Summary
Overview
Work History
Education
Skills
Degree
Personal Information
Publications
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Roli Jain

Cumming,USA

Summary

Results-driven Senior Scientist/Lead with a robust 15-year background in the pharmaceutical and biotech industry, having contributed significantly to Quality Assurance (QA), Analytical Method Development and Validations, Technology Transfers, Process Development, CMC, and Regulatory Affairs. QA Excellence: Championed a culture of quality throughout the organization by conducting comprehensive QA audits, generating detailed reports, and providing critical support in risk assessment. Demonstrated proficiency in navigating regulatory landscapes, contributing to successful IND and NDA filings, and maintaining strict compliance with GMP environments and FDA/ICH guidelines. Analytical Method Development and Validations: Established phase-appropriate analytical methods, specifications, and reports for API and DP. Managed and oversaw CMC analytics, including method development, validation, transfer, and release testing in CRO/CMO settings. Provided vital analytical support to DS manufacturing in GMP environments. Data Analysis and Compliance: Conducted meticulous reviews of analytical, QC, and stability data to ensure accuracy, completeness, and regulatory compliance. Expertise includes thorough scrutiny of notebooks, logbooks, metadata (chromatography and spectroscopy), stability data, QC routine data, method development, validation, and tech transfer data. Analytical Techniques and Instrumentation: Demonstrated hands-on experience with a diverse array of analytical techniques and instruments, such as HPLC, UV, IR, KF, XRD, particle size analyzer, and Dissolution. Ensured precision and accuracy through effective calibrations. Subject Matter Expertise (SME): Specialized in Dissolution and UV spectroscopy, contributing to the successful development of small molecular therapeutics and biopharmaceutical programs. Remote Work Proficiency: Adept at working remotely, leveraging smart lab technologies, and utilizing central document management software like LIMS, Veeva Vault, RIM, HLEE, ELN Click Once, REDS, and Spotfire. Workflow Optimization: Executed workflow processes supporting data acquisition integration, document routing, and outcomes documentation for qualification activities. Provided valuable administrative support within document management systems. Data Analysis and Insights: Expert in analyzing historical or ongoing campaign data using software like Excel, JMP, Power BI, and Tableau. Transformed data into actionable insights, contributing to continuous product development.

Overview

19
19
years of professional experience

Work History

Scientist AS (Attribute Science commercial)

Amgen
01.2024 - Current
  • Reviewed analytical data from HPLC and other analytical technique for developmental, clinical, and commercial products to ensure accuracy and compliance with GxP standards.
  • Managed stability studies, including creating and reviewing studies in LIMS, and analyzed sample test results.
  • Prepared comprehensive stability summaries and reports for regulatory submissions, ensuring compliance with IND and NDA requirements.
  • Utilized advanced statistical techniques to identify trends and provide actionable insights for decision-making.
  • Entered and tracked deviations and investigations using TrackWise.
  • Proficient in using LIMS and HPLC for data review and analysis.

Quality Auditor - Scientific

Merck
09.2022 - 01.2024
  • Conducted audits of regulatory filings, ensuring strict compliance with GxP and FDA requirements.
  • Independently reviewed and approved stability data, protocols, and reports for developmental and commercial products.
  • Collaborated with cross-functional teams to address quality issues and improve compliance processes.
  • Utilized tools like Veeva Vault, REDS, and RIM for document management and audit oversight.
  • Conducted audits for Biological License Application (BLA) sections, ensuring adherence to regulatory standards.
  • Represented the Global Manufacturing and Quality (GMPQ) team on inter-departmental and cross-functional teams.
  • Coordinated extensively with the Chemistry, Manufacturing, and Controls (CMC) department.

Scientist AS (Attribute Science commercial)

Amgen
11.2020 - 09.2022
  • Company Overview: Aqueor Technologies
  • Performed Test-A-Batch (GAP) assessments to analyze potential gaps and develop mitigations for the tech transfer of analytical methods across cross-functional sites.
  • Review HPLC, GC and other DS and DP data come from the different site for approval.
  • Reviewed analytical methods and validation documents, ensuring all critical attributes are aligned and standardized across sites.
  • Conducted risk assessments for elemental impurities and residual solvents to identify potential quality risks and implement strategies to mitigate their impact on product quality and safety.
  • Analyzed and interpreted analytical data to provide critical support for ongoing investigations, enhancing decision-making processes.
  • Managed lifecycle changes and post-approval process improvements, contributing to the enhancement of analytical methods and reduction of variability in product quality.
  • Successfully handled multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
  • Part of dissolution Out-of-Specification (OOS) investigations, verified and statistically analyzed data, identified critical factors affecting method performance, and defined Corrective and Preventive Actions (CAPA).
  • Assessed impurities data for Drug Substance (DS) and Drug Substance Intermediate (DSI), contributing to designing and analyzing an OFAT-QbD approach to identify gaps and mitigations in the DSI manufacturing process.
  • Conducted root cause analysis and resolved deviations or out-of-specification results, implementing corrective actions to maintain product quality and consistency.
  • Supported the late stage of the product development cycle by providing data for filing market applications, contributing to successful regulatory submissions.
  • Supported project teams by providing GxP compliance advice and guidance to stakeholders, fostering continuous quality improvement and effective quality controls.
  • Managed, uploaded, revised, and archived documents using SharePoint and CDOCS or viva vault ensuring accurate document control.
  • Worked as a data verifier and handled tools like LIMS, HLEE, RIM, and CDOCS portals for efficient data management.
  • Aqueor Technologies

