Director of Manufacturing

Title:                              Director of Manufacturing

Department:                 Operations

Reports To:                  Vice President of Global Operations

Pay Classification:       Exempt

Position Summary:      Oversees and directs all manufacturing operations, including the quality of all goods produced.  Using process, quality and production improvement methodologies, the Director of Manufacturing directs the activity of Formulations, Production, and Assembly for new or existing products and technologies through a strong relationship and affiliation with Quality.  This individual will also lead, manage, and support the manufacturing groups responsible for product transfer activities from R&D to Operations, process improvements, validations, and investigations, in accordance with applicable regulatory requirements and guidelines.  Executes day to day activities to ensure attainment of operational goals, tactics, priorities, as well as identify resource needs. Management responsibilities also include developing and implementing policies and procedures, as well as coaching manufacturing staff, and driving business results.

Duties & Responsibilities include but are not limited to:

  • Direct the efforts and activities of all Manufacturing Staff, which includes Formulations, Production, and Assembly.  
  • Engages QA/QC staff to meet daily production requirements according to the manufacturing standards and GMP quality standards.
  • Develops and implements manufacturing capability and capacity, as well as maximizes production schedule to meet and optimize company strategic goals.
  • Facilitates decision-making, resolves conflict, and builds/optimizes cross-functional team efforts to assure that all manufacturing objectives are met.
  • Maintain an active role in facilities planning to optimize work flow.
  • Guide all employees by interpreting policies, goals, and purposes of the organization.
  • Optimize throughput and improve asset efficiency by utilizing engineering resources to increase yields and reduce losses/scrap. Work to improve first pass quality.
  • Fostering a continuous improvement culture through process excellence project management and lead continuous improvement initiatives
  • Continuously look for areas of manufacturing process improvement, which may include equipment, procedure or staffing changes.
  • Works actively on gross margin improvement through annually planned COGS reduction.
  • Maintains ongoing analysis of key issues, projects, and objectives, and provide regular reports that include metrics to summarize the status and trends of key operational parameters.
  • Provide a platform that encourages increases in productivity and improvements in quality, cost and service management by implementing department goals based on key performance indicators.
  • Under the direction of the Vice President of Global Operations, collaborate with Supply Chain, Procurement and Logistics Department to develop and deploy strategic manufacturing plans that includes manufacturing site capacity, technology, process capability/controls,
  • Collaborate with HR in the area of talent development that is aligned with operations objectives, quality objectives, product requirements, and business strategies.
  • Ensure proactive engagement and representation of Manufacturing during product development cycles to ensure future products meet quality, service, and cost objectives.
  • Work in close collaboration and partnership with Finance, Human Resources, Sales, Marketing, Materials, Manufacturing Engineering, Quality, & Regulatory departments to optimize overall operational excellence. Continually apply LEAN manufacturing principles to daily and tactical planning.
  • Provide guidance and leadership on root cause analysis investigations for non-conformances that are the direct result of manufacturing deviations.
  • Utilize talent management to source, attract, select, train, develop, retain, promote, and move employees through the organization in coordination with the company’s overall strategic plan.
  • Lead, manage, and coordinate manufacturing groups responsible for product transfer from R&D to Operations, process improvements, validations, and investigations, in accordance with applicable regulatory requirements and guidelines.
  • Collaborate with other departments to manage costs, as well as identify cost savings associated with Production Capacity, Manufacturing Efficiencies, and staffing, while assuring quality requirements.
  • Work effectively with R&D to support new product development activities and assure successful transfer of new products to Manufacturing/QA/QC.
  • Coordinate with other functions (Regulatory Affairs, Sales & Marketing, etc.) to identify customer requirements, and assure these are achieved prior to final release of finished product.

Qualifications Required:

  • Bachelors degree or higher in an engineering or science related field. MBA is a plus.
  • 6-10 years in progressive operations management experience including 3 – 5 years in the invitro diagnostics medical device industry.
  • Well organized in managing multiple projects and areas of responsibilities through the use of technology tools and managerial experience. Competent in prioritization and work content / resource estimating.
  • Experience with Microsoft Office applications and ERP systems. NetSuite functionality experience is a bonus.
  • Excellent skills in the management of direct, indirect and exempt staff.
  • Competent in inspiring team behavior as well as managing conflict de-escalation and problem resolution.
  • Experience in managing within a regulated QMS protocol.
  • Excellent verbal and written communications skills, as well as strong organizational leadership skills are required.
  • Knowledge of GMP’s, ISO, FDA, WHO and CE Mark guidelines related to industry.
  • Knowledge and experience related to automation, equipment qualification and validation in a regulated environment.
  • Familiar with OSHA compliance procedures and standards
  • Familiar with general accounting principles and practices, project management, and general HR practices.
  • Portrays a positive, can-do, problem solving, professional attitude at all times. Always compliant with Employee handbook.
  • Responsibilities include coverage for Managerial duties within a 24/7 work schedule when issues arise. Occasional weekend and evening work required.
  • Travel up to 10% of the time as required by the company.

For immediate consideration, please send a resume to
Chembio is an Equal Opportunity Employer.