Training Medical

Summary

Bioanalytical Scientist with broad experience developing/validating methods

and analyzing samples in pharmaceutical, biotechnology and clinical

industries. Special expertise in developing quantitative analytical

methods using triple quadrupole mass spectrometry, HPLC and ELISA for small

molecules, peptides and proteins. Computer literacy with Analyst, Empower,

GraphPad Prism and all MS Office applications.

Experience

Sanofi Pasteur, Inc., Cambridge, MA

2009- 2010 Vaccines division of Sanofi Aventis.

Senior Analytical Development Associate

Developed and optimized quantitative ELISA methods for C. difficile toxoids

for stability testing of vaccine products.

Authored technical reports and SOP's to facilitate technology transfer to

manufacturing site.

Alkermes, Inc., Cambridge, MA

1996 - 2009

A pharmaceutical company specializing in drug delivery.

Scientist III (2002 - 2009)

. Developed quantitative analytical methods for novel small molecule

API's in non-clinical biological samples using LC/MS/MS (API 2000/API

3200) which led to the first IND filing for a NCE.

Managed laboratory operations in Life Sciences department including

acquisition, calibration, maintenance of equipment that produced GLP

compliance.

Audited CMC data in technical reports which lead to a successful NDA filing

for Vivitrol .

Devised and conducted stability testing experiments for dosing solutions

using Waters HPLC.

Served as Safety Committee liaison and implemented many improvements to

laboratory safety and ergonomics which brought the Life Sciences group into

corporate EHS compliance.

Principle Research Associate (1999 - 2002)

Investigated and developed immunoassay methods for proteins, peptides and

hormones for in vivo pharmacokinetic studies which supported ProLease hGH

(Nutropin Depot ) and BYDUREON (exenatide for extended-release injectable

suspension).

Collaborated with CRO by reviewing bioanalytical method validation

protocols for GLP and clinical studies.

Evaluated commercially available ELISA's to replace costly radioactive

assays.

Wrote technical reports, protocols, and SOP's to support INDs, CMC and

laboratory operations.

Senior Research Associate (1996 - 1999)

Hired, trained, and managed team of two Research Associates.

Transferred and cross-validated FSH MAIAclone for recombinant human

follicle stimulating hormone in rat serum to support formulation

development studies.

Developed and validated an ELISA for receptor mediated peptide, RMP7, which

was critical for conducting a Phase I/II clinical trial.

Applied Biosystems, Framingham, MA

1994 - 1996

Formerly Perseptive Biosystems, a biotechnology company that develops and

markets instrument-based systems to the life science industry and research

community.

Research Associate

. Developed ELISA's using solid phase immunochemistry for Integral

Workstations.

. Investigated a quantitative direct LDL cholesterol assay using cation

exchange chromatography and BioCAD.

. Provided expert knowledge of clinical laboratory needs for newly

formed Clinical Diagnostics division.

Previous Experience

Mayo Medical Laboratories New England, Wilmington, MA

Medical Technologist - Performed clinical laboratory tests in

chemistry and toxicology departments and provided clients with results for

diagnosis, treatment and disease prevention.

Dana Farber Cancer Institute, Boston, MA

Research Technician - Investigated oncogenic expression for colon,

bladder and breast cancer in mammalian cell lines using molecular

techniques including DNA and RNA isolation, Western, northern and Southern

blotting.

Education/Certification

Master of Science, Clinical Laboratory Science, University of

Massachusetts, Lowell, MA

M.B.A. courses, University of Massachusetts, Lowell, MA

Bachelor of Science, Health Science, cum laude, Merrimack College, North

Andover, MA

ASCP Technologist in Chemistry

Professional Training

Introduction to FDA Good Laboratory Practices, West Coast Quality Training

Institute

Medicinal Chemistry Short Course by Mark Wentland

Working Safely with Biopharmaceutical Compounds in R&D and Manufacturing,

Safebridge Consultants

Technical Writing Course

Radiation Safety Training

OSHA 10 hour safety training course

Professional Associations

Member, American Association for Clinical Chemistry

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