Director, Technical Services

The role

The Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling and finishing services. The Technical Services Director is a member of the plant senior leadership team and is responsible for the development, coordination and execution of clinical and commercial technical transfer and validation operations for syringe and vial filling/packaging activities. This includes providing guidance and technical expertise to multiple disciplines and serving as the technical liaison between the customer and manufacturing. The Director is also responsible for the strategic planning of the department. This position reports to the Site Director.

Responsibilities

• Lead cross-functional teams in technical transfer, commercial product support, sterility assurance validation, process validation, risk management, cleaning validation, inspection/packaging validation, and computer systems validation for filling and packaging operations
• Establish and deploy validation strategies in compliance with global regulatory requirements
• Direct the development and implementation of new processes requiring new technologies
• Understand and integrate information from more than one discipline and apply to complex problems requiring innovative techniques
• Budget development (>$10MM) and maintenance to meet business needs
• Responsible for final approval on product/process documentation, including CAPAs, deviation investigations and change controls
• Responsible for strategic planning, deployment, execution and after-action reviews
• Represent the site during regulatory inspections, client visits, and internal audits
• Collaborate with site Quality to drive improvements and risk reduction

Requirements

• Bachelor’s Degree in technical discipline required, preferably in science or engineering
• Minimum 10 years of experience in aseptic manufacturing operations required
• Minimum 8 years of technical management experience including cross-functional teams, resource and budget management and strategic development experience
• Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA, etc.)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use quality enterprise software systems

Physical / Safety Requirements

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Ability to meet Grade C gowning requirements
• Global travel may be required (10%)