Andrea V.

Clarke

*** ******* ******

Cambridge, MA

02141

646-***-**** / acf71f@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Over 13 years as a research scientist in a scientific lab environment at Regeneron Pharmaceuticals, The

Broad Institute and Shire Pharmaceuticals. Experienced in executing experiments utilizing a broad

range of scientific techniques. A careful and systematic approach to experimentation is emphasized to

ensure unambiguous results and effective problem solving. A personable, dedicated individual with

a can-do attitude. Excellent communication and strong organizational skills.

EXPERIENCE

Forma Therapeutics, Watertown, MA May 2014 – Present

Senior Research Specialist – Biology

• Cell-

based assay to determine IC50 of investigational compounds

• Proliferation assay using luminescence readout

• Monitoring and maintaining stable tumor cell lines for compound screening

• Analyze data from cell-based and proliferation assays using Activity Base software to determine %

inhibition and IC50

• Communicate analyzed data to project team

• Basic molecular biology including plasmid DNA t ransformation and amplification, isolation,

transfection of tumor cell lines, western blot analysis

• Attend weekly biology meetings

Shire Pharmaceuticals, Lexington, MA January 2012 -

April 2014

Senior Research Specialist – Non-clinical and Bioanalytical Development

• CRIM assay development by western analysis to assess patient treatment

• Maintained primary cell lines for cell-based assays and biochemical analysis

• Developed and validated quantitative bioassays (ELISA and MSD) in accordance with SOPs

and global regulatory guidelines

• Performed long term and short term stability studies of QC’s for validated SOP’s

• Wrote and reviewed SOP’s and Bioanalytical interim and final reports

• Performed quality review of assay results and data entry to ensure all data is valid and

compliant with appropriate internal SOP’s, global regulatory and CLIA guidances

• Executed assays within studies as per internal SOP’s, global regulatory and CLIA guidances

in a GLP environment

• Scheduled specimen testing, performed testing, analyzed data and interpreted data to generate

project reports and meet quarterly deadlines

• Maintained accurate, precise, legible documentation in compliance with appropriate regulatory

guidelines and internal SOP’s

• Contributed to BLA, NDA and IND filings by generating data tables and review of report

contents before submission

• Worked collaboratively with Clinical Teams and Data Management for various programs to

meet study timelines

• Received classroom training on LIMS

• Attended and presented at group’s bi-weekly meetings

Shire Pharmaceuticals, Lexington, MA October 2006 – December

2011

Research Specialist II - Bioanalytics and Biomarker Development

• Coordinated and organized study activities such as sample verification, tracking and data

generation across multiple assay platforms and programs

ANDREA V. CLARKE acf71f@r.postjobfree.com PAGE TWO

• Performed immunoassays (ELISA, MSD, Enzymatic Activity Assays) in a GLP and CLIA Certified

environment

• Collated results and assessed progress of studies to meet project deadlines and department goals

• Performed quality review of colleagues assay results, data entry and verified equipment and reagents

on data forms

• Trained colleagues on various assays and good documentation in accordance with internal

SOP’s in a GLP environment

• Contributed to BLA filings by generating calibrator tables, QC tables, and test sample result tables

• Wrote bioanalytical SOP’s for quantitative and qualitative ELISAs

• Reviewed data for interim and final study reports

• Made and reviewed clinical laboratory solutions and reagents according to SOP’s

• Attending Clinical Team meetings to ensure study timelines are met

Broad Institute, Cambridge, MA February 2006 –

September

2006 Research Associate II - Infectious Diseases Initiative

• Propagated and maintained cultures of malaria parasites at the merozoite stage for use in high-

throughput assays

• Contributed to the design and performed small-molecule, high-throughput screens for

identification of anti-malarial drugs

• Performed compound screening using proliferation and viability assays to evaluate their

effects on the merozoite stage of the malaria parasite

• Set-up the lab for the Malaria Initiative

Regeneron Pharmaceuticals, Tarrytown, NY June 2002 – October

2005

Research Associate II – Protein Chemistry Sciences

• Maintained multiple mammalian cell lines for the production of biologic therapies

• Evaluated the expression and characterization of recombinant proteins produced by

mammalian cells through FACS sorting, ELISA, and Western Blotting

• Performed routine protein analyses including SDS-PAGE, western blot and ELISA

• Performed studies to evaluate the stability of cell lines and expressed proteins

• Developed, optimized and validated DNA transfection protocols to ensure optimal cell

growth characteristics and protein production yields

• Basic molecular biology experience including plasmid DNA amplification, isolation, restriction

enzyme analysis by agarose gel electrophoresis and PCR

• Maintained experiments in laboratory notebooks

• Summarized and presented data to immediate group and at departmental meetings

Regeneron Pharmaceuticals, Tarrytown, NY August 1999 – June 2002

Research Associate I – In situ Core

• In-situ hybridization using reverse transcriptase generated 35S-labeled RNA probes for

detection of mRNA in tissue sections

• Fixed, sectioned and performed immunohistochemistry on various tissues

• RNA preparation and Northern Blotting using 32P-labeled DNA hybridization probes

• Some experience with small animals

• Plasmid DNA amplification, isolation, restriction enzyme analysis by agarose gel electrophoresis

• Accurately documented findings and lab records in laboratory notebooks

Regeneron Pharmaceuticals, Tarrytown, NY March 1999 – August

2002

Lab Assistant – Research

• Ordered and stocked research labs with reagents and supplies

• Prepared solutions and buffers

• Ordered chemicals and maintained common chemical room

EDUCATION

Bachelor of Science in Medical Technology

Graduation Date: 1999

YORK COLLEGE of the City University of New York, Jamaica, NY

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