Summary
Overview
Work History
Education
Skills
Select Publications
Timeline
Generic

Melanie Ivancic

Madison,WI

Summary

Accomplished Senior Research Scientist (Study Director) with extensive experience in bioanalytical chemistry, excelling in clinical biomarker analysis and project scoping. Proven leader in managing teams and mentoring scientists, driving successful GxP bioanalytical method development, validations, and sample analysis. Recognized for innovative problem-solving and effective communication, ensuring high-quality outcomes in complex projects.

Overview

19
19
years of professional experience

Work History

Senior Research Scientist (Principal Investigator)

Charles River Laboratories
06.2022 - Current
  • Evaluate technical feasibility of new proposals for the purposes of bidding new CRO contracts, and serve as the primary scientific point of contact for clients.
  • Serve as a manager and trainer for eight other principal investigators in small molecule, large molecule, biomarker method development, and fit-for-purpose method qualification.
  • Lead assigned projects, provide oversight of method development and GxP bioanalytical validations and sample analysis.
  • Perform scientific data review, data interpretation, and troubleshoot complex method issues.

Research Scientist (Principal Investigator)

LabCorp Drug Development
10.2017 - 06.2022
  • Led a 28-person FTE as the primary bioanalytical principal investigator for a major pharmaceutical client supporting clinical trials, clinical biomarkers, and CLIA studies.
  • Ensured the adherence of scientific data to criteria required for GxP in support of regulatory filings.
  • Provided technical leadership for a team of chemists, study coordinators, and project managers in pre-clinical and clinical investigations of drug candidates for a portfolio of 25+ pharmaceutical sponsors.

Postdoctoral Research Fellow

University of Wisconsin-Madison
05.2014 - 10.2017
  • Partnered with UW Hospitals and Clinics for a clinical pilot of human blood-protein biomarkers for colorectal cancer detection.
  • Developed commercialization strategy for blood-based biomarker panel with considerations of Series A investment and licensing through UW-Madison.
  • Assisted in the drafting of a patent application "Methods For Detection, Staging And Surveillance Of Colorectal Adenomas And Carcinomas." US-11933785-B2
  • Authored and secured two Wisconsin Alumni Research Foundation (WARF) grants and an NIH grant.

Graduate Student

University of Wisconsin-Madison
08.2008 - 05.2014
  • Designed and executed scientific experiments for investigating detection of blood protein biomarkers indicative of colorectal cancer using quantitative proteomics.
  • Collaborated with biostatisticians for analysis of inter-sample and intra-sample variation and defining applicable statistical significance for robust experimental design.
  • Assisted in the authoring of a patent application "Methods for the detection and treatment of colorectal cancer." US-11513123-B2

Research Associate

Amgen
05.2006 - 07.2008
  • Formulated and tested the physical and chemical stability of monoclonal antibody therapeutics for first-in-human clinical trials.
  • Led the development of a glycan analysis protocol for assessing similarities in competitors’ “biosimilar” products using LC/MS.

Education

Ph.D. - Biochemistry

University of Wisconsin, Madison
Madison, WI
05-2014

Bachelor of Science - Biochemistry

Purdue University
West Lafayette, IN
05-2006

Skills

  • Clinical biomarker analysis
  • Working within and interacting with CROs
  • Mentoring and managing teams
  • Project scoping
  • Bioanalytical chemistry
  • Protein biochemistry
  • Organizing and executing multiple projects at once
  • GxP for biomarkers, small molecules, and biologics

Select Publications

  • Ivancic, M.M., Megna, B.W., et al. (2020) Noninvasive detection of colorectal carcinomas using serum protein biomarkers. Journal of Surgical Research, 246, 160-169.
  • Ivancic, M.M, Anson, L. W., et al. (10 APR 2019). Conserved serum protein biomarkers associated with growing early colorectal adenomas. PNAS.
  • Ivancic, M. M., Irving, A. A., et al. (2014) The concentrations of EGFR, LRG1, ITIH4, and F5 correlate with the number of colonic adenomas in ApcPirc/+ rats. Cancer Prevention Research, 7(11), 1160-1169.
  • Ivancic, M. M., Huttlin, E. L., et al. (2013). Candidate serum biomarkers for early intestinal cancer using 15N metabolic labeling and quantitative proteomics in the ApcMin/+ mouse. Journal of Proteome Research, 12. 4152- 4166.
  • Ivancic, M. M., Gadgil, H. S., et al. (2010). LC/MS analysis of complex multi-glycosylated human alpha1-acid glycoprotein as a model for developing identification and quantification methods for intact glycopeptide analysis. Analytical Biochemistry, 400. 25-32.

Timeline

Senior Research Scientist (Principal Investigator)

Charles River Laboratories
06.2022 - Current

Research Scientist (Principal Investigator)

LabCorp Drug Development
10.2017 - 06.2022

Postdoctoral Research Fellow

University of Wisconsin-Madison
05.2014 - 10.2017

Graduate Student

University of Wisconsin-Madison
08.2008 - 05.2014

Research Associate

Amgen
05.2006 - 07.2008

Ph.D. - Biochemistry

University of Wisconsin, Madison

Bachelor of Science - Biochemistry

Purdue University
Melanie Ivancic