Michael Knef
Colonia,NJ
Overview
6
6
years of professional experience
1
1
Certification
Work History
Development Scientist
Roche Molecular Diagnostics
08.2020 - 10.2023
- Development of chromatographic techniques, chemistries and other purification methods for the separation of DNA oligonucleotide primers and probes for use in commercial PCR Assays and Assay Development
- Subsequent scale-up from R&D and pilots lots to commercial batches while assisting validation and regulatory departments until product launch
- Development and drafting of associated SOP’s, Batch Records, and Best Practices for newly developed processes and products while maintaining adherence to GMP/GLP/GDP and other regulatory standards
- Troubleshooting and analysis of nonconformance's and deviations within already existing processes, products and documentation including redlining faulty documents or those requiring updates
- Interfacing with multiple departments including regulatory to ensure on time product launch
- Introduced new Tangential Flow Filtration equipment and optimized procedures allowing for the reduction of downstream processes by a factor of 2-3x while simultaneously increasing product recovery and reducing human errors and equipment failure.
Senior Laboratory Technician
Roche Molecular Diagnostics
07.2017 - 08.2020
- Operation and maintenance of multiple HPLC systems utilizing Unicorn operating system software (Affinity, IE, Ion Pair etc.)
- Maintained accurate quantitation of laboratory samples via UV-Vis and Fluorescence Spectroscopy methods
- Execution of batch records and processes while maintaining adherence to GMP/GLP/GDP processes
- Maintained vigilance of equipment status and process yield over time using LIMS/ Trackwise/ SAP software
- Reporting and handling of aberrant results, CAPAs, Deviations, OOS OOT investigations
- Change management for process changes and variances.
Education
Bachelor of Science - Biochemistry
Ramapo College of New Jersey
Skills
- Various HPLC Techniques
- UV/ Fluorescence Spectroscopy
- Microsoft Suite, Excel and Word
- Change Control
- Tangential Flow Filtration Techniques
- Presentation of Data and Findings
- Maintenance of Lab Equipment
- Tech Transfers
Languages
English
Native/ Bilingual
Spanish
Professional
Accomplishments
- Eagle Scout, Boy Scouts of America
- Henry Erlich Award for Scientific Innovation Runner Up, Roche Molecular Diagnostics
Certification
- HPLC For Practicing Scientists 1: Fundamentals and Pharmaceutical Applications (ACS ProED)
- HPLC For Practicing Scientists 2: Method Development, HPLC Operation, Troubleshooting and Biopharmaceutical Applications (ACS ProEd)
References
References available upon request.
Timeline
Development Scientist
Roche Molecular Diagnostics
08.2020 - 10.2023
Senior Laboratory Technician
Roche Molecular Diagnostics
07.2017 - 08.2020
Bachelor of Science - Biochemistry
Ramapo College of New Jersey
- HPLC For Practicing Scientists 1: Fundamentals and Pharmaceutical Applications (ACS ProED)
- HPLC For Practicing Scientists 2: Method Development, HPLC Operation, Troubleshooting and Biopharmaceutical Applications (ACS ProEd)
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