Summary
Overview
Work History
Education
Skills
Publications
Key Competencies
Qualifications Summary
Timeline
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Melissa Cramer

Summerville

Summary

Dynamic Laboratory Manager with a proven track record at Charles River, excelling in product development and process improvement. Expert in method validation and cross-functional collaboration, driving high-quality outcomes. Recognized for leading successful continuous improvement projects, enhancing operational efficiency, and delivering impactful results in laboratory settings.

Overview

19
19
years of professional experience

Work History

Laboratory Manager

Charles River
Charleston
03.2022 - Current
  • Spearheaded product and process improvements to manufacture high-quality endotoxin detection products efficiently.
  • Collaborated with cross-functional teams to investigate customer complaints and identify root causes.
  • Provided technical support and guidance for implementing changes and improvements.
  • Conducted testing on critical new materials, advising on risk assessments and providing verification data packages.
  • Led continuous improvement projects, ensuring the generation of high-quality products for internal and external use.
  • Supported new product development through laboratory testing, data package preparation, and implementation strategy development.
  • Interviewed, hired, and trained a lab technologist to perform experiments and analyze results.

Research Scientist

Arkley Biotek
Indianapolis
10.2016 - 12.2019
  • Conducted studies to enhance early detection methods for Alzheimer's Disease.
  • Led development of screening method for blood biomarkers in human serum samples.
  • Created long-term storage solution for lipoprotein-coated ELISA plates.
  • Developed method for identifying ApoE protein isoforms in human serum samples.
  • Established quality control measures through tracking system for pipettors and calibration certificates.
  • Authored SOPs for laboratory processes to ensure compliance and consistency.
  • Prepared data reports for presentations to potential investors, highlighting research outcomes.

Science Advisor, Microbiology

Cardinal Health
Indianapolis
03.2016 - 10.2016
  • Established microbiology quality control laboratory for startup radiopharmaceutical operation.
  • Delivered 100% of microbiology analytical validation methods, 93% of microbiology analytical methods.
  • Executed method validation for sterility, bioburden, and endotoxin analytical methods with unprecedented success.
  • Led environmental monitoring program, executing protocols and trending data efficiently.
  • Communicated effectively with internal teams at Cardinal Health and external microbiology contracting firms.

Technical Writer

Adecco Engineering & Technology for Cardinal Health
Indianapolis
09.2015 - 03.2016
  • Produced high-quality documentation for radiopharmaceutical quality control and laboratory startup.
  • Delivered 100% of GMP equipment user requirement specifications and 48% of SOPs and logbooks.
  • Achieved 94% cost savings by identifying a new sterilization technology for sterility testing isolator.
  • Led SOP team in coordinating assignments and tracking metrics for Cardinal Health leadership updates.
  • Collaborated with subject-matter experts to gather information and create clear, user-friendly documents.

Senior Molecular Biologist

Dow AgroSciences
Indianapolis
07.2009 - 06.2015
  • Led high-throughput method development and assay validation for TaqMan assays in Biotech Regulatory Sciences QC Lab.
  • Designed and implemented automation methods to enhance operational efficiency.
  • Championed multiple data quality advancement projects, achieving significant time and cost savings.
  • Ensured compliance with ISO 17025 requirements for validation and production data.
  • Served as Green Belt certified expert in root-cause investigations and quality oversight.
  • Recognized for exceptional performance through rapid promotions and selection for key initiatives.
  • Delivered DNA extraction and detection capabilities for soybean, cotton, and canola AP testing 10% ahead of schedule.
  • Directed Data Analysis Team, achieving record-setting processing of five million data points.

Laboratory Manager

Purdue University
West Lafayette
07.2006 - 07.2009
  • Managed laboratory operations focused on genetic and epigenetic influences on gene expression during fetal development and disease processes.
  • Supervised and trained graduate and undergraduate students in laboratory techniques and research methodologies.
  • Successfully established complete lab setup, achieving full operational status within four months.
  • Identified genetic location of missense mutation within 34 Mb region in under six months.
  • Uncovered genetic causes of five embryonic lethal mouse mutations through analysis of alternative splicing and non-coding RNA.

