Megha Shrestha
Hackensack,NJ
Summary
Passionate and Innovative R&D Scientist with ~2 years of experience in product development, disinfectant efficacy testing, and cross-functional R&D execution within regulated healthcare environments. Proven ability to support end-to-end product lifecycle activities and committed to driving impactful research outcomes and contributing to scientific advancements.
Overview
3
3
years of professional experience
Work History
R&D Scientist
PDI Inc.
Woodcliff Lake, NJ
08.2024 - Current
- Contributed to development and optimization of intermediate-regulated disinfectant products, including nonwoven-based systems and liquid formulations, supporting formulation refinement, stability studies, and performance validation to ensure product quality, safety, and efficacy.
- Developed and implemented microbiological testing methods for high-risk organisms including C. difficile and C. auris, leveraging in-vitro and cell-based approaches to support innovation, product claims, and next-generation antimicrobial solutions. Supported evaluation of novel chemistries aimed at improving product performance and expanding the disinfectant portfolio.
- Strong experience in product performance evaluation, validation testing, stability studies, and technical data analysis to support regulatory submissions, efficacy claims, and business decision-making. Ensured data integrity, accuracy, and consistency across multiple research and development programs.
- Collaborated extensively with cross-functional teams including R&D, Quality, Regulatory Affairs, Manufacturing, Marketing, and external laboratory partners to ensure seamless execution of projects, compliance with standards, and timely delivery of milestones.
- Supported advancement of internal testing capabilities by optimizing workflows and reducing reliance on external laboratories, improving efficiency, turnaround time, and technical independence of in-house R&D operations.
- Actively contributed to innovation initiatives, including academic collaborations and IP-supporting work, contributing to advancement of novel disinfectant technologies and future product pipeline development.
- Experienced in quality systems and compliance activities including OOS investigations, MOC's, non-conformance handling, CAPA support, product improvement investigations, and audit readiness (including FDA inspections), with strong adherence to GMP, SOPs, and laboratory safety standards.
- Demonstrated consistent high-performance delivery on key initiatives on projects, ensuring technical rigor, cross-functional alignment, and successful execution under fast-paced timelines.
Analyst AD/QC, (Temp/PT)
i3 Pharmaceuticals, LLC
Warminster, PA
06.2024 - 08.2024
- Supported analytical and microbiological testing for R&D samples, raw materials, and finished products across development and stability programs, ensuring compliance with SOPs, cGLP, and cGMP standards. Contributed to quantitative and qualitative analysis using compendial methods to support product quality, performance, and lifecycle decisions.
- Assisted in microbiological method verification and review aligned with USP standards including antimicrobial effectiveness, microbial enumeration, sterility, and endotoxin testing. Supported method development, validation, and transfer activities, ensuring robust and compliant testing workflows.
- Participated in OOS investigations through structured data collection and analysis, contributing to root cause evaluation and product quality resolution. Supported laboratory operations including equipment maintenance, calibration, and documentation to maintain audit readiness.
- Assisted in analytical testing using HPLC (Agilent systems) and Waters Empower 3 for evaluation of drug substances, excipients, and product formulations, ensuring accurate and reliable data for R&D decision-making.
Research Assistant
Phutung Research Institute
Nepal
03.2023 - 09.2023
- Supported development of a low-cost, real-time water quality assessment prototype for detecting bacterial contamination in drinking water, contributing to innovation in accessible hygiene and safe water solutions for low-resource settings aligned with public health protection goals.
- Conducted comprehensive physical, chemical and microbiological tests to assess water safety and support method development for rapid detection technologies.
- Contributed to development and validation of real-time bacterial detection approaches using fluorescence and spectroscopic techniques, supporting advancement of rapid hygiene monitoring and contamination detection systems.
- Participated in chlorination and water safety assessment projects, using standardized colorimetric methods (DPD-based analysis) to evaluate disinfectant levels and support safe drinking water initiatives.
- Collaborated with government stakeholders on water quality monitoring and research-driven policy support, contributing to public health improvement, environmental safety, and community hygiene initiatives.
Public Health Intern
District Public Health Office
Nepal
01.2023 - 03.2023
- Conducted diagnostic and microbiological testing of infectious disease samples using validated laboratory methods and aseptic techniques, supporting accurate pathogen detection and contributing to improved health protection and hygiene outcomes.
- Performed analysis of human and environmental samples for pathogens of public health significance, generating reliable data to support infection control, outbreak response, and risk mitigation aligned with public health and hygiene improvement goals.
- Supported field and laboratory-based sample processing, epidemiological data collection, and community health initiatives, contributing to disease surveillance, prevention strategies, and public awareness efforts aimed at reducing transmission and improving community health outcomes.
Education
Master of Science - Environment and Public Health Microbiology
Central Department of Microbiology, Tribhuvan University
Kirtipur, Nepal01-2023
Bachelor of Science - Microbiology
St. Xaviers College
Kathmandu, Nepal06-2019
Skills
- EPA
- QC
- FDA
- Laboratory Equipment
- Attention to detail
- Problem-solving
- Time management
- Oral and written communication
- Commercial Awareness
- Collaborator
- Partnership Building
- Process Improvement
Timeline
R&D Scientist
PDI Inc.
08.2024 - Current
Analyst AD/QC, (Temp/PT)
i3 Pharmaceuticals, LLC
06.2024 - 08.2024
Research Assistant
Phutung Research Institute
03.2023 - 09.2023
Public Health Intern
District Public Health Office
01.2023 - 03.2023
Bachelor of Science - Microbiology
St. Xaviers College
Master of Science - Environment and Public Health Microbiology
Central Department of Microbiology, Tribhuvan University