Project Manager Data

Certifying Scientist

Laboratory Corporation of America Holdings (LabCorp)

September 2014 – Present (2 years)Raritan, NJ

• Review and certify negative and positive results for Federal and Non-Federal drug tests based on quality control acceptance criteria, immunoassay data, and interpretation of gas and liquid chromatography

• Successfully perform qualification protocols for validation of all confirmatory assays, reagents, calibrator and control materials

• Perform ethanol extraction in whole blood, serum and urine by Gas Chromatography Headspace

(GCHS)

• Document results on external Chain of Custody form as needed

• Knowledge of EMIT, DRI and CEDIA including SVT theories

• Profound knowledge of SAMHSA guidelines and principles of operation of screening instrumentation (Olympus), GCMS, LCMSMS, GCHS, pH meter, and refractrometer for specific gravity

ASSOCIATE PRINCIPAL SCIENTIST / PRINCIPAL SCIENTIST

Bioanalytical manager/scientist with the ability to conceive and apply creative solutions in developing and validating rugged bioanalytical methods (Listed below are some of the special recognition awards that I have received.) Bioanalytical project management including oversight of method development and assay validation both internally and at CROs. Review of analytical data for quality and adherence to both departmental SOPs and GLP guidelines. Independently plan, organize, and develop novel, sensitive, and selective bioanalytical LC-MS/MS, RIA, and ELISA methods to quantitate large and small molecule drug candidates in biological matrices from discovery, preclinical, and clinical development studies. Demonstrated communication skills to internal partners with respect to work progress. Ensure GLP compliance with respect to sample handling, assay validation, sample analysis, and instrument maintenance and calibration. Ability to deliver high quality GLP data under high scrutiny and tight timelines. Conducted on-site audits of CROs to evaluate GLP compliance and laboratory capabilities. Provide supervision to associates, guidance to supervisors, and counsel to management to ensure timely delivery of GLP-quality data to internal and external customers. Establish proficiency with & enable new technologies in sample preparation, liquid handling automation, and multi-dimensional hyphenated LC/MS to optimize analytical throughput. Knowledge of Masslynx, Softmax, Analyst and other data collection software, Watson LIMS, Rapid Documentum (report writing), IDBS Biobook (electronic notebook) and Microsoft Office Suite. Compile, review, and evaluate BA data; write SOPs, manuscripts, internal reports, and BA IND submission documents.

Special Recognition Award: Development of an ELISA assay to specifically measure serum concentrations of pegylated leptin while utilizing a solid phase extraction procedure to remove native leptin from human serum. The assay was used for both the Phase I and Phase II clinical studies.

Special Recognition Award: Successfully defended the bioanalytical portion of one of my GLP studies during an FDA audit and received a corporate service award.

Special Recognition Award: Elimination of an ion suppression problem associated with an IV formulation from a Phase II Clinical Study. The elimination of this problem ultimately led to timely delivery of quality data for the Clinical Team.

Special Recognition Award: Development of an LC-MS/MS method to stabilize and accurately measure an acyl glucoronide metabolite of a drug in human urine from a Phase II Clinical Study. The stabilization of this glucoronide led to a reliable method to measure both the parent compound and it’s metabolite in the same assay. This resulted in timely delivery of quality data for the Clinical Team.

Special Recognition Award: Development of an LC-MS/MS method to quantitate both the pre-hydrolysis concentration of an analyte as well as the post-hydrolysis concentration of the same analyte after the pegylated drug molecule was hydrolyzed to its free form.

PROFESSIONAL EXPERIENCE

HOFFMANN-LA ROCHE INC., Nutley, NJ

Associate Principal Scientist, DMPK

Develop, validate, trouble-shoot and improve automated bioanalytical ELISA and LC-MS/MS methods for the analysis of preclinical, clinical and animal GLP studies. Provide support to CROs.

Instruct junior scientists on ELISA and ECL techniques and method development, validation and GLP sample analysis.

Reference Standard Coordinator: Departmental liason between DMPK and PARD department to resolve reference standard problems.

Responsible for analysis of clinical and pre-clinical samples using validated ELISA and LC-MS/MS bioanalytical assays in-house or at CROs according to current SOP’s and regulatory guidance.

Proficient in the calibration, maintenance, and use of laboratory automation such as the Tomtec, and Biomek for sample processing and dilution.

Thomas J. Egan 973-***-**** p 2 of 3

As a laboratory and project manager I have supervised the work of several analysts through method development, validation and GLP sample analysis.

Preparation and review of departmental SOP’s, publication manuscripts, and study reports.

Ensure that cGLP status of facility is maintained. Regular calibration of LC-MS/MS and ELISA instruments and proper record keeping.

Prepare reports and documents for submission to regulatory agencies. Serve on local project teams as a bioanalytical project manager.

Proficient in the use of Analyst 1.4.2, Softmax Pro, Masslynx 4.0, Watson LIMS, Rapid Documentum (report writing), and IDBS Biobook (electronic notebook).

