Graduate Assistant Qc Manager

MEI-LING BERMÚDEZ, PH.D.

Phone Number: 787-***-****, Email: ***************@*****.***

SUMMARY OF QUALIFICATIONS

- Scientist with progressive interdisciplinary experiences in diverse laboratories and industries, including Academic, Biotechnological, Contract Development and Manufacturing Organization (CDMO), Forensics, Microbiological, and Pharmaceutical

- Co-directed in-vitro, in-silico, pre-clinical, and clinical studies managing the testing of sterile, plant material, bacterial, animal, and human tissue samples

- Successful project management of new method validation and analytical instrumentation qualification, including chromatography (HPLC, UPLC, LC/MS, GC/MS), spectroscopy (FTIR, UV/VIS), among others

- Earned fellowships, scholarships, and research awards; attended and presented at international conferences; peer-reviewed publications

- Conducted research activities and documentation in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Institutional Review Boards (IRBs), United States Pharmacopeia (USP), and the International Organization for Standardization (ISO) regulations

- Strong leadership, mentoring, organizational, and interpersonal skills. Fluent in English and Spanish

EDUCATION

PhD, Environmental Genetics and Molecular Toxicology 2018 University of Cincinnati, College of Medicine - Cincinnati, OH

Principal Adviser: Dr. Mary Beth Genter

Thesis: Carnosine as a mechanism-based intervention in the Thy1-aSyn mouse model of Parkinson’s disease

Specialized Courses: Risk Assessment and Dose-Response Assessment

MSc, Biochemistry and Nutrition 2009

University of Puerto Rico, Medical Sciences Campus - Río Piedras, PR

Summa Cum Laude

Theses: Bioinformatic Analysis of the Polyketide Synthase (PKS) from Photobacterium profundum

BSc, Chemistry 2003

University of Puerto Rico, Río Piedras Campus - Río Piedras, PR

RESEARCH EXPERIENCE

Graduate Assistant 08/2012 to 10/2018

University of Cincinnati - Cincinnati, OH

- Designed and executed pre-clinical-based studies to identify the effective therapeutic dose, safety, and route of administration (including IN, SC, and PO dosing) using animal models of neurodegenerative diseases

- Led research activities to determine the efficacy of the treatment using neurobehavioral and biochemical tests

Analyzed molecular mechanisms of action using biochemical and bioinformatics techniques, such as immunohistochemistry (IHC), mitochondria functional assay using Seahorse Bioanalyzer, polymerase chain reaction (PCR), real-time PCR (RT-PCR), western blot, and RNA sequencing

- Evaluated the actions of endocrine-disrupting chemicals on stem/progenitor cells using proliferation, invasion, and migration assays

- Fostered an environment that encouraged continual process improvements and mentored fellows in the performance of laboratory procedures, animal welfare, data/statistical analysis, development of reports and presentations

Graduate Assistant 08/2007 to 12/2009

University of Puerto Rico - Río Piedras, PR

-Performed in silico analysis of the gene cluster of polyketide synthase (PKS) of the bacterium P. profundum

Identified conserved and no conserved regions of the polyketide synthase (PKS) gene cluster using the Udwary- Merski algorithm

PROFESSIONAL EXPERIENCE

Senior Scientist 11/2021 to Present

Resilience – Alachua FL

- Develop and optimize products-specific assay to test antibody and protein production from mammalian and bacterial cells lines in compliance with GMP regulations

- Represent the In-Process Testing team in clients’ internal and external meetings among cross-functional teams focusing on translating project goals into actionable items

- Supervise and coordinate laboratory activities with members of the team to evaluate the production of gene therapies and/or vaccines

Senior Scientist 08/2020 to 11/2021

ArrantaBio – Gainesville, FL

- Perform analytical development and tech transfer activities for microbial products in a cGMP environment

- Characterization of Live Biotherapeutic Products (LBPs) using anaerobic and microscopy techniques, potency

(CFU) assays, qPCR, and Sequencing, among others

- Direct and assist in the qualification, development of novel methodologies, and optimization of analytical methods for the analysis of Drug Substances and Drug Products Quality Assurance

Manager and LCMS Specialist 03/2019 to 08/2020 Kaycha Laboratories Gainesville, FL

- Assisted with laboratory start-up and accreditation activities in accordance with current and new regulations

