Kunjan Gheewala
Monroe
Summary
To obtain a challenging position as Senior Chemist, Quality Control in the fragrance industry using technical skills.
A highly motivated energetic individual with outstanding technical and interpersonal skills in various types of instrumental analysis: HPLC, UV/VIS, dissolution, TLC FTIR, and Karl Fisher. Personal strengths include ability to work independently as well as in a team, strong analytical skills and attention to details. Proficient in cGMP and handled instrument troubleshooting. Extremely resourceful, team player, capable of rapidly learning and adapting to new systems and procedures.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Chemist
Symrise Inc.
Branchburg
01.2006 - Current
- Conducting wet analysis such as, Refractive Index, Specific Gravity (DMA 4500), Colorimetric LAB(Spectrophotometer CM-3500d), Encapsulation, Melting Point, Karl-fischer (Coulometric), Ash Content, and Gas Chromatography (Agilent 6890N),Chromeleon software, Optical Rotation, Particle size, Water Conductivity, Flash Point.
- Entered data using SAP R/3 software for accurate record-keeping.
- Also participated in QC process improvement by using Lean six sigma & 5S.
Associate Research Scientist (Analytical Development)
ALPHARMA PHARMACEUTICAL INC.
Elizabeth
01.2003 - 01.2006
- Conducted Assay, Related Compound, Content Uniformity, Blend Uniformity tests and dissolution.
- Created Release-Rate Profile of Pharmaceutical Drug Formulations, including immediate and especially sustained-release (Modified Release Products).
- In raw material, used USP monograph and followed Assay, Related Compound, Loss on drying, and TLC tests.
- Also, used Certificate of Analysis to prepare new specification for API.
- Assisted supervisor to review analytical data, and also trained chemists on how to set-up and run dissolution tests (manual or automated) and analyze samples by either HPLC or UV/VIS technique.
- Performed validation of dissolution test, cleaning validation, and analytical methods.
- All validation work of analytical methods required excellent knowledge of HPLC assay and UV assay technique in a strict cGMP environment.
- Tested solid oral dosage forms (tablets and capsules) according to in-house and/or USP methodology.
- Tested in-process, finished product, and stability samples to support new product ANDA/NDA submissions.
- Evaluated and transferred of new analytical methodology.
- Conducted and wrote laboratory investigations as well as, the review of analytical data.
- Conducted IQ/OQ/PQ of dissolution fraction collector (Distek).
- Performed calibration of dissolution bath, as well as the HPLC system (Waters).
- Also conducted the SOP assessment on Agilent (UV-Vis) chemstation.
- Worked with formulator to support the formulation process during the early development process.
- Worked on methods such as, Assay, Dissolution, and Related Compound (method development).
Scientist
Novartis Pharmaceutical
East Hanover
01.1999 - 01.2003
- Routinely performed various analytical tests such as Assay and Impurity using High Performance Liquid Chromatography (waters), Cumulative Release Rate, Thin Layer Chromatography, Gas Chromatography, Content Uniformity, and Water Analysis.
- Worked on Multidose Automated Dissolution workstation (Zymark), as well as TPW (Tablet processing workstation).
- Utilized wet Chemistry methods following USP monographs such as, Thin Layer Chromatography, Identification, Preparation of Test solutions, and Volumetric Solution.
- Working knowledge of Millennium 32 Data Acquisition System for chromatographic data evaluation and Q-dis LIMS system for data collection and reporting of results.
- Continuously updated knowledge of USP pronouncement and changes in SOP’s to ensure compliance.
- Performed cGMP laboratory inspections periodically.
- Maintained the temperature of all the refrigerators in the lab and regularly updated the standards in the incubator.
- Participated in the APR (Annual Product Review) project for the zero time point as well as stability on various products which required by the FDA.
- Trained the new Chemist in the group.
- Successfully achieved the “NJPQCA” certification.
Education
Bachelor of Science - Chemistry
Montclair State University
Upper Montclair, NJ01-1999
Skills
- Lotus 1-2-3
- Microsoft Word
- Excel
- Windows 98
- Windows NT
- Millennium 32 Data Acquisition
- Q-dis LIMS system
Certification
New Jersey Pharmaceutical Quality Control Association (NJPQCA)
Professional Development
- Millennium 32 Seminar
- Column Seminar
- HPLC Method and Validation Courses
Timeline
Chemist
Symrise Inc.
01.2006 - Current
Associate Research Scientist (Analytical Development)
ALPHARMA PHARMACEUTICAL INC.
01.2003 - 01.2006
Scientist
Novartis Pharmaceutical
01.1999 - 01.2003
Bachelor of Science - Chemistry
Montclair State University