CHARU KAMAL YERNENI
COATESVILLE,USA
Summary
Senior Scientist II specializing in chromatographic techniques with a successful track record at Flamma USA. Demonstrated leadership in cross-functional teams to optimize analytical processes and advance product development. Strong analytical skills and mentorship capabilities have resulted in enhanced project outcomes and adherence to regulatory standards.
Overview
20
20
years of professional experience
Work History
Senior Scientist II
Flamma USA
Malvern, USA
03.2022 - Current
- Managed multiple projects simultaneously, mentored chemists, and troubleshot technical challenges to support API process development.
- Providing Analytical subject matter expertise, coordinating method development and validation activities to support process development.
- Collaborated with internal and external teams, particularly the process development team, to facilitate problem-solving and knowledge sharing.
- Implemented solutions that enhanced efficiency, productivity, and quality across analytical processes.
- Critically analyze all analytical data and provide inputs/advice that would drive the entire cycle of analytical aspects of product management from development, validation to specification setting etc.
- Expertise in analysis of API samples at various stages of campaign like IPCs, Intermediates and finished products.
Senior Scientist II
i3 Pharmaceuticals, LLC
Warminster, USA
10.2021 - 02.2022
- Led research projects to develop pharmaceutical formulations and delivery systems.
- Collaborated with cross-functional teams to optimize product development processes.
- Analyzed experimental data to ensure compliance with regulatory standards.
- Led scientific and technical initiatives for junior chemists, conducted investigations, documented analytical experiments, and wrote reports, protocols, and SOPs.
Senior Scientist I
i3 Pharmaceuticals, LLC
Warminster, USA
09.2020 - 09.2021
Research Scientist III
i3 Pharmaceuticals, LLC
Warminster, USA
09.2018 - 08.2020
- Conducted experiments to develop new pharmaceutical compounds and formulations.
- Analyzed data to evaluate the effectiveness of drug candidates in clinical trials.
- Conducted stability and R&D sample testing using laboratory equipment including dissolution apparatus, UV/Vis spectrophotometer, HPLC, GC, FTIR, and wet chemistry techniques.
- Developed and validated methods for testing raw materials and finished products.
- Collaborated with cross-functional teams to ensure project alignment and progress.
Senior Analytical R & D Chemist/ Analytical Scientist III
Tris Pharma, Inc.
Monmouth Junction, USA
10.2014 - 07.2018
- Managed over 10 NDA and ANDA projects within three years, ensuring adherence to regulatory requirements and timelines.
- Conducted analytical activities in pharmaceutical product development, including method development, evaluation, transfers, and stability studies, contributing to successful product formulations.
- Ensured detailed analysis of drug product components, emphasizing active ingredients, preservatives, and impurities.
- Understood and applied USP, FDA, and ICH guidelines for analytical methods and laboratory practices.
- Handled and tested various formulations, including extended-release oral suspensions and tablets of small molecules.
- Participated in the preparation of various product submissions, including ANDAs and NDAs.
- Engaged in multiple stages of product submission, ensuring compliance with cGMP regulations.
- Provided guidance to five newly hired and junior scientists.
Graduate Research and Teaching Assistant
Purdue
09.2008 - 08.2014
- Instructed undergraduate chemistry courses, enhancing students' understanding of core concepts and laboratory techniques.
- Assisted professors in preparing course materials and organizing lectures.
- Supported students by answering questions and providing academic resources.
- Coordinated study groups and facilitated collaborative learning sessions.
- Conducted research to develop UPLC column technology improving protein/peptide and glycoprotein bio separations.
Graduate Research and Teaching Assistant
Western Illinois
08.2006 - 05.2008
- Developed new glycan-based materials using novel synthetic methodologies and glycan analysis technologies such as Flash Chromatography, NMR, and HR-MS.
- Conducted extensive research in synthetic/organic and analytical chemistry, contributing to knowledge base in the field.
- Tutored freshman chemistry students to improve understanding and academic performance in course material.
Education
Ph.D. - Chemistry
Purdue University
West Lafayette, IN, USA05.2014
M.S. - Chemistry
Western Illinois University
Macomb, IL, USA05.2008
B.S. - Pharmaceutical Sciences
The Tamil Nadu Dr. MGR Medical University
Chennai, India05.2005
Skills
- Chromatography techniques
- Prep HPLC/Flash Chromatography
- Waters Empower
- Chromatographic analysis software
- LC/MS chromatography modes
- ESI -MS
- GC
- CE
- SDS-PAGE
- UV-Vis fluorescence spectrophotometry
- IR, FTIR spectrometer
- Data analysis Excel
- SEM
Awards
- Departmental Special Recognition Award for Superior Achievements in Chemistry, Western Illinois University, 04/08
- Competent Communicator, Toastmasters International, 11/11
- Applied Management Principles (Mini MBA), Purdue University, 05/12
- Artificial Intelligence in Pharma and Biotech, MIT Sloan School of Management, 04/24
Disclaimer
As far as I am concerned, the above-furnished details regarding me are true and correct to the best of my knowledge.
Judging Experience
Reviewer, Analytica Chimica Acta, Recognized reviewer status, 02/17
Academic Research
Novel Chromatographic Packing Method, 13/639, 165, 11/29/16, Prof. Mary Wirth, Purdue University, Cationic á-Cyclodextrin:Poly(ethylene glycol) Polyrotaxanes for siRNA Delivery, Molecular Pharmaceutics, 10.1021/mp300449t, Prof. David Thompson, Purdue University, New diruthenium (II,III) compounds bearing terminal olefin groups, 10.1016/j.ica.2012.11.008, Prof. Tong Ren, Purdue University, In-column bonded phase polymerization for improved packing uniformity, Journal of Separation Science, 10.1002/jssc.201601376, Prof. Mary Wirth, Purdue University, Oligomannan Synthesis Using Ionic Liquid Supported Glycosylation, Organic Letters, 10.1021/ol702743x, Prof. Ashish Pathak, Western Illinois University, Imidazolium Cation Supported Solution-Phase Assembly of Homolinear α(1→6)−Linked Octamannoside: An Efficient Alternate Approach for Oligosaccharide Synthesis, Journal of Organic Chemistry, 10.1021/jo901169u, Prof. Ashish Pathak, Western Illinois University
Timeline
Senior Scientist II
Flamma USA
03.2022 - Current
Senior Scientist II
i3 Pharmaceuticals, LLC
10.2021 - 02.2022
Senior Scientist I
i3 Pharmaceuticals, LLC
09.2020 - 09.2021
Research Scientist III
i3 Pharmaceuticals, LLC
09.2018 - 08.2020
Senior Analytical R & D Chemist/ Analytical Scientist III
Tris Pharma, Inc.
10.2014 - 07.2018
Graduate Research and Teaching Assistant
Purdue
09.2008 - 08.2014
Graduate Research and Teaching Assistant
Western Illinois
08.2006 - 05.2008
Ph.D. - Chemistry
Purdue University
M.S. - Chemistry
Western Illinois University
B.S. - Pharmaceutical Sciences
The Tamil Nadu Dr. MGR Medical University