Linda McGahen has over 25 years of experience in analytical chemistry and mass spectrometry. She has extensive experience developing validated assays for drugs and managing projects and analytical activities. Some of her qualifications include developing assays per regulatory standards, experimental design and data analysis to reduce costs, and identifying unknown degradation products. She has worked at several pharmaceutical companies and has a Ph.D. in analytical chemistry.
McGahen Resume-General-Sr Scientist-Anal Chem-Protein Chemistry-9 JUN 2015
1. Linda McGahen, Ph. D.
Sunnyvale, CA 94086 • 1-408-480-2114 • linda.mcgahen@gmail.com
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SENIOR SCIENTIST – ANALYTICAL CHEMISTRY
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KEY QUALIFICATIONS
Regulatory Compliant, Validated Assay Development ofQualitative and Quantitative Assays: Effective,creative
development of assays for drug product, pre-clinical or clinical studies per regulatory compliance standards (cGMP,
GLP / GXP; FDA / EMEA / EU / ROW); validated & used in-house or by CROs.
Project Planning & Management of Analytical & Team Activities: Successfulplanning of analytical activities and
managed teams to complete studies for multiple regulatory needs (e.g.,cleaning validations; long-term stability;
shipping studies for a refrigerated product).
Comprehensive,Effective Experimental Design & Data Analysis Exceeds Company Expectations & Results in
Cost Savings: Application of analysis methods salvaged temperature-tracked shipments of a refrigerated product
(savings = $400/bottle; up to ~$166,000/year).
Identify Metabolites or Elusive Degradation Products & Determine Their Genesis to Help Prevent or Reduce
Degradation Product Formation: Obtain and qualify reference standards of newly identified compounds.
Participate in Crises Resolution Efforts Within Complex Projects and Matrixes Teams: In highly matrixed team
efforts to evaluate complex projects in crises, identify areas that need improvement, suggest and achieve solutions
through solid analytical and communication skills. Commended for creative, out-of-the-box thinking and effective
participation in efforts to evaluate factors resulting in product variability.
Vendor / CRO Management: Assay transfer or development and validation; Pre-clinical / clinical sample analysis.
Stability Study Planning; Analyze Data; Set Specifications; Determine Expiration Dates; Investigate OOS /
OOT Results.
Excellent Communication and Presentation Skills.
Impeccable Integrity and Work Ethic; Capable of Aligning Team Members Using Positive Methods to
Accomplish Goals and Develop Personnel.
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TECHNICAL EXPERIENCE / SKILLS
Liquid or Gas Chromatography –
o HPLC:Nano-LC to Semi-prep; Fast LC; UPLC; Flash Chromatography
o Chromatography Phases – RP,HILIC,ZirChrom, CN, SEC/GPC, IEX, Chiral, etc.
o Detectors:HPLC – PDA/UV,Fluorescence (FLD),ELSD,RI; GC - FID, Hall (NPK),EC
Mass Spectrometric Analysis and Interpretation
o Ionization for LC-MS or GC-MS or MS/MS (ESI, APCI,CI, EI, MALDI,CID, etc.)
o GC- or LC-MS or -MS/MS Analysis of Small Molecules, Polymers, Proteins/Peptides Mapping
(MASCOT,SwissProt, BLAST)
Sample Extraction, Clean-up, Derivatization, Separation, Fraction Collection to Identify Unknowns
Use of Radiolabeled and Non-radiolabeled Tracers
Solid State Characterization: Light Scattering (DLS), FTIR, NMR (1H, 13
C; 1-D & 2-D COSY), DSC/TA
Software:
o Data Acquisition Software and LIMS: Agilent Chemstation/MassHunter; Waters Empower
o ChemDraw Ultra • MicroSoft Office • Data & Statistical Analysis Software (JMP)
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PROFESSIONAL EXPERIENCE & SELECTED ACCOMPLISHMENTS
Agilent Technologies, Inc. – Santa Clara,CA 2012 - 2014
Program Manager (Contract for 17 months)
Managed the completion of the Phase II portion of a DARPA-Agilent-funded project analyzing gas mixtures of 300
compounds utilizing newly developed GC/MS equipment. Prepared compound libraries of the MS data for each
2. Resume – Linda McGahen, Ph. D.
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ionization source; calculated linearity over wide concentrations; prepared presentations and reports for Agilent’s upper
management and DARPA. Equipment included, in part: experimental ion sources and a High Resolution Time of
Flight Mass Spectrometer (HRTOFMS; in development; the mass accuracy is 10X higher than commercial TOF
systems and matched that of FTMS systems). Sample introduction: an ENTECH 7032AB-L cryofocusing autosampler.
