Steve Wintermute Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Seeking the door that has opened as this one gently closes.

Ensure continuous optimal performance of mass spectrometers. Troubleshoot instrumentation as needed and perform preventive maintenance daily. Establish daily runs. Process and review mass spec raw data from previous day. Create QC run reports. Manage/supervise seven mass spectrometrists.

Coordinate and oversee the transfer of analytical methods between contract laboratories and King Pharmaceutical laboratories. This involves reviewing, editing and approving method SOPs, validation reports and Method Transfer Protocols. Responsibilities include observing laboratory procedures and techniques of the 'sending' lab in order to facilitate a seamless transfer of methods to the 'receiving' lab; including subtleties and nuances that can affect the integrity of the transferred method.

• Develop, validate and execute HPLC-UV and LC/MS/MS drug assays in support of toxicology, mutagenic, dose-range-finding and clinical studies to progress drugs toward IND or NDA submission. • Applied diverse extraction techniques (SPE, protein precipitation, liq-liq, salting) to drugs in various biological fluids to achieve the lowest possible detection limits and satisfy study protocols. • Set up, calibrate and maintain instrumentation (autosamplers, pumps, detectors, liquid-handlers, robots) to ensure smooth method operation and uninterrupted sample analysis.• Interpreted raw data and authored bioanalytical summary reports needed for decisions to progress new drugs to market and extend marketed drugs to new indications.• Upgraded single-sample extraction methods to 96-well plate format to utilize emerging automation technologies (e.g. Hamilton STAR) for increased throughput.• Collaborated as an effective team member to deliver analytical results on time, with all data documented and reviewed, to meet aggressive timelines.

• Develop, validate and execute GC/MS, HPLC, LC/MS, LC/MS/MS assays or other analytical methods for qualitative and quantitative analyses in support of synthetic efforts, and preclinical and clinical studies.• Apply a variety of sample preparation procedures to isolate compounds and/or their metabolites from biological or other complex matrices. • Maintain analytical instrumentation in compliance with GLP regulations. • Maintain proper laboratory notebooks and study records, prepare data summary reports, and assist in the interpretation of chromatographic and mass spectral data. • Perform Direct Insertion Probe Mass Spectrometry (DIP/MS) for colleagues within the institute to assist in the verification of products of synthesis.• Provide GC/MS and LC/MS/MS support for institute scientists involved in a variety of research efforts.

• Developed, validated and/or executed HPLC and LC/MS/MS drug assays in support of toxicology, mutagenic, dose-range-finding and clinical studies to progress drugs toward IND or NDA submission. This included AZT (AIDS), Wellbutrin (depression, smoking secession), Naratriptan (migraines), Lamictal (epilepsy), Dutasteride (benign prostate hyperplasia, hair loss) and Septrin (pneumocystis carinii pneumonia AIDS complication, toxoplasmosis).• Applied diverse extraction techniques (SPE, protein precipitation, liq-liq, salting) to drugs in various biological fluids (plasma, serum, CSF, urine) and tissues (prostate, scalp, feces) to achieve the lowest possible detection limits and satisfy study protocols. • Set up, calibrated and maintained instrumentation (autosamplers, pumps, detectors, liquid-handlers, robots) to ensure smooth method operation and uninterrupted sample analysis.• Interpreted raw data and authored bioanalytical summary reports needed for decisions to progress new drugs to market and extend marketed drugs to new indications.• Programmed and operated Zymark Pi Robot System to fully automate sample preparation and analysis, freeing scientists for other tasks and increasing productivity.• Upgraded single-sample extraction methods to 96-well plate format to utilize emerging automation technologies (Zymark Rapid-Plate, Empore disks, etc.) for increased throughput.• Collaborated as an effective team member to deliver analytical results on time, with all data documented and reviewed, to meet aggressive timelines.• Revised and authored Standard Operating Procedures to ensure uniform operation and maintenance of several instruments throughout the company.

• Collect and analyze raw water samples from ground-water monitoring wells for targeted chemistry and pollutants.• Collaborate with industrial clients to investigate the suitability of ozonation for sterilization of (1) ultra high purity water systems for printed curcuit board production and (2) cooling tower water for the treatment of legionella bacterium. Set up, maintain and operate ozonation / sterilization pilot plants.