CURRICULUM VITATE

Gopal samy Mobile: 646-***-****

****, ***** ***** *** *****: ac2efj@r.postjobfree.com

Brookhaven

Medford

New York- 11763

Present: Amneal Pharmaceuticals,R&D,Brookhaven, Newyork.

Career Objective

Looking for a Challenging position of the Pharmaceuticals- Analytical Research and Development

Educational Qualification : M.Sc., (Chemistry)

Area of Specialization : Pharmaceutical -Analytical R&D--- (Formulation)

Status : H1B visa Valid up to Year 2022

Summary:

Proficient in Analytical Method Development and Validation, Stability Studies and Routine analysis, Multimedia Dissolution time Profile, Release Analysis for ANDA and R&D & QC with excellent troubleshooting skills over HPLC consistently meeting timelines.( Oral solid Dosage,Injectables,Topical products Gel,Lotion,Cream)

9 + years’ Experience in Pharmaceuticals: Analytical Research &Development (AR&D)

Sun Pharma R&D (Erstwhile Ranbaxy) New Delhi-India.

From- October’ 2005 to November 2012 as a Sr. Reserach Chemist- Analytical R&D.

Lupin Pharma R&D (Erstwhile Novel Laboratories) Somerset, New Jersey.USA.

From- Nov’2012 to March 2013 as a Analytical Chemist- Analytical R&D.

Mankind Pharma, R&D. New Delhi -India.

From – Aug 2013 to Aug’ 2016 as a Sr, Research Scientist- ( Team Leader) Analytical R&D.

Ingenus Pharmaceuticals,LLC, Denville, New Jersey,USA.

From – Sep’2016 to June 2017 as a Sr. Scientist-- Analytical R&D .

Amneal Pharmaceuticals, Brookhaven,Newyork,USA

From – June2017 to till date as a Scientist-III-- Analytical R&D

Technical Proficiency: Analytical Research and development (AR&D): Formulation R&D

Job Responsibilities: Analytical Method Development, Method Validation, Method Transfer, Stability and Routine analysis.

Expert Hand in Analytical Method development and optimization by HPLC of Finished Oral Solid Formulations ANDA filings products for Assay, Related substances, Dissolution Method analysis as per USP,BP,IP as per EU/USFDA Guidelines.

Developed and validated method for the HPLC analysis of Related substance, Assay, Dissolution.

Method verification of vendor methods, compendia methods & pending monograph methods as a part of compendia review and compliance for drug substances and drug products. Method equivalency study for compendia methods in-house methods.

Performed assay, related substance analysis, excipients compatibility study, content uniformity by HPLC and In vitro pharmacokinetic study like dissolution and diffusion study of pre formulation batches and stability batches

Responsible for developing analytical methods by HPLC for drug substances and formulations for regular ANDA filings in the US and for filings in Europe, Japan market.

Time optimized method Validation and development of formulations by HPLC.

Analytical Method Development (By HPLC) and Validation for various ANDA projects as per ICH guidelines. Support to the Formulation and Development department with the Excipient compatibility studies.Proficient knowledge about HPLC, UV, diffusion apparatus and dissolution apparatus (I, II, III, IV, and V).

Experience with managing and creating infrastructure for analytical software such as Empower 3(custom calculations) Assay, Dissolution,CU.

Key Responsibilities in Method development: HPLC

Analytical method evaluation as Pharmacopoeia/Non-Pharmacopoeia & Vendor methods

Analysis of all developmental formulations in comparison with innovator products to certify the In-house products by HPLC.

Provide analytical support for formulation development of Solid dosage form &API & injectables.

Performing mini-validation for development methods by HPLC.

Evaluation of Vendor methods for the selection of cost effective API for the formulation.

Participating in method/technology transfer activity by coordinating with receiving and originating laboratories to complete the task effectively.

Responsible to method validation related regulatory queries/deficiencies.

Others Responsibilities:

Stability studies are routinely performed at various under conditions of different temperature & Humidity (as per ICH guidelines) stability of APIs& formulations.

Forced Degradation and Stability studies for Drug Substance and Drug Product.

Manage regulatory and compliance aspects of stability testing & responsible for data compilation& writing of stability reports.

