Latresa Copes
Philadelphia
Summary
Accomplished professional with expertise in regulatory compliance and analytical assays, honed at Amgen Biotechnology. Proven track record in project management and technical writing, driving successful IND submissions. Adept at coordinating cross-functional teams, enhancing product timelines, and ensuring GLP standards. Recognized for improving compliance processes, minimizing risks, and delivering impactful scientific documentation.
Overview
19
19
years of professional experience
Work History
Research Regulatory Operations Associate (CW)
Amgen Biotechnology
12.2023 - Current
- Ensured regulatory compliance throughout IND submission processes.
- Facilitated regulatory planning and development of essential documentation.
- Coordinated cross-functional meetings with scientists to align project objectives.
- Collaborated with product teams across functions to improve project outcomes.
- Supported nonclinical regulatory strategies to ensure compliance with industry standards.
- Monitored compliance with all regulatory processes to minimize risks.
Analytical Scientist
Janssen Pharmaceuticals
01.2021 - 06.2023
- Using downstream processes i.e., ELISAs assays to determine residual protein in client samples.
- Animal testing data: collected and analysed biomarker data for various strains of rats and mice (their urine and blood samples) for clinical research in kidney failure.
- Used PowerPoint and Excel in data analysis and presentations.
Analytical Scientist
Janssen Pharmaceuticals
01.2021 - 12.2022
- Using clinical analysers Alfa Wasserman, Luminex as well as ELISAs ran analytical assays to determine certain biomarkers which are indicators of kidney disease in rat and mouse urine and plasma samples.
- Animal testing data: collected and analysed biomarker data for various strains of rats and mice (their urine and blood samples) for clinical research in kidney failure.
Quality Specialist
Merck and Co.
01.2019 - 01.2021
- Quality assessment in Biological Critical Reagents (BCR)
- Updated Critical Reagent Protocols (CRPs) to QSIS program standards.
- Performed MRL dispension of Lyosheres.
- Used PowerPoint and Excel in data analysis and presentations.
- Involved in technical writing and revamping of SOPs, COAs and Deviations needed for the documentation of Biological Critical Reagents used for titters and vaccine development.
- Involved in technical writing and revamping of SOPs, COAs and Deviations needed for the documentation of equipment used in the BSL2 core for testing vaccines.
- Created runs and maintained Chain of Custody on received client samples prior to assay.
- Maintained precise GMP, GLP and GDP standards.
- Identified need of CAPAs for established SOPs.
- Trained newer techs in GMP/GLP requirements for assays.
- Used SOPs established in order to perform day to day job duties.
Research Specialist
Perelman School of Medicine, University of Pennsylvania
07.2016 - 06.2018
- Andrology study of sex ratio distortion in males exposed to environmental toxin 2,3,7,8, Tetrachlorodibenzodioxin (TCDD)
- Technical Writing: updating the lab’s molecular biology methods to be more current in methodology and reagents.
- Used PowerPoint and Excel in data analysis and presentations.
- Management of mice colony including dosing, genotyping and breeding of Aryl hydrocarbon receptor (primary receptor for TCDD) knock out models.
- Animal Testing data: ran a lab with a significant colony of mice that I oversaw as far as testing, ordering, creating KOs, and collecting and analysing data towards research in toxicology and a particular toxin in the reproduction of B6 male mice.
- DNA genotyping of mouse tissue using PCR and electrophoresis.
- Performed qPCR analysis of extracted mouse gestation day 15 embryos and early blastocytes for gender determination.
- Created and performed Western Blot assays and analysis on spermatozoa treated with environmental toxins.
- Created and performed sperm migration and motility assays using A CASA (Computer Aided Sperm Analysis) equipment as well as a custom designed 3D printed microfluid channel device.
- Performed FISH assay and analysis on mature sperm cells for X and Y chromosome determination.
- Performed ELISA and microarray assays.
- Performed assays for single cell analysis.
- Responsible for day-to-day maintenance of all lab standards included but not limited to: toxic and non-toxic waste disposal procedures, elimination of animal carcasses and blood, proper handling and disposal of glass, needles and other sharps, inspection and maintenance of -80 and -140 freezers, proper storage of hazardous, corrosive and flammable materials to comply with University of Pennsylvania’s EHRS requirements.
- Attend lab manager and animal user monthly meeting as well as annual online training.
Clinical Research Scientist
Nemours/A.I. DuPont Children’s Hospital
06.2015 - 05.2016
- Research in Tissue Engineering and Regenerative Medicine (TERM)
- Longitudinal study of Gadd45 gene family’s epigenetic results on rat skeletal muscle to investigate the gene’s behaviour in a non-pathological environment.
