Summary

Overview

Work History

Education

Skills

Certification

Languages

Work Preference

Timeline

Open To Work

VEENA NEGI

Johns Creek

Summary

Pharmaceutical scientist with nearly ten years of combined experience in formulation development, process validation, technology transfer, and regulatory compliance for pharmaceutical and nutraceutical products. Certified in advanced pharmacovigilance and drug regulatory affairs, with a proven track record of ensuring compliance with industry standards.

Overview

years of professional experience

Certifications

Work History

Process Development and Validation Scientist

Alora pharmaceuticals - Osmotica Pharmaceuticals

Marietta

2022.03 - 2025.04

Led process validation efforts for extended-release osmotic bilayer tablets, resulting in FDA approval and successful commercialization.
Conducted thorough validation studies for pharmaceutical products while ensuring documentation accuracy.
Managed comprehensive site transfer studies, encompassing pre-formulation trials and technical report submissions for regulatory compliance.
Developed protocols, batch records, and SOPs for API and excipient vendor qualification, supporting supply chain integrity.
Conducted hold and shipping studies verifying product stability and patient safety during distribution.
Reviewed GMP documentation, including environmental monitoring data, to ensure regulatory compliance.
Provided training on cGMP protocols while overseeing manufacturing processes to ensure adherence to quality standards.
Collaborated with diverse teams to achieve essential project milestones; supported R&D during product ideation phases.

Formulation Chemist

Norax Supplements

Cedar-town

2020.11 - 2022.03

Managed the end-to-end development of dietary supplements (tablets, capsules, powders, liquids) from initial concept to commercial launch.
Customized formulations per client specifications, conducted pilot-scale batches and internal sensory testing to secure customer approval.
Facilitated collaboration with cross-functional teams to optimize dosage forms and enhance production efficiency.

Associate Scientist

Alcami Pharmaceutical

Wilmington

2020.02 - 2020.05

Conducted precision analytical testing of parenteral formulations, ensuring accurate documentation in ELN10 to support regulatory compliance.
Executed laboratory protocols with high accuracy, contributing to a safe environment for sensitive pharmaceutical testing.
Conducted experiments to support drug formulation development at Alcami Pharmaceutical.
Collaborated with cross-functional teams to improve laboratory procedures and protocols.
Analyzed data from clinical trials to ensure compliance with regulatory standards.

Junior Analytical Scientist(c)

Kimberly Clark Corporation

Neenah

2016.02 - 2019.06

Performed quantitative analysis on various wipe formulations/finished products by chromatographic technique (HPLC, GC,) and provided test results/reports on an established deadline.
Conducted analytical method development and validation planning and documentation.
Conducted lotion add-on and lotion studies on facial and bath tissue products using accelerated solvent extraction (ASE) to optimize product quality.
Routine testing for stability studies, on several formulations and finished products.
Collaborated with research and development team across business units to enhance project outcomes.
Assisted in claim substantiation, audits, and comparative analysis to ensure regulatory compliance and product integrity.
Supported cost-saving initiatives on super absorbent polymers (SAP) through percent extractable analysis.
Independently completed projects, analyzed data, generated technical reports, and communicated with team and customers.

Formulation development scientist

Dabur Research Foundation

Delhi

2005.02 - 2007.06

Led formulation development, optimization, and commercialization of oral solid and liquid dosage forms for pharmaceuticals and nutraceuticals, enhancing product performance.
Conducted bench trials, feasibility runs, pilot trials, and stability studies for new and existing products, ensuring compliance with regulatory standards.
Reformulated existing products, enhancing quality and resolving stability issues to meet market demands.
Maintained lab notebook, generated master formula record (MFR), and created raw material record for new and existing products.

Education

Masters of Pharmacy - Pharmaceutics

University of Pune

Maharashtra, India

2004-07

Bachelor's of Pharmacy -

H.N.B.G. University

Srinagar, Uttarakhand, India

2000-01