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Senior Associate Scientist Resume Sample


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SENIOR ASSOCIATE SCIENTIST
RESEARCH AND EXAMINATION | RESOURCE MANAGEMENT | DATA ANALYSIS, EVALUATION, AND DEVELOPMENT

Innovative, enthusiastic, and highly skilled research and development professional, with progressive years of experience in pharmaceutical studies focused on active pharmaceutical ingredients. Possess solid background in MRA/FDA auditable laboratory along with proficiency in GMP laboratory practices. Reliable and solutions-focused leader, adept at conducting initial research, facilitating data analysis, as well as evaluating and developing viable solutions for integration into the market. Creative thinker recognized for innovative vision, high ethical standards, and the ability to communicate effectively across management levels and disciplines to build highly effective cross-functional teams. Knowledgeable hands on use of the following instrumentation:

  • High-Performance Liquid Chromatography/Mass Spectrometer (HPLC/MS)
  • Karl Fischer Moisture Analyzer (Volumetric and Coulometric)
  • High-Performance Liquid Chromatography
  • Atomic Adsorption (AA)
  • Ultra Performance Liquid Chromatography
  • Nuclear Magnetic Resonance (NMR)
  • Fourier Transform Infrared Spectroscopy
  • Supercritical Fluid Chromatography (SFC)
  • Powder X-Ray Diffraction (PXRD)
  • Ultraviolet-Visible Spectrometer
  • Residue on Ignition (ROI) by USP
  • Gas Chromatography (GC) and Headspace GC
  • Inductively Coupled Plasma (ICP)
  • Total Organic Carbon
  • Mass Spectrometer
  • Raman 1064/768 nm

Technical Skills: Empower, Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), Microsoft Office Suite, TrackWise, M3 PeopleSoft, General Document Management Software (GDMS), OMNIC software for the FT-IR, ACD/SpecManager for the NMR, Galaxy, Ariba, eBuy, Citrix, and SumTotal.

PROFESSIONAL EXPERIENCE

PFIZER, GLOBAL R&D, GROTON ANALYTICS, Groton, CT
Senior Associate Scientist | 2010-Present

  • Leverage skills in testing active pharmaceutical ingredients, solid dose drug product, and raw materials using various USP and EP methods for GMP Quality Control release.
  • Accurately identify raw materials for release and use in the kilogram laboratory through proper application of handheld Raman TruScan 785nm spectrophotometer and Bayspec 1064 nm spectrophotometer.
  • Utilize UV/Vis, GC, and LC-MS in developing clean by test (CBT) methods for active pharmaceutical ingredients (APIs) for the kilogram laboratory.
  • Encode all tests report and procedures performed in the laboratory through Symyx Notebook.

Career Highlights:

  • Played a major role in setting up and testing the handheld Raman used in raw material release for the kilogram laboratory within receiving, eventually expediting the release time of a material.
  • Completed the complex analysis of the handheld Raman as a replacement for the PXRD in identifying the crystalline form of Active Pharmaceutical Ingredients (API), along with its use as the identity testing for excipients and post-pack in solid drug products.
  • Gained comprehensive knowledge in testing finished solid dose drug products and differences from API release.
  • Ensured safety of drug for extended period of time and its various storage conditions employing broad understanding of stability protocols and necessary testing procedures.

PFIZER, GLOBAL R&D, SUPPLY CHAIN ANALYTICAL CONTROL, Groton, CT and Ann Arbor, MI
Senior Associate Scientist | 2006-2010

  • Facilitated the testing of APIs in-process and finished samples from the R&D research kilogram laboratory for assay and potency using HPLC and various USP and EP methods, assuring compliance with Pfizer and Food and Drug Administration (FDA) guidelines for release into clinical and stability protocols.
  • Utilized various USP and EP methods for Quality Control GMP release in experimenting active pharmaceutical ingredients and raw materials.
  • Made use of Waters Empower software in running and processing HPLC sequences on Agilent 1100 systems.
  • Performed complex testing on in-process control samples for the Kilo Lab with off shift and weekend support.
  • Delivered exemplary service in performing spectra scans through an Oxford AS/400 NMR with VNMR software and ACD/SpecManager 9.0 software to ID compounds, along with routine identity scans with the use of a Nicolet Nexus 470 FT-IR with OMNIC version 6.2 software.
  • Successfully completed training on a Bruker AXS D8 ADVANCE X-ray diffraction instrument to determine crystal form of active pharmaceutical ingredients utilizing DIFFRACplus software as well as on Bruker S4 Explorer X-ray fluorescence instrument for research for heavy metal content.
  • Accomplished analysis to determine water content applying coulometric/volumetric Karl Fischer.
  • Engaged in the proficient testing for residue solvents in active pharmaceuticals ingredients using HP 6890N GC with G1888 headspace autosampler and Perkin Elmer Autosystem XL GC with a TurboMatrix 40 Headspace autosampler.
  • Directly supervised the transfer of cGMP instruments and the installation of new instruments in a new cGMP laboratory.

Career Highlights:

  • Ensured availability of all raw materials necessary to manufacture clinical batches of new active pharmaceutical ingredients through close interaction with pilot plant personnel.
  • Effectively served as point-of-contact for all API raw material testing at Pfizer Global R&D site in Groton.
  • Obtained proficiency in various methods and instrumentation for testing and release as well as in discovering and identifying path of a new molecule within Pfizer research, including the setup and use of PXRD by a Bruker representative.
  • Helped in developing UPLC Skin Flux Quantiation method for PF-00251802, PF-04171327, Clobetasol, Propionate, and Hydrocortisone.

PFIZER, GLOBAL SUPPLY CHAIN, Kalamazoo, MI
Associate Chemist II | 2002-2006

  • Achieved accurate results through testing of APIs in-process and finished samples for assay and potency using HPLC, guaranteeing conformity with Pfizer and FDA GMP guidelines for release into finished drug products.

Career Highlights:

  • Played a lead role in developing an HPLC method for an API based on the EP assay while performing IQ/OQ on new HPLC instruments in the laboratory as well as validation protocols on existing and new HPLC methods per ICH and Pfizer guidelines.
  • Demonstrated expertise in researching and establishing suitable column replacement for the spectinomycin assay that was using up columns at a fast rate.

EARLIER EXPERIENCE

Analyst, PHARMACIA, GLOBAL SUPPLY CHAIN, Kalamazoo, MI | 2001-2002
Assistant Chemist II, ABBOTT LABORATORIES, ROSS DIVISION, Sturgis, MI | 1996-2001

EDUCATION

Master of Science in Chemistry | THE UNIVERSITY OF RHODE ISLAND, Kingston, RI | In Progress
Bachelor of Science in Chemistry | Minor in Math, WESTERN MICHIGAN UNIVERSITY, Kalamazoo, MI | 1996
Coursework toward Chemical Engineering | MICHIGAN TECHNOLOGICAL UNIVERSITY | Houghton, MI

PROFESSIONAL TRAINING

Empower Advanced: Acquisition, Processing, and Reviewing Results
Transitional Topics from Empower 1154 to Empower 2154
TrackWise Team Access Quality Management Software
Good Manufacturing Practice (GMP) Compliance for Quality Control Laboratory Operations
Advanced High-Performance Liquid Chromatography (HPLC) Method Development
Practical High-Performance Liquid Chromatography (HPLC) Troubleshooting

AWARDS AND HONORS

Individual Performance Awards (2)

ACTIVITIES AND AFFILIATIONS

Member, American Chemical Society
Lifetime Member, Alpha Phi Omega, a National Service Fraternity
Den Leader of Pack 12 Bears, Boy Scouts of America

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