- Analysis of miRNAs in skeletal muscle of children diagnosed with Static Encephalopathy.
- Animal Testing data: data analysis in miRNA research in rat models for Cerebral Palsy.
- Trained in specific Regulatory Affairs regarding the use of IRB, IACUC, and OSHA's Chemical Hazard procedures for lab safety.
- Assays performed included but not limited to: Immunoprecipitation, mammalian cell culture, chromocytometry, flow cytometry, ELISA.
- Performed assays on mouse tissue for GADD45 protein consisting of: Western blotting, SDS page.
Graduate Research
Nemours/A.I. DuPont Children’s Hospital
01.2013 - 09.2015
- Research in Tissue Engineering and Regenerative Medicine (TERM)
- Longitudinal study of Gadd45 gene family’s epigenetic results on rat skeletal muscle to investigate the gene’s behaviour in a non-pathological environment.
- Analysis of miRNAs in skeletal muscle of children diagnosed with Static Encephalopathy.
- Animal Testing data: data analysis in miRNA research in rat models for Cerebral Palsy.
- Trained in specific Regulatory Affairs regarding the use of IRB, IACUC, and OSHA's Chemical Hazard procedures for lab safety.
- Assays performed included but not limited to: Immunoprecipitation, mammalian cell culture, chromocytometry, flow cytometry, ELISA.
- Performed assays on mouse tissue for GADD45 protein consisting of: Western blotting, SDS page.
Undergraduate research
Keck Institute
08.2009 - 06.2010
- Department of Material Engineering, Drexel University.
- Purified samples of HBV for engineering analysis of 'Attofluidic Nanotube-Based Probes' to be used for targeted drug delivery.
- Research was funded by the W.M. Keck Foundation.
Undergraduate research
Drexel University College of Medicine
12.2007 - 06.2010
- Analysis HBx protein expression during HBV replication.
- Bacterial transfection.
- Cloning of DNA vectors into plasmids.
Education
M.S. - Biological Sciences, concentration in Neuroscience
Delaware State University
Dover, DE01.2014
Undergraduate research - Analysis HBx protein expression during HBV replication, Bacterial transfection, Cloning of DNA vectors into plasmids.
Drexel University College of Medicine.
12.2010
Undergraduate research - Department of Material Engineering, Purified samples of HBV for engineering analysis of 'Attofluidic Nanotube-Based Probes' for targeted drug delivery.
Keck Institute
06.2010
B.S. - Biomedical Engineering, concentration in Tissue Engineering
Drexel University
Philadelphia, PA01.2010
Skills
- Regulatory compliance
- Analytical assays
- Technical writing
- Data analysis
- Standard operating procedures
- Project management
- Scientific document coordination
- Document management systems
- Product timeline creation
- GLP and GDP knowledge
Publications
- Bircsak K, Pranter A., Copes L., Gerton, G., The Role of the Aryl HydroCarbon Receptor in the TCDD-Mediated Sex Ratio Distortion., Biomedical Postdoctoral Research Symposium, Philadelphia, PA, 2017
- Copes, L.V., Akins, R.E., Developmental Expression of Gadd45 in Rat Skeletal Muscle., in preparation, Muscle and Nerve
Timeline
Research Regulatory Operations Associate (CW)
Amgen Biotechnology
12.2023 - Current
Analytical Scientist
Janssen Pharmaceuticals
01.2021 - 06.2023
Analytical Scientist
Janssen Pharmaceuticals
01.2021 - 12.2022
Quality Specialist
Merck and Co.
01.2019 - 01.2021
Research Specialist
Perelman School of Medicine, University of Pennsylvania
07.2016 - 06.2018
Clinical Research Scientist
Nemours/A.I. DuPont Children’s Hospital
06.2015 - 05.2016
Graduate Research
Nemours/A.I. DuPont Children’s Hospital
01.2013 - 09.2015
Undergraduate research
Keck Institute
08.2009 - 06.2010
Undergraduate research
Drexel University College of Medicine
12.2007 - 06.2010
M.S. - Biological Sciences, concentration in Neuroscience
Delaware State University
Undergraduate research - Analysis HBx protein expression during HBV replication, Bacterial transfection, Cloning of DNA vectors into plasmids.
Drexel University College of Medicine.
Undergraduate research - Department of Material Engineering, Purified samples of HBV for engineering analysis of 'Attofluidic Nanotube-Based Probes' for targeted drug delivery.
Keck Institute
B.S. - Biomedical Engineering, concentration in Tissue Engineering
Drexel University