Experience

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  Perrigo Nutritionals

  • Milton, Vermont

  • Manager, Analytical Research & Development

    • Jun 2013 - Present
    • Milton, Vermont

    Balancing dual role of manager and individual contributor supporting Technical Services, Product Development and Quality Control departments. As a manager supported filings with the FDA for NBEs, assigned projects to staff, monitored AR&D budget, conducted performance appraisals, leveraged situational leadership styles for direct reports, facilitated method transfer into QC, implementing a Sensomics program (VOC isolation, VOC potency by AEDA, VOC quantitation by SIDA, aroma profile replication by recombinant/omission), and coordinated method development and transfer to external CROs. As individual contributor developed numerous analytical methods including tracking heat mediated reaction products, Human Milk Oligosaccharide by HILIC-FLD& HPAEC-PAD, Trace milk allergen by immunoassays & LC-MS/MS, Protein Hydrolysate molecular weight profile by HPGFC-UV, Peptide fingerprinting by RPLC-UV, whey protein denaturation, phospholipid quantitation by HILIC-MS/MS, etc.

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  Upsher-Smith Laboratories

  • Senior Chemist II

    • Jun 2010 - May 2013

    Performed lab functions including method development, method validation, unknown identification, drug product testing. Wrote documents for work instructions, methods, development reports, validation reports, protocols, and Common Technical Documents (CTD). Participated on multiple cross-functional teams. Supervised one direct report. Developed cross-functional Access databases for analytical requests, chromatography columns, and CRO/CMO information. Led the identification of the origin for multiple unknown peaks observed in chromatograms for an ER anti-epilepsy product using LC/MS. Led the identification and quantitation of multiple unknowns peaks observed in GC chromatograms for an ER anti-hypokalemia product using GC/MS. Led the analytical portion of an ANDA project, for a dual active drug product, from inception to electronic submission. Utilized QbD principles to develop a reversed-phase gradient HPLC method for separation of two APIs and their related substances.

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  Boston Scientific

  • Manager I

    • Jun 2004 - May 2010

    Supervision of 4 direct reports who perform method development and validation. This includes assigning, reviewing and discussing analytical work/documentation, guiding in setting realistic/challenging objectives for each year, counseling, training, and mentoring. Researched current state-of-the-art technologies for heart valve transplants with emphasis on prevention of calcification. Coordinating drug release rate analyses of various drug-eluting medical device formulations. This includes method development for a labile Olimus drug, a steroid, a tetracycline, an aminoglycoside, and taxol with good IVIVC, investigation of stability, sink conditions, increasing detection sensitivity. Coordinated the purchase of a HPLC interfaced hybrid triple quadrupole/linear trap mass spectrometer for trace level detection, unknown mass determination, structural elucidation, and degradant analysis. Coordinated the evaluation of various quasi-universal HPLC detectors including Corona CAD and sub-ambient ELSD which lead to the purchase of the sub-ambient ELSD for quantification of compounds with poor UV chromophores including triglycerides and aminoglycosides. Writing deviations, laboratory investigations, protocols, reports, methods, equipment specifications, equipment use SOPs, and other standard operating procedures. Lead small team to evaluate a polymer-free bio-absorbable triglyceride-based drug delivery technology. Lead small team to develop analytical methods to support a project evaluating a biodegradable polymer/Olimus drug-eluting stent technology.

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  Purdue Pharma L.P

  • Scientist to Section Leader

    • Apr 1995 - Jun 2004

    Supervision of 5 direct reports who perform methods development and methods validation, including assigning, reviewing and discussing analytical work/documentation, writing/conducting annual performance evaluations, setting realistic/challenging goals and objectives for each year.Analysis (assay, related substances, dissolution, Karl Fischer, hardness, etc) of formulations (in accordance with cGMP guidelines) on stability to generate data for INDs, sNDAs, NDA.Writing procedural exception requests, investigations, stability reports, notebook & assay report addendums, analytical methods, qualification protocols, method validation protocols, and method validation reports.Develop Dissolution USP 3 methodology to simulate GI tract for MR MEM product.Develop dissolution methodology for various dosage forms (tablets, capsules, micro-encapsulated parenteral) with good IVIVC.Trouble shoot, repair, calibrate, and qualify instruments to assure cGXP compliance.Development and validation of analytical methods in accordance with FDA, USP, ICH guidelines to analyze new products, formulations, and excipients.

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  Biocraft Laboratories

  • R&D Chemist

    • Jul 1993 - Apr 1995

    Analysis of raw materials and various dosage forms on stability to generate data for ANDAs.Troubleshoot & calibrate lab instruments, qualification of HPLC systems, and validation of USP methods.

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  Schein Pharmaceuticals

  • Junior Chemist/ Metrologist

    • Feb 1990 - Jun 1993

    Performed process validation testing in accordance with USP or in-house procedures.Calibration of instruments in QC, R&D, and manufacturing area of two plants.Development, validation, and writing of calibration procedures.