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
- 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 of a BS in a related chemistry science discipline (analytical, biochemical, synthetic etc.); MS or Ph.D degree preferred
- 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
Some travel required <10%
Supervision of laboratory personnel supporting manufacturing of reagent chemistries and production lots
Head of Manufacturing and Product Development