Professional Experience Product Development
Resume:
Dharmesh Patel
*** ****** *****, *** *****, CA
********.***@******.***
Summary of Qualifications:
More than 12 years of experience in analytical and bio-analytical support laboratory.
Experienced in analytical and bio-analytical method development.
Operational knowledge of analytical instrumentation like Q-Exactive, LCMSMS, LCQTOF, GC-MS.
Proficient in quantitation, identification and characterization of organic compounds through analytical techniques.
Extensive knowledge of working in accordance with GLP requirements.
Experienced in operating, maintaining, installing, and troubleshooting analytical equipment.
Proven excellence in collaborative and independent performance.
Strong organizational skills with the ability to manage multiple project simultaneously.
Outstanding written and verbal communication.
Professional Experience:
LCMS Scientist January 2016 – April 2017
Fitbit, San Francisco, CA
Deliver analytical chemistry and mass spectrometry based solutions related to product safety and material biocompatibility from ideation to end of life of all hardware components.
Responsibilities:
Overseeing LCMS sample analysis workflow from initial submission to final quantitative analysis for raw materials and final products.
Design, develop, validate and troubleshoot new and existing sample extraction and analytical methods for LCMS based extractable and leachable (E&L) testing.
Enable rapid risk assessment by on schedule communication of results and overall processes to upper management and toxicologists.
Optimize analytical capacity by performing routine maintenance, cleaning, calibration, troubleshooting and repair of analytical equipment
Write standard operating procedures (SOPs) for analytical and data processing methods.
Accomplishments:
Supervised the installation and implemented of a Thermo Q-Exactive LCMS into the current sample analysis workflow.
Developed novel LCMS application for the identification and quantitation of E&L’s in wearable products
Implemented a high throughput informatics workflow using Compound Discoverer and Mass Frontier, combined with in-silico predictive MSMS fragmentation.
Evaluated and initiated the purchase of a new laboratory data management system with an ELN and sample management system to optimize overall workflow efficiency.
Senior Chemist
Chemist April 2005 – January 2016
Medtronic CardioVascular, Santa Rosa, CA
Supported analytical and bio-analytical chemistry efforts related to Drug Device Combination projects in which activities fall under R&D and GLP regulations.
Responsibilities:
Design, develop, validate and troubleshoot new and existing bio-analytical assays with multiple and single analytes for LC/MS/MS analysis in several matrices (arterial tissue, whole blood, brain, liver, & plasma)
in alliance with FDA guidelines
Support pre-clinical and R&D groups by providing pharmacokinetic data from exposure studies that include analyzing samples, interpreting data, writing reports, and presenting findings.
Collaborate with R&D and production groups within Medtronic to solve problems encountered during product development and manufacturing.
Create and execute analytical methods for GC-MS, LC/MS/MS, LCQTOF and HPLC-ELSD to identify and quantify extractables and leachables (E&L) from raw materials and finished medical device.
Design and manage leachable/extractable studies in support of PMA submissions for RA.
Coordinate bio-analytical development and validation efforts with contract laboratories.
Write standard procedures for bio-analytical procedures, validations and analyses.
Support the evaluation and procurement of new capital equipment.
Train co-workers on bio-analytical process and on LC/MS/MS systems for qualitative/quantitative analysis.
Fulfill system and database administrator duties for R&D and GLP Empower 2/3 database instances.
Perform instrument maintenance, calibration, troubleshooting, and managed service contracts for R&D & GLP equipment.
Accomplishments:
Developed new tissue, blood, and plasma assays for lipophilic drugs, which lowered the LOD significantly and enabled project teams to make better-informed decisions.
Established new methodology for obtaining smooth tissue suspension enabling improved reproducibility and robustness.
Selected to lead cutting-edge Empower 2 and 3-database upgrades for research & development group.
Served as an IT liaison for the chemistry group to communicate issues with computers and chromatographic systems.
Chosen to lead the evaluation of a new QToF mass spectrometer.
