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
20
20
years of professional experience
3
3
Certifications
Work History
Process Development and Validation Scientist
Alora pharmaceuticals - Osmotica Pharmaceuticals
Marietta
03.2022 - 04.2025
- 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
11.2020 - 03.2022
- 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
02.2020 - 05.2020
- 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
02.2016 - 06.2019
- 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
02.2005 - 06.2007
- 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, India07-2004
Bachelor's of Pharmacy -
H.N.B.G. University
Srinagar, Uttarakhand, India01-2000
Skills
- Process scale-up
- Product development
- Chromatographic methods
- Accelerated solvent extraction
- Statistical analysis techniques
- Regulatory submissions
- Technical writing
- Project management
- Cross-functional collaboration
- GMP compliance
- Attention to detail
- Time management
Certification
Minitab
Languages
English
Professional
Hindi
Professional
Work Preference
Job Search Status
Open to workWork Type
Full TimeSalary Range
$45000/yr - $200000/yrTimeline
Process Development and Validation Scientist
Alora pharmaceuticals - Osmotica Pharmaceuticals
03.2022 - 04.2025
Formulation Chemist
Norax Supplements
11.2020 - 03.2022
Associate Scientist
Alcami Pharmaceutical
02.2020 - 05.2020
Junior Analytical Scientist(c)
Kimberly Clark Corporation
02.2016 - 06.2019
Formulation development scientist
Dabur Research Foundation
02.2005 - 06.2007
Masters of Pharmacy - Pharmaceutics
University of Pune
Bachelor's of Pharmacy -
H.N.B.G. University