Sample separation: Agilent’s ultrafast cooling LTM GC column (UFC-LTM).
ForSight Labs, LLC, Vision 5 – Menlo Park,CA May – Nov 2011
Sr. Method Development Chemist (Contract)
Developed an HPLC method to quantitate total bimatoprost and bimatoprost that eluted from the drug device.
GL SCIENCES, Inc. USA – Sunnyvale, CA (Main office - Torrance,CA) Sep - Dec 2009
Sales Account Manager - Western Territory
Chromatography-related sales: INERTSIL®
HPLC Columns; FAST LC upgrades achieving UPLC performance on
normal gradient HPLCs; excellent service and application support to customers.
UCLA – The Pasarow Mass Spectrometry Laboratory – Los Angeles, CA Aug-Sep 2008
Senior Visiting Scientist (with Professor Julian Whitelegge, Ph. D.)
Conducted experiments to optimize peptide digestion of acylated pig HDL (Apo AI and AII); extracted peptides and
analyzed them using microbore LC/MS/MS (C4 or HILIC with data-dependent acquisition procedures) to discern the
location(s) of steroylation (CH3(CH2)16COOH),a post-translational modification.
ALZA Pharmaceuticals, Inc, Mountain View, CA (bought by JnJ) 1999 - 2006
SEQUUS Pharmaceuticals, Inc, Menlo Park,CA (bought by ALZA) 1990 - 1999
Senior / Research Scientist / Analytical / Stability
Identified an elusive, polar unknown (LC/MS/MS, FTIR and NMR) and had a reference standard synthesized &
qualified. Utilized pKa mapping to develop a unique, highly re-optimized, “one-shot” HPLC assay that collapsed
three poor assays into one good method (~67% reduction in analytical time).
Product Crises Resolution: Worked with highly matrixed teams towards investigating products to improve the
product, raw materials, analytical procedures, or other causes of failures or OOS / OOT results.
Developed assays for in-house or CRO analysis of doxorubicin HCl in preclinical and clinical samples.
Designed an Arrhenius kinetic study: the results permitted determination of the acceptability for use of a
refrigerated product following documented temperature excursions (saving ~$77,000 - $166,000/year).
Procured a variety of instruments or worked with CROs to develop analyses of products or raw materials for
Regulatory purposes (e.g., in-house: headspace GC; CRO: LC-MS of MPEG-DSPE for polydispersity).
ZENECA AG CHEMICALS, Mountain View / Richmond, CA < 1990
Senior / Research Scientist / Metabolism Group
Investigated the fate of 14
C-labelled pesticides in soils and crops (photolysis, degradation to 14
CO2,metabolism);
isolated and identified degradation products and metabolites.
EDUCATION
Ph.D.: Michigan State University, East Lansing, MI: Identified unique, previously unreported thiomethylated
degradation products from two 14
C-labelled acetanilide herbicides incubated in an anaerobic lake sediment.
M.S.: Michigan State University, East Lansing, MI: Identified 7 - 8 degradation products; outlined degradation
pathways of two 14
C-labelled acetanilide herbicides transformed by a soil fungus, C. globosum.
B.S.: Pennsylvania State University,University Park,PA
CURRENT/PAST MEMBERSHIPS IN SCIENTIFIC / PROFESSIONAL SOCIETIES
American Society of Mass Spectrometry (ASMS)
Bay Area Mass Spectrometry (BAMS)
American Chemical Society (ACS)
Pharmaceutical& BioScience Society-SF Bay (PBSS)
Golden Gate Polymer Forum (GGPF)
CA Separation Science Society (CaSSS)
Available for Travel –