Irena Riley
Philadelphia,PA
Summary
Creative learner and thinker with Seven + years of substantial experience in: biopharmaceutical, clinical, and pharmaceutical manufacturing settings.
Overview
7
7
years of professional experience
Work History
Validation Engineer - Cleaning Validation
Yoh Scientific Contractor at Kenvue
Fort Washington, PA
02.2023 - Current
- Assist with the execution of validation projects and development projects and studies, including sampling in the liquids manufacturing/packaging areas
- Coordinate and prepare documentation related to the execution and maintenance of the validation program, including: development of product/equipment cleaning procedures, study/protocol design, documentation
- Participate in cross-functional teams to develop the most optimal validation strategies.
- Resolution of any issues that arose during the course of validations by troubleshooting problems as they occurred in real time with Team Leaders.
- Schedule validation testing with different departments and managers.
Scientist - Large Molecule Biologics and Bioassays Toxicokinetic/Pharmacokinetics and Anti-Drug Antibody
Frontage Laboratories
Exton, PA
11.2021 - 11.2022
- Perform as PI and manage the overall planning, execution, and quality of assigned Method Development, Method Validation, and Sample Analysis Projects
- Principal Investigator and Scientist responsible for FTE Studies
- Attend technical discussions with Clients/Sponsors
- Lead FTE Teleconferences
- Assist Principal Investigators in maintaining project quality, meeting compliance requirements, and timelines
- Write reports for Method Development, Method Validation, and Sample Analysis stages for various studies
- Prepare laboratory notebooks, study binders, data packets, data summaries, methods and qualifications, and protocols
- Monitor reagent and laboratory consumables and coordinate with procurement team appropriately to ensure lab operations continue smoothly
- Assay design and troubleshooting of assays
- Mentor and train other Scientists
- Daily tasks include performing: Immunogenicity assays (vaccine and anti-drug antibody assays), Meso Scale Discovery Assays, Electrochemiluminescence Immunoassays, utilization of Gyros Platform to conduct Immunoassays, Immunofluorescence Assays, and, HPLC-MS/MS
Microbiologist II - Virology and Serology
Pennsylvania Department of Health
Exton, PA
05.2020 - 11.2021
- Use advanced microbiological and biomolecular laboratory techniques in the examination of samples and specimens
- Diagnose patients with infectious diseases such as: Zika, West Nile Virus, Enterovirus, Measles, Mumps, Influenza A and B, Human Rhinovirus, and many other upper and lower respiratory viral and bacterial pathogens
- COVID-19 tester: Routinely perform diagnostic testing for the detection of SARS-CoV-2 by RT-PCR
- Lead Microbiologist for SARS-CoV-2 Antibody testing at PA Department of Health using serological methods
- Frequent Collaboration with CDC to promote Public Health
- SOP writing
- Corrective Action Report (CAR) writing and analysis
- Perform sample reception and pre-analytical checks
- Perform QA checks in the analytical phase using the quality controls to ensure the accuracy of the tests
- Perform and evaluate new diagnostic procedures to determine the performance characteristics and/or suitability for the laboratory
- Use laboratory information management system (LIMS) to access specimens, manage the samples through the testing processes and report the laboratory testing results to laboratories and public health partners
- Participate in proficiency testing to ensure that the State Lab maintained a high quality of testing for molecular detection of different viruses and typing and subtyping in compliance with CLIA regulations
- Provide customer service via telephone to submitting agencies by providing timely laboratory results and laboratory status update that aid in the decisions about diagnosis, effective treatments, and control efforts.
Scientist - Cellular and Molecular Biology
Eurofins
Lancaster, PA
02.2017 - 05.2020
- Provide Biopharmaceutical services to many projects in the Biopharmaceutical industry which include: Clinical Trial registration, Commercial stability testing, full stability and release testing for clinical trial drug products and substances, stability storage and product retain programs
- Extensive training in knowledge in laboratory procedures, tests, instruments, reagents, and controls
- Experience in the development of client specific projects for both FTE and non-FTE programs
- Perform routine and non-routine testing for different molecular assays
- Qualification, validation, or transfer of client specific projects
- Mentored on processes and procedures relevant to tasks at hand to newly hired employees, for example: train new Analysts and Cell Culture Technicians on cGMP/GLP, routine testing, and assist with any questions
- Schedule Routine Testing and Cell Maintenance for Analysts and Cell Culture Technicians
- Develop and write forms for laboratory notebooks and Electronic Laboratory Notebooks (ELN)
- Utilization of the eJIRA system
- In-depth understanding of ELIMs and Electronic Laboratory Notebooks (ELN)
Education
Bachelor of Arts - German Language, Culture, Literature, And History
Millersville University of Pennsylvania
Millersville, PA12.2016
Bachelor of Science in Biology -
Millersville University
12.2016
Chemistry Minor
Millersville University of Pennsylvania
Millersville, PA12.2016
Skills
- Extractables/Leachables Testing
- USP Assays
- Effective Communication
- Evaluation of Engineering Systems
- Testing Protocols
- Report Writing
- Audit Processes
- Critical Thinking
- Regulatory Compliance
- Data Integrity
- Organization
Affiliations
- EHS Ergonomics Team
- EHS CPR/First AID Team
- Interpreter/Translator
- Model
- Adjunct Biology Professor
- 500hr Yoga Instructor
- Study Abroad 02/2016-08/2016
Languages
English
Native/ Bilingual
Haitian Creole
Native/ Bilingual
German
Full Professional
Timeline
Validation Engineer - Cleaning Validation
Yoh Scientific Contractor at Kenvue
02.2023 - Current
Scientist - Large Molecule Biologics and Bioassays Toxicokinetic/Pharmacokinetics and Anti-Drug Antibody
Frontage Laboratories
11.2021 - 11.2022
Microbiologist II - Virology and Serology
Pennsylvania Department of Health
05.2020 - 11.2021
Scientist - Cellular and Molecular Biology
Eurofins
02.2017 - 05.2020
Bachelor of Arts - German Language, Culture, Literature, And History
Millersville University of Pennsylvania
Bachelor of Science in Biology -
Millersville University
Chemistry Minor
Millersville University of Pennsylvania
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