Position Description and Responsibilities:

• Manage the technical and laboratory staff in the development and qualification of reagent chemistry and assays.
• Plan, manage and deliver critical development projects as a core team leader
• Manage development transfer activities between R&D and operations
• Establish and maintain relationships to key suppliers and manufacturers
• Develop R&D infrastructure by assuring processes, tools, capital equipment, and lab facilities are effective and compliant
• Establish and maintain FDA compliant processes and documentation, including manufacturing and design control
• Manage the analytical test lab to support manufacturing and QC activities for lot screening, calibration and release, as well as for raw and intermediate materials testing.
• Lead process optimization efforts to increase efficiency of chemistry and lab testing processes to support scaled manufacturing.
• Contribute ideas to the Intuity patent portfolio by submitting patent disclosures and reviewing patent disclosures

Position Qualifications:

• Experience leading large complex projects utilizing several scientific and engineering disciplines
• Experience in design manufacture
• Excellent verbal and written communication skills and the ability to develop employees and effective cross functional relationships
• Experience in working in regulated product and manufacturing environments
• Experience designing and setting up automated lab processes (desired, but not required)
• Experience with blood glucose testing (desired, but not required)

Minimum Education:

• Minimum of a BS in a related chemistry science discipline (analytical, biochemical, synthetic etc.); MS or Ph.D degree preferred

Minimum Experience:

• 10+ years experience in all phases of product development to launch for high volume medical devices
• 7+ years in management and supervision of engineering teams or engineering departments

Working Conditions:

Some travel required <10%

Supervision:

Supervision of laboratory personnel supporting manufacturing of reagent chemistries and production lots

Supervised by:

Head of Manufacturing and Product Development