Quality control/ Assurance Associate

Catalyst Nutraceuticals
08.2019 - 04.2020
  • Provided extensive analytical support for manufacturing safe and effective health supplements.
  • Reviewed 8-10 analytical reports, focusing on elemental impurities and microbiological aspects.
  • Integral part of the raw materials vendor qualification process, coordinating with vendors and making decisions based on manufacturing site data.
  • Led a team of lab techs and supervisors, establishing general guidance in GLP and GMP processes.
  • Approved all analytical and QC reports.
  • Proactively identified, analyzed, and leveraged quality indicators and data to address potential trends and risks.
  • Conducted risk-based QA assessments and supported the implementation of associated risk mitigation strategies.
  • Developed cost-effective methods for botanical markers using TLC.
  • Prepared and reviewed SOPs, work instructions, and developed flow charts for facility operations.
  • Conducted internal audits and played a critical role in ASI and organic certification audits.
  • Conducted internal GMP audits periodically.

Quality control Associate

ALCON
04.2019 - 08.2019
  • Conducted analysis and data collection for QC analytical testing of raw materials, in-process, final products, and packing components.
  • Ensured compliance with cGMP, FDA regulations, and corporate Quality policies, following approved SOPs, methods, and procedures.
  • Performed routine stability testing to assess product quality over time.
  • Properly handled various analytical equipment, including GC, HPLC, UV-Vis, FTIR, titrations, USP Monograph testing, viscometer, osmometer, and particle size analyzer.
  • Utilized LIMS as a data-sharing tool following GLP standards.
  • Participated in training activities to maintain and improve laboratory skill sets and practices.
  • Actively worked in a team environment to enhance productivity.

Research Associate Volunteer

Philadelphia College of Osteopathic Medicine
11.2016 - 11.2017
  • Worked as a volunteer research associate under the supervision of Dr. Vicky Mody School of Pharmacy, Georgia Campus.
  • Developed a method to quantitate the APAP–CYS concentration in liver plasma by LC-MS and HPLC.

Senior Research Scientist

Promod Research Center
03.2007 - 04.2013
  • Designed experiments for method development, validation, and technology transfer, primarily for ophthalmic drug products.
  • Averaged 1-2 method developments and validations in 1.5 months, encompassing protocol approval, procurement, planning, experimentation, data analysis, and validation report preparation.
  • Prepared and reviewed method development, validation, transfer technology, and stability protocols.
  • Reviewed Drug Master File, conducted pre-formulation to optimize drug-excipient interactions.
  • Conducted routine comprehensive testing, stability testing, and stability trend analysis, covering Assay, Related Substance, Identifications, Limit tests, and other physical metrics.
  • Collaborated with the quality and regulatory affairs team to meet technical document requirements for successful product submissions.
  • Actively contributed to the filing of Abbreviated New Drug Application (ANDA) submissions.
  • Developed a phase-appropriate analytical control strategy using various methods.
  • Established specifications for key intermediates and Drug Substance (DS).
  • Worked with formulation scientists to establish appropriate stability programs.
  • Authored standard analytical testing methods, IPC methods, and specifications for GMP release testing.
  • Adopted new technologies, platforms, and instruments for organizational growth.
  • Led a group of scientists, providing guidance in dissolution method development for small molecules.
  • Collaborated with the procurement team for method development inventory.
  • Supervised and guided a junior scientist for troubleshooting and method development.
  • Drafted, revised, and reviewed standard test and operating procedures, as well as instrument calibration reports.
  • Resolved market queries for existing products.
  • Conducted stability and stress studies and finalized Certificates of Analysis (COA).

