Job Summary

Responsible for the overall management, direction and coordination of manufacturing personnel and processes. Areas of responsibility include but may not be limited to: formulation, component preparation, filling, visual inspection and packaging. This position coordinates the execution of manufacturing schedules against sales forecast and plant capacity. Collaboration with department managers and/or supervisors along with support groups is necessary. Responsible for manufacturing budget, compliance against applicable cGMP’s, regulatory requirements and company SOP’s and policies.

Salary Range: $142,929-$263,912 + 22% annual bonus & additional $25,000 award

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

• Establishes and controls the processes and procedures for compounding, component preparation, filling, visual inspection and packaging.
• 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.

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.
• Excellent analytical and technical skills.
• Excellent written and verbal communication skills.   Must be