cGMP Professional

Contact

609-***-**** (Mobile)

*************@******.*** (email)

Languages

English (Full Professional) Tamil (Limited Working)

Sanjev Rajaram

Greater New York City Area

Summary

I completed my undergraduate degree at Rowan University where I was enrolled in the Bachelor of Science program graduating with a degree in Biological Sciences, possessing a strong foundation in chemistry; my coursework includes Biochemistry and Quantitative Analysis.

Experience:

I am knowledgeable with analytical instrumentation, such as HPLC, UPLC, UV/VIS, Karl Fischer titrators and USP Dissolution units. I have experience in the pharmaceutical industry and I am well versed in cGMP in regards to protocols, documentation and testing.

Work Experience

Solgar/Nature’s Bounty Co.

Chemist I

May 2019- September 2019 ( 5 Months)

* Performed Weight variation on tablets, capsules and soft gels

* Performed disintegration testing on tablets and capsules

* Performed dissolution testing on tablets

* Prepared various solutions including acetate buffers

* Performed gluten positive testing on tablets and capsules

* Performed documentation which was up to par with cGMP standards

* Kept notebooks and paperwork in compliance with cGDP standards

* OOS testing

* Vetted notebooks and documents

Hemispherx Biopharma, Inc.

Chemist

January 2019 - April 2019 (4 months)

* Performed TOC and conductivity testing for purified water

* prepared standards in the parts per billion concentration (ppb)

* collected Purified Water using proper sanitation methods

* maintained laboratory notebooks for quality control and analytical r&d testing in compliance with regulations

Integra LifeSciences

Analytical Chemist

October 2018 - December 2018 (3 months) Plainsboro, NJ

• Utilize working knowledge of basic laboratory techniques necessary for working at the bench to analyze several products

• Understand the Product Development Process as it pertains to Research & Development functions dealing with medical device categories.

• Understand and apply SOP/GLP protocols with regards to data generation, operation, standardization, maintenance, and requirements

• Maintained laboratory notebooks for Quality Control and Analytical R&D testing in compliance with regulations

Lupin Pharmaceuticals

QC Chemist

September 2017 - October 2018 Somerset, New Jersey

Light Scattering (e.g. Malvern), density, water determination by KF, and tests according

•Perform routine tests of finished product and stability samples including dissolution, assays,chromatographic purity, content uniformity using UV, HPLC, and particle size distribution

to the in-house monographs and USP in a regulated laboratory environment.

•Evaluated test results and decided acceptability of the samples based on the test results.

•Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep

proper documentation in compliance with SOPs.

•Compliance with cGMP.

•Design and develop test methods, perform experimental tests and evaluate performances.

•Write test methods, method validation protocols and reports.

•Establish test specifications and communicate with internal and external customers.

•Analyze and interpret results in written and oral format.

•Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety

Practices.

AustarPharma, LLC

Analytical Laboratory Technician

May 2016 - August 2017 (1 year 4 months) Edison, New Jersey

•Support Sr.Formulation Scientists and Sr. Analytical Research & Development Chemists for research, product development, troubleshooting, and testing.

•Quality Control and production support - Formulation and Analytical Research & Development work in collaboration with QC and production.

•Conduct sample and solution prep, product sample testing and analysis, and report results.

•Assist with calibration of equipment and instruments such as HPLC and column heaters

•Participated in on-site third party regulator inspections

•Participated in FDA on-site inspections

•Testing performed includes bulk & tapped density, USP dissolution testing, water (moisture) determination by Karl Fischer titration and sieve analysis

Education

Rutgers University - Graduate School Newark

Continuing Studies · (2016 - 2016)

Rowan University

Bachelor of Science (B.Sc.), Biological Sciences · (2010 - 2014)

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