Education

Diploma - Full stack Data science

Jigsaw Academy

Post Graduate Diploma - Pharmaceutical Drug Regulatory Affairs

Jamia Hamdard University
01.2011

Ph.D. - Kinetics Study Of Delayed Drug Release formulations

Dr. Hari Singh Gaur University
07.2010

Masters - Analytical Chemistry

Dr. Hari Singh Gour University
01.2004

Bachelor of Science - Botany, Zoology, and Chemistry

Govt. P.G. College
01.2002

Skills

  • GxP Compliance & Regulatory Submissions
  • Stability Studies & Data Management
  • Analytical Techniques: HPLC, Dissolution, UV, IR, KF
  • Laboratory Information Management Systems (LIMS)
  • Investigation Software (TrackWise)
  • Statistical Data Analysis & Reporting
  • Document Management: Veeva Vault, RIM, SharePoint
  • Cross-Functional Team Collaboration
  • Project Planning & Coordination

Degree

Ph.D. Analytical Science

Personal Information

Title: Senior Scientist/Lead

Publications

  • R. Jain, A. Pandey, S.S. Pandey, Mechanism of Dissolution of delayed Release form of Diclofenac sodium, Bulgarian Journal of Chemical Education, 18, E131-E138, 2009
  • N. Nema, R. Jain, A. Pandey, In-vitro release kinetic study of domperidone by using water-soluble carrier polyvinylpyrrolidone, NATL ACAD SCIENCES INDIA, 81, 289-294
  • Dare M, Jain R, Pandey A, Method Validation for Stability Indicating Method of Related Substance in Active Pharmaceutical Ingredients Dabigatran Etexilate Mesylate by Reverse Phase Chromatography, J Chromatography Sep Tech, 6, 263, 10.4172/2157-7064.1000263
  • Sandeep Kumar Shukla, Roli Jain, Archana Pandey, Nanosuspension formulation to improve the dissolution rate of Clonazepam, International Journal of Advanced Research, 3, 4, 588-591, 2015
  • Jain R, Panday A, A Review of Kinetics of Nanoparticulated Delayed-Release Formulations, J Nanomed Nanotechnol, 6, 304, 10.4172/2157-7439.1000304
  • Jain R, Sukla SK, Nema N, Panday A, Drug Nano-particle: A Release Kinetics, J Nanomed Nanotechnol, 6, 317, 10.4172/2157-7439.1000317
  • Dr. Roli Jain, A systemic review: Structural Mechanism of SARA-CoV and Promising Preventive Cure by Phytochemicals, Int J Immunol Immunother, 2020, 7, 1, 051
  • Dr. Roli Jain, Dr. Archana Panday, COVID-19: A Cure and Preventive Options, Int J Immunology and Immunotherapy, 2020-06-29
  • R Jain, S Sukla, A Panday, Kinetic modeling and release behavior of PLGA-loaded nanoparticle of anti-malarial drug using dialysis membrane, Nanomed. Nanotechnol. J, 2019
  • Sandeep Kumar Shukla, Roli Jain, Archna Pandey, Nanosuspension formulation to improve the dissolution rate of Clonazepam, International Journal of Advanced Research, 3, 4, 588-591, 2015
  • Nema, N, Jain, R, Pandey, A, In-vitro release kinetic study of domperidon by using water soluble carrier polyvinylpyrrolidone, United States Environmental Protection Agency, 2011, 81A, 289-294
  • Roli Jain, Green Synthesis of Zinc Oxide Nanomaterial, Spectrum of Emerging Sciences, 2, 1, 36-44, 2022
  • Ahmed, Hilal, Irshad Ahmed, Tousief, Jain, Roli, Rathore, Jyoti, Natarajan, Shanthi, Rawat, Reena, Jain, Bhawana, Chapter 8 Anti-cancerous and anti-HIV activity of medicinal plants, Phytochemicals in Medicinal Plants: Biodiversity, Bioactivity and Drug Discovery, Charu Arora, Dakeshwar Kumar Verma, Jeenat Aslam, Pramod Kumar Mahish, De Gruyter, 2023, 185-204
  • Roli Jain, Daniel Amoako Darko, Bhawana Jain, Ruchi Sharma, Reena Rawat, Carbon Allotropes: Nanostructured Anti-Corrosive Materials, Walter de Gruyter GmbH & Co KG, 241

Timeline

Scientist AS (Attribute Science commercial)

Amgen
01.2024 - Current

Quality Auditor - Scientific

Merck
09.2022 - 01.2024

Scientist AS (Attribute Science commercial)

Amgen
11.2020 - 09.2022

Quality control/ Assurance Associate

Catalyst Nutraceuticals
08.2019 - 04.2020

Quality control Associate

ALCON
04.2019 - 08.2019

Research Associate Volunteer

Philadelphia College of Osteopathic Medicine
11.2016 - 11.2017

Senior Research Scientist

Promod Research Center
03.2007 - 04.2013

Post Graduate Diploma - Pharmaceutical Drug Regulatory Affairs

Jamia Hamdard University

Ph.D. - Kinetics Study Of Delayed Drug Release formulations

Dr. Hari Singh Gaur University

Masters - Analytical Chemistry

Dr. Hari Singh Gour University

Bachelor of Science - Botany, Zoology, and Chemistry

Govt. P.G. College

Diploma - Full stack Data science

Jigsaw Academy

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