David Junge
Scientist
Standish,ME
Summary
Skilled Technical Director with a Lean manufacturing mindset driving meaningful change with 30+ years in the regulated diagnostics industry. Responsible Scientist with strong technical base and creativity to handle changing needs. Accomplished in leading staff to ever-higher standards of quality and innovation in operations production. Team based problem solving skills working cross-functionally to improve and robust processes.
Overview
37
37
years of professional experience
1
1
Lean Practitioner
1
1
Six Sigma Training
Work History
Operations Manager- Bulk
Idexx
Westbrook, ME
06.2021 - 10.2023
- Drove transformational change of lower producing high turn-over group into employee led high functioning lean operations team.
- Led with candor and developed strong networks with internal customers and supporting groups.
- Team has completed over 115 kaizen projects beating our 2023 target of 75 kaizen projects by early October 2023.
- Mentored two people out of hourly positions to salaried positions.
- Grew and promoted every member of the team within two years.
- Directed technical operations staff in the development and implementation of new processes and procedures.
- Created and led cross functional Gemba meeting involving 7 inter-relational groups including logistics, quality control, fill, bulk and planning.
- Managed multi-process operations area for bulk solutions used as diluents, washes, controls, calibrators, intermediate compounds with over 800 documented processes. Process ranged from 10 mL to 800L.
Operations Manager
Idexx Laboratories
Westbrook, ME
09.2019 - 06.2021
- Prepared production schedule for Bioprocess operations with planning coordination
- Managed 4 to 6 direct reports.
- Hired and helped 5 employees grow and achieve promotions from hourly and salaried positions.
- Principle coaching leader who instills confidence, stability, and stretches employees leading with love and earning trust.
- Led team to complete transfer of new cell culture processes involving hybridoma cells and transient transfected mammalian cells.
Senior Sientist
IDEXX Laboratories
Westbrook, ME
09.2018 - 09.2019
- Mammalian cell culture stock maintenance and propagation of attached cell lines.
- Viral production of viral lysate in continuously infected and non-infected cell lines.
- Growth and production of Leishmania parasites in a biosafety level 2 production method.
- Separation, concentration, and processing to remove biohazard and allow further processing of parasitic lysate.
- Participated in improving safety of inclosed space involving liquid nitrogen storage of cells and viruses.
Senior Biochemist
Siemens Healthineers
Elkhart, IN
07.2011 - 09.2018
- Hybidoma cell line production
- Bioreactor development
- Bioreactor scale-up
- Cell Separation technology development
- Antibody concentration development
- Cell Banking
- Weaning cells to serum free medium
- Refinement and increased production yields
Senior Scientist- Process Development
Abbott Laboraties
Abbott Park, IL
04.2010 - 07.2011
- Process development of large-scale perfusion bioreactors
- Medium Scale Cell Filtration
- 15L scale production methods
- Roller bottle production development
- Serum-free cell line weaning
Scientist- Process Development
Abbott Laboratories Limited
Abbott Park, IL
03.1998 - 04.2010
- Generic process validation of hollow fiber cell culture process for CBER FDA regulated products.
- Troubleshooting for manufacturing processes.
- Development and process transfer to operations.
Associate Scientist
Abbott Laboratories Limited
Abbott Park, IL
06.1991 - 03.1997
- Developed and implemented cell culture process into operations.
- Production support for operations in viral, parasite, and antibody production.
- Wrote operating procedures for equipment and processes needed in operations.
- Performed analytical tests for viral antigens including RIAs, EIA's, and agglutination assays.
Prep Technician II
Abbott Laboratories Limited
Abbott Park, IL
02.1987 - 06.1991
- Production of HIV and HTLV-I viruses in a biosafety level 3 environment in cell culture.
- Purification of viruses and parasites by concentration and centrifugation.
- Growth of mammalian cells in suspension and adherent cells.
- Preparation of sterile vessels for use.
- Review of manufacturing documents for approval and release to MQA.
- Writing and getting approval for process deviations.
- Authoring and obtaining approval for changes to approved operations documents.
Education
Bacteriology
University of Wisconsin - Madison
Madison, WI12.1987
Skills
- Problem Resolution
- Production Updates
- USDA, FDA, and ISO Production
- Process Transfer
- New vendor qualifications
- Equipment IQ/OQ/PQ
- Documentation writing
- SAP operations user
- SAP PI sheet updates
- Mammalian cell culture
- Process development
- Operations focused
- Bioreactor process development
- Bioreactor scale-up
- Hybridoma process development
- Cell banking
- Cell separation techniques
- Parasite and virus production
- Lean manufacturing practitioner
- Unifier
- Workflow Optimization
- Performance Reporting
- Continuous Process Improvement
- Project Leadership
- Employee Motivation
- Staff Retention
- Multi-Site Operations
- Cross-Functional Collaboration
Timeline
Operations Manager- Bulk
Idexx
06.2021 - 10.2023
Operations Manager
Idexx Laboratories
09.2019 - 06.2021
Senior Sientist
IDEXX Laboratories
09.2018 - 09.2019
Senior Biochemist
Siemens Healthineers
07.2011 - 09.2018
Senior Scientist- Process Development
Abbott Laboraties
04.2010 - 07.2011
Scientist- Process Development
Abbott Laboratories Limited
03.1998 - 04.2010
Associate Scientist
Abbott Laboratories Limited
06.1991 - 03.1997
Prep Technician II
Abbott Laboratories Limited
02.1987 - 06.1991
Bacteriology
University of Wisconsin - Madison