Job Summary
This position 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.
This position 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 that support the terminal sterilization lines including terminal sterilizers and aseptic fill lines including lyophilizers. Indirectly manages approximately 400 Direct Labor Production Employees and Manufacturing Engineers.
Responsibilities
POSITION RESPONSIBILITIES
- Establishes and controls 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 the manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
- Achieve optimum employee levels with the least amount of overhead and raw material costs to meet 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 department management/subordinate levels, as well as executive/Supervisor levels to inform personnel of communications, decisions, policies, and all matters that affect their performance and results.
- Hire, train, develop, and evaluate staff. Take corrective action as necessary on a timely basis and in accordance with company policy. Ensure compliance with current federal and local regulations. Consult with Human Resources Department as appropriate.
- Identify, recommend, and implement changes to improve productivity, reduce defects and reduce cost and scrap, monitor scrap and rework data. 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 the deviation writers to close deviations needed for on time batch release.
- Direct and coordinate various programs essential to manufacturing procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.)
- Initiate and coordinate major projects (e.g., plant layout changes, installation of capital equipment, major repairs, etc.)
- Work effectively and relate well with others. Exhibiting a professional manner in dealing with others while working to maintain 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.
- Perform miscellaneous duties and projects as assigned and required.
As part of Top Management, you have the overall responsibility and accountability for all aspects of the Health, Safety, Environment, Energy, and Quality Management Systems, including the following:
- taking overall responsibility and accountability for the prevention of work-related injuries and ill health, the protection of the environment, as well as the provision of safe, harmless, and healthy workplaces,
- ensuring that the Health, Safety, Environment, Energy, and Quality Management Systems' policies and related objectives are established and are compatible with the strategic direction of the organization
Salary Range: $190,000 - $225,000 * Position is eligible to participate in a bonus plan with a target of 16% of the base salary * 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. POSITION REQUIREMENTS
- Bachelors of Science degree in related field or equivalent education and experience.
- 10 years of experience in pharmaceutical manufacturing in a cGMP environment required with 5 years of progressive levels of managerial experience and broad span of organizational control.
- Terminal sterilization and lyophilization experience preferred.
- Excellent analytical and technical skills.
- Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment 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,401K with company contribution, andwellness 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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