all levels of the organization and handle dynamic environments to meet plant and company objectives.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401(k) with company contribution, and wellness program.
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.
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Director, Manufacturing Operations oversees management of all areas of Manufacturing operations to produce products and direct activities so that approved products are manufactured on-schedule within the quality standards and cost objectives.
Reports directly to the Plant Manager.
Directly manages approximately 7 Production Manager(s) and/or Senior Manager(s) for the formulation, filling, and component preparation departments supporting terminal sterilization lines.
Indirectly manages approximately 400 Direct Labor Production Employees and Manufacturing Engineers.
Position requires working onsite at our Melrose Park, IL site.
Position does not offer visa sponsorship now or in the future.
Salary Range: $190,000-225,000.
Eligible to participate in an annual bonus plan with a target of 16% of the base salary.
Eligible to participate in the medium‑term incentive plan.
Additional benefits include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and comprehensive health benefits (medical, prescription drug, dental and vision coverage).
Responsibilities
Establish and control the processes and procedures for compounding, aseptic and terminal sterilization filling, component preparation, capping, and lyophilization.
Assist company officers and senior staff members in the development and formulation of long‑ and short‑range planning, policies, programs, and objectives.
Develop manufacturing plans and establish procedures for maintaining high standards to ensure product conformance with customer and company quality standards.
Achieve optimum employee levels with the least amount of overhead and raw material costs to meet the annual budget.
Formulate and recommend manufacturing policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
Direct and monitor department managers and supervisors to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. Act as a liaison between management/subordinate levels and executive levels to inform personnel of communications, decisions, policies, and all matters that affect performance.
Hire, train, develop, and evaluate staff. Take corrective action as necessary in accordance with company policy. Ensure compliance with federal and local regulations. Consult with Human Resources as appropriate.
Identify, recommend, and implement changes to improve productivity, reduce defects and scrap, monitor scrap and rework data, and direct the establishment, implementation and maintenance of production standards.
Direct and coordinate efforts to improve Right First‑Time execution, reduce deviations, and manage the prioritization of deviation writers to close deviations needed for on‑time batch release.
Direct and coordinate various programs essential to manufacturing procedures (training, safety, housekeeping, cost reduction, worker involvement, security, etc.).
Initiate and coordinate major projects (plant layout changes, installation of capital equipment, major repairs, etc.).
Work effectively and relate well with others. Exhibit a professional manner while maintaining constructive working relationships.
Keep current on information and technology affecting functional areas to increase innovation and ensure compliance.
Participate in the preparation and presentation of site‑related business metrics and performance metrics, such as Line OEE achievement and production output, to upper‑level management.
Support regulatory inspections and company audits as the subject‑matter expert for the assigned departments under your control and engage direct reports as needed for support.
Job Requirements
Bachelor's of Science degree in a related field or equivalent education and experience.
10+ years of experience in pharmaceutical manufacturing in a cGMP environment with 5+ years of progressive managerial experience and broad organizational control.
Terminal sterilization and lyophilization experience preferred.
Excellent analytical and technical skills.
Excellent written and verbal communication skills; ability to communicate and interact with all levels of the organization and handle dynamic environments to meet plant and company objectives.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401(k) with company contribution, and wellness program.
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.
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