Senior Scientist, DMPK

Developed multiple LC-MS/MS assays for many drug candidates dosed simultaneously via an N-in one cassette dose.

Conducted preclinical cGLP studies under the scrutiny of internal auditors.

Record keeping and report writing that follows departmental SOP and GLP criteria.

Method development of several online extraction assays utilizing a Cohesive system.

Implementation of direct plasma injection assays developed for several discovery projects.

Comparison of whole blood versus plasma assays and determination of relative amounts of drug penetration into the red blood cells .

Designed a method to measure Adenosine (biomarker for asthma) in Monkey BAL Fluid.

Assay development and sample analysis for quantitation of drug levels in tumors and other tissues.

Scientist, DMPK

Prepared liver slice incubation Experiments to test in vitro metabolism of various new drug candidates.

Prepared liver microsomes and performed microsomal incubations of new drug candidates.

Conducted tissue distribution and mass balance studies for new drug candidates.

Cannulation, handling, and conduct of pharmacokinetic studies in laboratory mice, rats, and guinea pigs.

In vivo dosing (IV, IP, SC and PO) of new drug candidates in mice, rats, and guinea pigs.

Quantitation of radiolabelled drugs utilizing a Radiomatic detector.

Method development, validation, and GLP sample analysis of ELISA and LC-MS/MS assays for new drug candidates.

Met tight delivery timelines for final report writing.

Synthesis of fatty acid conjugates of Retinol (metabolites) and subsequent LC method development.

Thomas J. Egan 973-***-**** p 3 of 3

Method Development of a procedure to extract and quantitate antisense DNA strand from animal plasma utilizing HPLC-UV for detection.

Develop stabilization procedures for various peptides in animal and human plasma prior to their extraction and analysis.

Associate Scientist, Animal Science Department

As a scientist in the Animal Science Department, I was chosen to help advance an experimental initiative within the department. The initiative was to determine whether the administration of growth releasing factor to farm animals would increase the lean meat to fat ratio. My role in this process was to measure the concentrations of GRF peptide in animal blood utilizing various RIA methods. I also determined blood stability of various GRF peptides synthesized by a peptide group. I developed methods to extract the peptides from animal blood and analyzed the peptide concentrations via reverse phase HPLC.

Assistant Scientist I/II, Animal Science Department

As a scientist in the Animal Science Department, I quantitatively determined the concentration of veterinarian drugs in animal blood and urine. I was responsible for developing rugged analytical methods for this determination.

Flavor and Fragrance Scientist Elan Chemical Company

(A division of Felton International)

As a flavor chemist I was responsible for running synthetic chemical methods to produce various flavor reactions and determining by gas chromatography the yields of each reaction.

EDUCATION & PROFESSIONAL DEVELOPMENT

Seton Hall University South Orange, NJ

MS in Chemistry, minor in Business

University of Delaware, Newark, DE.

BS in Biology, minor in Chemistry

Completed several in house Pharmacokinetic Courses taught by Les Benet and Svain Oie from UCSF.

Took part in several LC-MS/MS courses taught by Dr. Jack Henion from Cornell University.

Participated in an offsite Immunological Methods Laboratory Course as an introduction to ELISA analysis of proteins in biological matrices.

RESEARCH PAPERS

Effects of LTB4 receptor antagonism on pulmonary inflammation in rodents and non-human primates Prostaglandins & Other Lipid Mediators 92 (2010) 33-43 February 27, 2010.

Discovery of Novel and Potent Leukotriene B4 Receptor Antagonists. Part1 Journal of Medicinal Chemistry 2010, 53, 3502-3516 November 17, 2009.

RO4383596, an orally active KDR, FGFR, and PDGFR inhibitor: Synthesis and biological evaluation Bioorganic & Medicinal Chemistry 13-200*-****-**** May 6, 2005.

Biological evaluation of a multi-targeted small molecule inhibitor of tumor induced angiogenesis Bioorganic & Medicinal Chemistry Letters 16-200*-****-**** December 21, 2005.

Pyrimidopyrimidine KDR/FGFR/PDGFR antagonist and it’s soluble prodrugs inhibit angiogenesis and tumor growth following oral administration Proc Amer Assoc Cancer Res, Volume 45, 2004 December 21, 2005

POSTERS

Utility of N-in-One PK Studies in Mice using LC/MS/MS for Early Drug Discovery. Zhenmin Liang, Tom Egan, Marcia Renzetti, John Roberts, Charles Harmon, Louise Gerber, Carole Baily, Surendra Bansal, and Anthony Greway Hoffmann-La Roche Inc., Nutley NJ

ABSTRACTS

Long Term Subcutaneous Infusion of Growth Hormone Releasing Factor (GRF) Analog RO 23-7863, in Rat C-M Su, LR. Jensen, T.J. Egan, P. Stricker, and T.F. Mowles Dept. Animal Science Hoffmann-La Roche Inc. Nutley, NJ

Contact this candidate