Michael Lennartz Email & Phone Number

Lafayette, In, Us

Indianapolis, Indiana, United States

• Designed cGMP (21 CFR Part 211, 212 and ICH) laboratories for RLT.• Authored and reviewed SOPs for new technologies. • Edited existing procedures to meet regulatory standards.• Assisted on establishing training curriculum for QC labs.• Liaised with groups globally to set up IT infrastructure.• Procured instruments for laboratories within budget.• Established protocols for instrument qualification (OQ/IQ/PQ) and periodic maintenance (PM)• Evaluated new chromatographic methods• Advised MS&T on radio-labeling and radiochemistry• Site subject matter expert (SME) on chromatography systems and chromatography data systems (Waters UPLCs and Waters Empower software)• Interviewed potential lab employees to establish QC team• Implemented electronic data systems (EDS) such as LabX, Empower, LIMS systems to help with data integrity (ie “paperless lab”)• Completed Radiation Safety Officer training. Acted as HSE expert on radiochemical handling for QC lab.

West Lafayette, Indiana, United States

-Develops/validates UPLC methods for radio-ligand therapeutics (RLT), small molecular drug conjugates (SMDC), intermediates, and starting materials.-Radio Pharmaceutical development work (RLT). -Radiolabeling of compounds developed by Discovery Research group.-Work with senior radiochemist to optimize radio-labeling procedures. -Analytical Method Development to support process chemistry. -Method improvement of UV, GC, and UPLC methods. -Technical writing including SOPs, analytical methods, stability protocols, method validation reports. -Analysis of stability samples and implementation of stability studies. -Oven Karl Fischer analysis.-ID analysis by LC/MS-Raw Material ID by FT-IR with ATR. -Analysis of toxicology and clinical trial samples.-Coordinates purchase/installation of new equipment; including FTIR with ATR, UV/Vis, GC with PAL, and Ion Chromatography systems-Liaison with third party vendor to improve Citrix Network-Coordinated Empower (Waters Chromatography Data System) upgrades on-site-Ion Chromatography-Project management with third party organizations and contract manufacturers and laboratories-Worked on Radio-Labeling procedures for Targeted RLTs (radioligand therapies) in development-worked with Radioactive isotopes: Lutetium, Indium, Gallium, Copper-Ran RadioHPLC on RLTs in development-Consulted on the design of new MS&T laboratory for new Targeted RLT production facility built by Novartis-Acted as Resource in use of MasterControl (document system)-Provided Metrology Support including working on contracts for yearly maintenance, working with third party vendors for Periodic Maintenance (PM) and qualifications, and assisting with on site instrument maintenance issues-Trained in Radio Chemical handling. Collaborated on writing updated Radio Safety SOPs

West Lafayette, In

-Analytical Method Development to support process chemistry. -Development/validation of UPLC methods for radio-ligand therapeutics (RLT), small molecular drug conjugates (SMDC), intermediates, and starting materials.-Method improvement of UV, GC, and UPLC methods. -Technical writing including SOPs, analytical methods, stability protocols, method validation reports. -Analysis of stability samples and implementation of stability studies. -Oven Karl Fischer analysis.-ID analysis by LC/MS-Raw Material ID by FT-IR with ATR. -Analysis of toxicology and clinical trial samples.-Coordinate installation of new equipment; including IR with ATR and GC with PAL system-Liaison with third party vendor to improve Citrix Network-Coordinated Empower (Waters Chromatography Data System) upgrades on-site-Ion Chromatography-Project management with third party organizations and contract manufacturers and laboratories-Worked on Radio-Labeling procedures for Targeted RLTs (radioligand therapies) in development-worked with Radioactive isotopes: Lutetium, Indium, Gallium, Copper-Ran RadioHPLC on RLTs in development-Consulted on the design of new MS&T laboratory for new Targeted RLT production facility built by Novartis

West Lafayette, In

-Method Development to support process chemistry. -Development/validation of UPLC methods for small molecular drug conjugates (SMDC), intermediates, and starting materials.-Method improvement of UV, GC, and UPLC methods. -Technical writing including SOPs, analytical methods, stability protocols, method validation reports. -Analysis of stability samples and implementation of stability studies. -Oven Karl Fischer analysis.-ID analysis by LC/MS-Raw Material ID by FT-IR with ATR. -Analysis of toxicology and clinical trial samples.-Coordinate installation of new equipment; including IR with ATR and GC with PAL system-Liaison with third party vendor to improve Citrix Network-Coordinated Empower (Waters Chromatography Data System) upgrades on-site-Ion Chromatography-Designed new laboratory spaces when upgrading facilities.

Lafayette, Indiana, United States

Supports the Bulk Pharma and Fermented Products areas of Tippecanoe Labs. Analyzes In-process, raw material, intermediate API, and Final API samples. * Performs Analytical Analysis using HPLC, GC and Wet Chemistry (UV, pH, IR, KF, Titrations, etc) Techniques,* Possesses excellent attention to detail. Verifies (2PV) other Analysts work. Reviews laboratory notebooks for data documentation errors. * Coordinates with chemists to perform method validations, method improvements projects, method transfers and homogeneity investigations. Assays R&D and investigational samples. Assists in reviewing revised or new analytical methods. * Functions as a technical resource for GC/LC and computer systems (GCDS/Empower/Smartlab). * Assists in training and mentoring in GC/LC, AHLC, and Empower. * Troubleshoots assays in GC and HPLC area. * Empower "Power User." Part of TL921 Empower team that addresses Empower issues. Investigates Empower issues in lab. Reviews Empower methods before lab implementation. * Has strong multitasking skills. Provides the ability to work in multiple areas while second person verifying and mentoring. * Assists supervision and other technicians in planning for incoming samples. Independently prioritizes work schedule to ensure business needs are met on time. * Participated in activities to achieve American Chemistry Council's Responsible Care14001 certification * Worked ISO 9001 certified laboratory

Lafayette, Indiana, United States

Supported the Bulk Pharma and Fermented Products areas of Tippecanoe Labs using various analytical laboratory techniques (see description of Evonik Degussa resume) * Member of TL921 Lab Safety Committee. Resource on shift for safety related issues. Performed safety inspections. * Participated in TL921 Eluent Prep and Chromatography Integration Efficiency Six Sigma Project* Communicated with customers to handle sample load in lab and developed understanding of production processes to anticipate incoming IPC samples. Assists supervision and other technicians in planning for incoming samples. Independently prioritizes work schedule to ensure business needs are met on time.

Applied Good Manufacturing Practices when sampling chemical components and conducting tests on raw materials, in-process pharmaceuticals and finished products. * Performed various assays and tests on chemical components according to the United States Pharmacopeia/National Formulary. Approved the release of chemicals for use in products after testing.* Examined components and finished products for microbiological contamination. Prepped agar and other cell culture mediums. Plated raw materials to test for contamination. Helped count plates. * Prepared finished products for analysis via HPLC, IR, UV and other analytical techniques.* Assisted in developing new methods for testing finished products. * Trained new analysts in HPLC and wet chemistry techniques. * Investigated HPLC issues and assisted other analysts with assay issues.