Shivani Singh
Parsippany,NJ
Summary
A Chemistry enthusiast with 9+ years of experience working in academics and pharmaceutical industry, strong analytical background, and extensive working knowledge of instrumental analysis. Dynamic individual with hands-on experience in UPLC-MS systems and knowledge of various regulatory requirements. Brings strong problem-solving skills and proactive approach to new tasks. Committed to making meaningful contributions and advancing organizational goals.
Overview
7
7
years of professional experience
Work History
Scientist III
Parexel
09.2024 - Current
- Manage laboratory resources and protocols, ensuring compliance with safety standards.
- Ensure optimal performance of UPLC-MS-CAD analysis weekly and each plate analysis.
- Operate and maintain open access LC-MS instruments. Monitor instrument performance, troubleshoot minor issues and raise major issues to third-party service engineers and/or management.
- Consistently deliver high quality and fully compliant results. Interact with diverse customer base daily.
- Strong working knowledge of MassLynx and Versidian softwares.
- Timely and accurately document experiments in SIGNALS electronic notebook.
Scientist SMARD
E Team. Inc
07.2023 - 09.2024
- Perform analytical lab work to support product development.
- Conduct analysis of drug substances and drug products following SOPs and cGMPs.
- Extensive hands-on experience with proficiency of analytical instruments such as GC, HPLC, Mass and KF Titration (Volumetric, Coulometric and Oven).
- Accurately and timely document experiments and results in ELN and perform review.
- Strong working knowledge of EMPOWER and Chromeleon chromatographic data analysis softwares.
- Good understanding of GLP or GMP compliance requirements and ALCOA documentation principles.
- Troubleshooting basic testing and analytical instruments.
- Follow written procedures and analytical laboratory practices to ensure quality & compliance.
- Carry out all assignments to the company standards of efficiency, innovation, accuracy and safety.
Adjunct Professor of Chemistry
Natural Sciences Department, Middlesex County College
01.2018 - 12.2022
- Provide academic guidance and direction to more than 200 students in the fields of applied chemistry, organic chemistry, and general chemistry
- Provide mentorship to 25+ undergraduate research students
- Co-led supervision team to ensure syllabus adherence and satisfactory course completion by adjunct faculty and other department initiatives as per internal policies and procedures
- Represent the Department on the council for adjunct faculty development
Education
Regulatory Affairs Certificate Program - Dual Regulatory Certificate – Pharmaceuticals & Medical Devices
RAPS
02.2023
Advanced Graduate Degree MPhil - Applied Chemistry
IIT ISM
Dhanbad, India05.2009
Masters of Science (M.Sc.) - Chemistry
NIT
Jalandhar India05.2008
Bachelor of Science (B.Sc.) - Physics, Chemistry and Mathematics
Panjab University
Chandigarh, India04.2006
Skills
- Analytical Chemistry/Testing
- Gas Chromatography (GC)
- HPLC, UPLC-MS-CAD
- KF Titration (Volumetric, Oven)
- Mass Spectrometry
- EMPOWER, Chromeleon, MassLynx, Verscidian Softwares
- ELN, SIGNAL
- Quality Control (QC)
- Quality Assurance (QA)
- GxPs / GMP/ GLP/ GDP
- Electronic Document Management System (EDMS)
- Laboratory Information Management System (LIMS)
Resident Status
U.S. Citizen
Timeline
Scientist III
Parexel
09.2024 - Current
Scientist SMARD
E Team. Inc
07.2023 - 09.2024
Adjunct Professor of Chemistry
Natural Sciences Department, Middlesex County College
01.2018 - 12.2022
Regulatory Affairs Certificate Program - Dual Regulatory Certificate – Pharmaceuticals & Medical Devices
RAPS
Advanced Graduate Degree MPhil - Applied Chemistry
IIT ISM
Masters of Science (M.Sc.) - Chemistry
NIT
Bachelor of Science (B.Sc.) - Physics, Chemistry and Mathematics
Panjab University
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