Director of Manufacturing

Department: Manufacturing
Reports to: Executive Director of Operations

The Director of Manufacturing is responsible for commercial manufacturing operations for drug and device products.  Serves as a key member of the management team responsible for strategic assessment of manufacturing capabilities and required upgrades to meet corporate objectives.  Ensures the effective use of facilities, equipment and personnel in producing quality products meeting customer delivery requests and internal performance targets.  The Director has P&L responsibility for all assigned functional areas.

Strategic Focus Areas

  • Provide leadership and direction for all Manufacturing personnel to foster a culture of operational excellence
  • Optimize resources within assigned areas to maintain compliance standards and cost discipline
  • Lead cross functional projects and activities which support the growth of the company

Specific Tactical Responsibilities

  • Implement processes and practices to achieve best in class performance in meeting production and customer delivery targets for Anika products
  • Perform strategic assessment of production processes and manufacturing capabilities to support long term growth objectives. Develop and implement plans to execute on volume, product transfer, and product development initiatives
  • Develop comprehensive measurements of performance within areas of responsibility to demonstrate and maintain best practice benchmarks
  • Foster a culture of continuous improvement, through employee selection, training and mentoring, that is focused on operational efficiency and eliminating waste
  • Collaborate with Marketing, Engineering and R&D to achieve successful transfer of new products to manufacturing; implement plans to meet new product launch delivery requirements
  • Analyze, develop and implement initiatives and improvements to reduce cost and improve efficiency of manufactured products
  • Lead multidiscipline project teams to timely and successful conclusion with new product launches, facility renovations, major process upgrades, and other projects as assigned
  • Develop and manage department operating budgets to approved targets; analyzes variances and take corrective actions
  • Advises senior management on production issues and vulnerabilities. Develop proposals for improvement and risk mitigation
  • Ensure processes and activities are compliant with FDA current good manufacturing practices, relevant international regulations as well as OSHA and EPA requirements
  • Interface directly with customers and regulatory personnel during plant audits and inspections
  • Oversee validation of facilities, equipment and processes to ensure continued state of compliance. Schedule and manage routine revalidation activities and change control
  • Responsible for the hiring, development and coaching of employees to ensure the proper level of performance of all manufacturing personnel
  • Other duties and projects as assigned

Job Complexity

The Director of Manufacturing has the primary responsibility for manufacture and delivery of product meeting internal and external customer expectations.  The job entails assessment of data and strong analytical decision making, superior leadership, interpersonal, organizational and team-building skills.  Erroneous or mistimed decisions may cause critical delays or cost impact and may have an immediate effect on the company’s success.

Supervisory Responsibilities

Responsible for first line supervision of Production supervisors for the manufacturing and packaging of aseptic and terminally sterilized commercial products

Required Qualifications

  • Bachelor’s degree in a Science of Engineering discipline or relevant experience
  • Minimum of 10 years of experience in an aseptic environment manufacturing cGMP pharmaceutical or medical device manufacturing with progressive experience leading to a management position
  • Candidate should have a thorough knowledge of applied pharmaceutical and/or medical device GMPs in a commercial manufacturing operation
  • Experience conducting complex root cause investigations, executing CAPA plans and managing change notices that require Regulatory assessment
  • A demonstrated record of excellent interpersonal skills as evidenced by working effectively with Quality Systems, Marketing/Sales, Finance, Engineering and R&D
  • Ability to develop and present technical and financial results to senior level management

Desired Experience, Knowledge, and Skills

  • A demonstrated record of working effectively with Quality Systems, Finance, Engineering and R&D
  • Thorough understanding of operational and standard cost accounting around financial aspects of manufacturing
  • Subject matter expert in aseptic production and regulations that govern aseptic manufacturing
  • Strong computer skills required to perform data analysis, reporting and project planning and tracking
  • Excellent verbal and written communication skills
  • Ability to work autonomously, effectively manage time and deliver results on time

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We are an Equal Employment Opportunity Employer