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 – 