Research Scientist I
Exelixis Pharmaceuticals May 2002 - January 2005
Worked as part of a research team of 25 people that added 4 million compounds over 3 years to the internal compound collection for HT-screening as well as created shared compound libraries in collaboration with Merck, Schering-Plough, Scios, Elan Pharmaceuticals, and Cytokinetics
Synthesized small-scale organic compound libraries for evaluation as part of continuing internal drug discovery programs.
Responsibilities included: scheduling library syntheses, synthesizing compound libraries, completing post synthetic analyses of the libraries by LCMS, recording and reporting synthetic results, and preparing the compounds and associated data for either collection submission or shipment to corporate partners
Practical skills involved: thorough knowledge of solution-phase techniques involved in parallel synthesis; operation of Tecan liquid handlers, SpeedVac liquid evaporators, and the Ex-Blok reaction system; use of combinatorial chemistry software for the organization, handling and review of high volumes of electronic data
Operated and maintained robotic equipment.
Assistant Research Scientist I
ChemRX South San Francisco, CA January 2002 – April 2002
Worked in research and development doing combinatorial chemistry.
Carried out multi-step synthesis of small molecules using modern chemical laboratory techniques.
Responsible for testing and improving protocols of new library schemes for our corporate partner (Pfizer).
Synthesized necessary scaffolds for a library of approximately 5000 compounds.
Utilized both solution and solid phase chemistry to synthesize novel compounds which were analyzed on HPLC and LCMS.
Reported and presented data weekly to department.
Assistant Research Scientist I
GENENCOR INTERNATIONAL, Palo Alto, CA July 2001 – December 2002
Assisted on Polyesterase project for PNG (Proctor and Gamble).
Undergraduate Researcher – Natural product research from marine sponges
University of California Santa Cruz, Santa Cruz, CA September 1999 – June 2000
Senior thesis Advisor: Dr. Phil Crews
Specific research on marine sponge Acantenella Cavernosa obtained from Papa New Guniea in 1996.
Skills and Techniques:
Chemical: Analytical Chemistry, Medicinal chemistry, Combinatorial Chemistry, Wet Chemistry
Analytical Techniques: LCMSMS, QTOF-MS, Orbitrap, GC-APCI, GCMS, ELSD, FL, ECD, NMR, FT-IR, UV-Vis, RPLC, SPE,
Software: Excalibur, Compound Discoverer, Mass Frontier, Empower 2 & 3, Analyst, Masshunter Qual/Quant, Mass Profiler, Profinder, OpenLab, MassLynx, Chemstation, MiniTab, ChemDraw, LiveLink, Labvantage,, & MSVisio
Education & Professional Development:
B.S., Biochemistry and Molecular Cellular Developmental Biology University of California, Santa Cruz, Ca
Pharmacokinetics for Pharmaceutical Scientist Course, University of California, San Francisco (2012)
Statistics for Engineers/Scientist: Medtronic, Santa Rosa, Ca (2010)
MS Training
oPractical LCMS – Fundamentals, Techniques & Applications, By Jack Henion, CACO-PBS (2007)
oQ-TOF LC/MS Techniques & Operation for Small Molecule Application, Wooddale, IL (2013)
oQ Exactive (QE) and Excalibur Training, West Palm Beach, Fl (2016)
Waters Corp: Empower 2 Administrative Training Course, Dublin, CA (2007)
GLP Training: Annual Training for GLP Regulation 21 & CFR Part 58 & 11 (2005-2015)
Analytical Chemistry for Masters courses, Illinois Institute of Technology (2008-2010)
Poster Presentations:
“Enhanced Bio-Analytical UHPLC-MSMS Method for The Detection Of Rapamycin In Whole Blood Via Protein Precipitation And Solid Phase Extraction”, Science and Technology Conference, Minneapolis, MN October 2015.
Professional Memberships:
American Chemical Society (ACS)
American Society of Mass Spectrometry (ASMS)
Bay Area Mass Spectrometry Group (BAMS)
Pharmaceutical & Bioscience Society (CACO-PBS)
References available upon request.
Contact this candidate