Michael Duveneck Email & Phone Number

Franksville, Wi

Franksville, Wi

Development of chemical test methods and supervision of day-to-day laboratory activities. Writing of method validations and non-conformance investigations.

Management of all instruments for four departments and administration of laboratory software systems. Management: Schedule and plan instrument qualification for chemical quality, biological quality, and compendial affairs groupsDevelop and execute work streams for remediation and LEAN initiatives for laboratory instrument qualification and computer systems GMP processesInterim manager of Quality Systems group at Rocky Mount manufacturing siteMaintain annual capital expense budget for four departments by developing individual projects based on business needsAssist laboratory analysts in instrumentation trouble-shooting and provide technical support on execution of chemical test methods and use of laboratory instrumentsPerform investigations and impact assessments for failed calibration intervals and implement preventive actionsDesigned and implemented transfer plan that facilitated the movement and re-establishment of 17 active laboratories from the manufacturing plant to the corporate offices without interrupting their cycle timesWrite investigations for laboratory failures, method deviations, and validation non-conformitiesWrite CAPAs and effectiveness checks in support of activities at multiple manufacturing sitesWrite and implement audit responses and justifications Validation: Review and gap assess existing chemical method validations against pharmacopeias and ICH guidelinesIdentify chemical methods necessary for remediation or re-developmentInitiate and execute laboratory instrument qualification protocols and complete summary reports and initiate and complete validation investigations when applicablePublish operating procedures for validation activities, computers systems, and instrumentsReview and approve all validation protocols and documents for new instruments to be used at Rocky Mount location

Responsible for scheduling testing priorities and verifying laboratory data. Additional responsibilities included coordination of all calibration and validation activities for chemical test labs.

J.D., Law

Activities and Societies: Intellectual Property Law Review Editorial BoardFocus on Intellectual Property, Health Law, and Privacy Law..

Master'S Degree, Molecular Biology, Incomplete

Bs, Biochemistry