Research Chemist

KOMAL PATEL

***** ******* ***** **.***#***, Raleigh, NC, 27614. 732-***-****.(mobile). *****.*******@*****.***

Enthusiastic and highly motivated chemist with 9 years experience in various modern analytical instruments, seeking a position in Pharmaceutical environment.

SUMMARY OF QUALIFICATION

• Good theoretical and practical knowledge of the various instruments describe below

• Very enthusiastic and motivated in learning new instrumentation and methods

• Ambitious and hard working with commitment to excellence, highly attentive to detail

• Friendly with positive attitude and an effective communicator both written and verbal

TECHNICAL SKILLS

Instruments:

• Dissolution apparatus I, II and III UV-Visible Spectrophotometer

• High Performance Liquid Chromatography Karl Fisher – Titrator

• Disintegration Apparatus Particle Size Analyzer

• pH-meter

Computer: Microsoft Office, Empower, UV-Chem Station, Millennium, and Total Chrome.

Techniques:

• Liquid Chromatography (LC) Ultra Violet Spectroscopy (UV)

• Titration

• Dissolution

PROFESSIONAL EXPERIENCE

Sandoz, Wilson, NC May ‘08 – August ‘09

Research Chemist -II

• Responsibility entailed; Assay and Dissolution Tests Method Development and Method Validation.

• Analyzed Finished products, Intermediate products, and Stability products for Drug Release, Assay Content, Content Uniformity, HPLC-Identification, Related Compounds, Blend Uniformity, UV-Visible Identification, Particle Size Determination.

• Audited and Peer Reviewed analytical documentation.

• Conducted Performance Verification, Preventative Maintenance and Performance Qualification on Waters Alliance systems and Dissolution bath.

• Obtained good working knowledge of cGMP, GLP, ICH, and OSHA guidelines and regulations.

• Experienced in development of protocols and SOPs.

• Performed Method transfer from Sandoz, USA to Sandoz, India –Cleaning Validation, Particle Size, Dissolution, and Assay.

• Monitored yearly inventory of control drugs.

Actavis, Inc., Elizabeth, NJ Jul ‘06 – May 08.

Associate Scientist -II

• Performed automated dissolution testing on Early Development Sample using USP Apparatus I & II method, (Agilent HP8453 online UV with the Chemstation software).

• Acquired excellent understanding of HPLC instrumentation (UV and PDA detectors), data interpretation and trouble shooting. Routinely performed HPLC analysis on daily basis and also worked on development, validation and R&D support testing.

• Performed Calibration, Performance Verification, Preventative Maintanance and Performance Qualification of HPLC systems and Dissolution baths.

• Gained through knowledge of in-process, finished product, stability sample tests like impurity, assay, CU, BU, water determination and cleaning verification.

• Experienced in developing methods for Assay and Dissolution tests.

• Assisted in the review and writing of protocols and SOPs.

• Trained other analysts on calibration, use of equipments and testing methods.

• Maintained additional responsibility of being Controlled Drug Substance Coordinator for a year.

Sandoz, Inc., Dayton, NJ (Generic Division of Novartis) Oct ‘99 – Jun‘06

Research Chemist I

• Performed manual and automated dissolution testing on R&D, stability, process validation and in-process samples using USP Apparatus I, II, and III according to in-house and USP testing procedures.

• Developed and validated dissolution methods using UV-Vis spectrophotometer.

• Performed analysis on dissolution samples using Water 2487 and Agilent 1100 HPLC systems, and Totalchrom data acquisition for data processing.

• Performed laboratory maintenance and calibration of pH meters, balances, spectrophotometers, Karl Fisher titrators and dissolution apparatus.

• Experienced with the operation and maintenance of Distek 5100 and 6100 bathless dissolution apparatus, Distek 4300 and Vankel VK8000 auto samplers, as well as the Agilent HP8453 online UV using the Chemstation software.

• Developed and Validated USP III calibration procedures.

• Followed cGMP and cGLP Sandoz best practices.

• Earned various Sandoz Safety awards, such as Galaxy.

EDUCATION

• B.S. in Microbiology, India

PROFESSIONAL ACCREDITATION

• USP Fundamentals of Dissolution – US Pharmacopoeia, NJ, 2007

• Dissolution - Varian Corp., 2004

• Essential Chemistry Concepts - Middlesex County College, NJ, 2004

• Windows 98/Excel, Word, Power Point – Comat Training Center, NJ, 2000

• Medical Laboratory Technology – NHA, Newark, NJ, 1995

• Classroom: cGMP, SOPs, IT, theory of dissolution and HPLC, code of conduct, safety

• Hands-On: Operation and calibration of various analytical instrumentation

REFERENCES: Available upon request

Contact this candidate