Education

Masters of Science - Biological Sciences

University of South Carolina
Columbia, SC

Bachelor of Science - Biochemistry and Biology

Virginia Polytechnic Institute and State University
Blacksburg, VA

Skills

  • Laboratory management
  • Data analysis
  • Technical documentation
  • Cross-functional collaboration
  • Regulatory compliance
  • Product development
  • Process improvement
  • Root cause analysis
  • Method validation
  • Research coordination

Publications

  • Lossie, AC, Baumgarner KM, Cramer MJ, Garner JP, Justice MJ, 2012, ENU mutagenesis reveals that Notchless homolog 1 (Drosophila) affects Cdkn1a and several members of the Wnt pathway during murine pre-implantation development., BMC Genet, 13, 106
  • Lo CL, Shen F, Baumgarner K, Cramer MJ, Lossie AC, 2011, Identification of 129S6/SvEvTac-specific polymorphisms on mouse chromosome 11., DNA Cell Biol, 31, 402-414
  • Cramer MJ, Haghshenas N, Bagwell CE, Matsui GY, Lovell CR, 2010, Celerinatantimonas diazitrophica gen. nov., sp. nov., a nitrogen fixing bacterium representing a new family in the Gamma proteobacteria., Int J Syst Evol Microbiol, 61, 1053-1060

Key Competencies

Design & Validation of Endotoxin Detection methods and supporting materials: Kinetic Chromogenic Analysis (KCA), Kinetic Turbidimetric Analysis (KTA), Endosafe Cartridge Systems, Gel Clot, Design & Validation of DNA Detection Methods, Genetic Testing for Low Level Presence (LLP)/Adventitious Presence (AP), DNA & RNA Extraction & Quantification, Sterility, bioburden, endotoxin, growth promotion and environmental monitoring testing, TaqMan PCR, Real Time PCR, Reverse Transcription & Sequencing, Nucleic Acid Analysis using Northern & Southern Blotting Techniques, Restriction Enzyme Digestion & Sodium Bisulfite treatment of DNA, Bacterial Characterization: Aseptic Technique, Media Preparation, Anaerobic Chamber Techniques, Transformation, Strain Cultivation, Ligation, Cloning & Denatured Gradient Gel Electrophoresis, Protein Analysis using Western Blotting and ELISA techniques, Experimental Design, Data Collection & Statistical Analyses, Synthesis of Data Records & Technical Reports, Quality Control Testing, Root Cause Analysis, Six Sigma (Certified Green Belt) & process improvement, Writing SOPs, URS & Best Practices, ISO 17025, GMP, GDP & Continual Improvement, JMP, LIMS, bespoke databases, Sequencher, eNotebook, Lab Archives, Vector NTI, Pilgrim, Graph Pad, EndoScan, Minitab, Lightcycler 480, Spectrophotometer, PheraStar, OmegaStar, KingFisher, Endosafe, Lumiscan, Multi-Cartridge System (MCS) Endotoxin Cartridge Reader, Portable Test System (PTS) Endotoxin Cartridge Reader, Bio-Tek Microplate Reader, Epoch 2 Plate Reader, Cellometer, Automation Experience: ViiA7 with Twister Arm, Beckman liquid handlers (MC & NX), Meridian, & MultiFlo liquid dispensers, Hydrocycler, Nexus robotic system

Qualifications Summary

Analytical, highly adaptable Microbiologist/Molecular Biologist with over 15 years of industry and academia experience. Skilled in experimental design, data collection and statistical analyses. Consistent track record of success with quality control and quality assurance testing. Accomplished communicator skilled in building and strengthening relationships across functions to drive cohesive, strategic operations.

Timeline

Laboratory Manager

Charles River
03.2022 - Current

Research Scientist

Arkley Biotek
10.2016 - 12.2019

Science Advisor, Microbiology

Cardinal Health
03.2016 - 10.2016

Technical Writer

Adecco Engineering & Technology for Cardinal Health
09.2015 - 03.2016

Senior Molecular Biologist

Dow AgroSciences
07.2009 - 06.2015

Laboratory Manager

Purdue University
07.2006 - 07.2009

Masters of Science - Biological Sciences

University of South Carolina

Bachelor of Science - Biochemistry and Biology

Virginia Polytechnic Institute and State University
Melissa Cramer