Responsible for assigning product expiration dating & archival of stability documents & manage inventory of GMP sample

Stability experience is a strongly preferred stability studies requirement and expiration dates are covered in the current, GMP, USP and FDA.

Stability testing of laboratory R&D batches, commercial and Plant batches stability samples and Coordinating with R&D & PDR lab for stability & holding time study related analysis and issues.

Experience working in a quality organization in a cGMP environment.

Good documentation practices and complies with EU / USFDA regulations

Other Responsibilities:

To provide support to DRA for providing analytical data for regulatory queries by developing the analytical methods and by generating the data as per query requirement within the stipulated time.

To support Pharmacopoeia updates and timely evaluation of Pharmacopoeia Forum methods (EP, USP and IP) of in-house API’s by carrying out day to day planning, providing technical support and guidance to the Chemist and ensuring that all activities are carried out as per the predetermined timelines.

Provide analytical support for formulation development of Solid dosage form & injectables by HPLC.

Routine analytical testing for formulations development activities including assay, Dissolution testing, Related Substances, content uniformity & Purity by HPLC.

Analysis of pharmaceutical raw materials as well as finished products as per USP, BP, IP.

Drug-Excipient Compatibility / pre-formulation Study of different formulations.

Other Responsibilities:

Responsible for ensuring all the analysis are testes and records in full compliance with GLP & cGMP and regulatory requirements.

Operation and Troubleshooting of sophisticated instruments Like HPLC,Dissolution UV, IR, etc

Training given to junior chemists to operate HPLC, GC, UV, IR, Dissolution apparatus and

analytical instruments.

Conduct installation of instruments and establishing the operating procedure for the same.

Responsible for maintaining sound EHS working conditions, practice in his\her assigned areas.

Software Knowledge and Instruments Handled

Empower network server software of Waters (Build 1154), Empower-1, 2,3network server software, Waters Millennium 32 (ver. 3.2), Ezchrom software, Agilent LC 3D Chemstation (Rev. A 08.03), Metrohm autotitrator software Tiamo 836 and Tecan software Megallan5,LIMS software

Software Knowledge and Instruments Handled

NuGenesis database Management System (SDMS) &C class Software Data Management

HPLC,UPLC(Waters,Agilent,Shimadzu),Dissolution,UV/Vis,IR(Shimadzu&Perkin Elmer,) GC ((Shimadzu & Perkin Elmer, Agilent).

SGS, Gurgaon Training Programme:

Participated in Two days Estimation of Uncertainity Measurement imparted by MTGC as per the analytical the requirements of ISO/IEC-17025.( Multi Task Group of Consultant-a Division of Varsha Educational & Development Society, Hyderabad) at SGS India Pvt Limted,Life Science Department,Gurgaon during Aug’2013

M.sc Project work (May2003)

Analysis of homologues of hydrocarbons by Gas Chromatographic(GC) Technique at Indira Gandhi Centre For Atomic Research (IGCAR), Kalpakkam under the able guidance of the Dr.P.R.Vasudeva Rao, Associated Director, Chemical Group.India

R&D Centre of Sami labs ( From Nove'2004 to Oct' 2005) Worked as a Trainee-Analytical

(Fine chemicals, cosmeuticals, Standardized Herbal Extracts, Natural Products, Organic Minerals, Oils, Nutraceuticals,India

Industrial Training (May2002)

Sakthi Sugars Private Limited -Quality control laboratory-, Coimbatore.India

Papers Presented in Refereed Conferences

Participated in Two days National Level Work Shop in Industrial Metal Finishing and Electroplating at CIT during July 2002,Coimbatore.Tamilnadu

Participated in one day National Level Students Symposium on Water Pollution Cause, Consequences and Cures at National Institute of Technology- NIT-REC, Trichy during October 2001,Trichy.Tamilnadu

Education

2001-2003, M.Sc., (Master of Science) from Bharathiar University, India,Grade: I Class

1998-2001, B.Sc., (Bachelor of Science) from Bharathiar University, India, Grade: I Class

Gender: Male,

Languages: English

I solely declare that all the data provided is true to my knowledge.

Name: Gopalsamy Rangasamy

Place: Newyork

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