- Review and assessment of events/investigations associated with batch records, SOPs, validation protocol deviations, and corrective action/preventive action (CAPA) process

- Optimization of multi-residue analysis method for the identification of pesticides and mycotoxins using Liquid Chromatography coupled to tandem Mass Spectrometry

Inventory, budget, instruments calibration logs, batch records, and non-conformance documentation on Laboratory Information Management System (LIMS)

Professional Services and Consultant 11/2018 – 09/2019 University of Florida – Gainesville, FL

- Collaborated with a project for the identification of clinical biomarkers of inflammation by transcriptomic analysis

Scientific Instrumentation Specialist 01/2010 to 08/2012 University of Puerto Rico - Río Piedras, PR

- Timely Project Management of a New High Throughput Crystallization Facility

- Designed and performed proteins crystallization experiments to study interactions of proteins with antagonists, ligands, or co-factors

- Collaborated with private companies and supervised graduate students during proteins overexpression, purification, and crystallization projects

Calibration Specialist, Validation Specialist, and Technical Support 09/2005 to 12/2007 VWR International - Manatí, PR

- Managed client accounts in the Pharmaceutical, Medical Devices, and Biotechnology industries

- Provided on-site troubleshooting, preventive maintenance, calibration, and minor repair of instruments, such as Particle Sizer, Melting Points, Karl Fishers, Titrators, HPLC, UV-Vis, GC, Dissolution Baths, FTIR, Microplate Readers, and Viscometers

- Technical writing of instruments qualification procedures (IQ, OQ, and PQ protocols), Standard Operating Procedures (SOP for Lancer Glassware Washer, HPLC, UV-Vis, GC, FTIR, and Ovens), Summary and Executive Reports

- Investigated and solved out-of-specification (OOS) and out-of-trend (OOT) testing results Stability Chemist 08/2004 to 08/2005

Combe Products, LLT - Naguabo, PR

- Performed method transfer validation for the company's new product to determine drug potency, reducing the cost of analysis and the time for results approval

- Evaluated chemical and physical of over-the-counter (OTC) products and assessed stability trends

- Established a procedure for reagent classification to ensure storage according to chemical properties

HONORS AND AWARDS

- North American Graduate Fellowship, American College of Toxicology (ACT) 2016, 2017

- New Investigator Scholar (NIS) Award, Center of Environmental Genetics, Cincinnati, OH 2014, 2016

- Greater Cincinnati Hispanic Scholarship Fund Scholarship 2016 Graduate Student Research Fellowships, University of Cincinnati, OH 2016

- Grant-In-Aid Research (GIAR) Awards, Chapter of Sigma Xi, University of Cincinnati, OH 2016 Hispanic Organization of Toxicologists Student Travel Award 2016

- Hispanic Chamber Cincinnati Scholarship, Hispanic Chamber Commerce, Cincinnati, OH 2015 Yates Scholarship, University of Cincinnati 2012

PUBLICATIONS

Vijayendran C, Bermúdez ML, Koka M, Chandran B, Pawale D, Vishnubhotla R, Alankar S, Maturi R, Subramaniam B, and Sadhasivam S. (2021) Large-scale genomic study reveals robust activation of the immune system following advanced Inner Engineering meditation retreat. PNAS.https://doi.org/10.1073/pnas.211*******

Bermúdez ML, Seroogy KB, Genter MB. (2019) Evaluation of Carnosine Intervention in the Thy1-aSyn Mouse Model of Parkinson's Disease. Neuroscience. PMID:31125602

Bermúdez ML, Skelton MR, Genter MB. (2018) Intranasal carnosine attenuates transcriptomic alterations and improves mitochondrial function in the Thy1-aSyn mouse model of Parkinson’s disease. Molecular Genetics and Metabolism. PMID: 30146452

Kopras E, Potluri V, Bermúdez ML, Williams K, Belcher S, Kasper S. (2014) Actions of endocrine-disrupting chemicals on stem/progenitor cells during development and disease. Endocr Relat Cancer. PMID: 24280134

Oyola-Robles D, Gay DC, Trujillo U, Sánchez-Parés JM, Bermúdez ML, Rivera-Díaz M, Carballeira NM, Baerga- Ortiz A. (2013) Identification of novel protein domains required for the expression of an active dehydratase fragment from a polyunsaturated fatty acid synthase. Protein Sci. PMID: 23696301

Contact this candidate