Akhilesh Kumar Yadav

Mobile : +919*********, +959*********

Viber No. +950********* WhatsApp No. +919********* E-mail : ad37hu@r.postjobfree.com

To pursue a challenging career and be part of a progressive institution that gives scope to enhance my knowledge, skills and to reach innovatively the pinnacle in analytical R&D/F&D Field with sheer determination, dedication and hard work. CAREER OVERVIEW

Acquired comprehensive exposure in planning and organizing day-to-day research & development activities and executing tasks on molecules for the submission of ANDA and ROW.

Developed and validated a good number of Analytical Methods for the Pharmaceutical products, API and NCEs.

Performed Method Investigations, Method Verifications and Trouble Shooting.

Played a key role in facing the regulatory audits.

Team player with strong communication & analytical skills. Possess a flexible & detail oriented attitude.

Quick to learn and implement new scientific research methodologies.

An energetic, self-motivated team player with hands on experience in requirements gathering, examination, evaluation and customization.

SCHOLASTICS

M.Sc. in Bio-Technology (2008-2010)

IAMR Ghaziabad (C.C.S. University Meerut Uttar Pradesh) B.Sc. in Chemistry (2005-2008)

HRPG college (D.D.U. University Gorakhpur Uttar. Pradesh) 12th (2005)

HRIC (U.P. Board)

10th (2003)

HRIC (U.P. Board)

WORKING EXPERIENCE

Currently working as Group Leader in the Department of Analytical Research and Development for Pacific Medical Industries Ltd., Myanmar, since Mar 2018.

Worked as Sr. Research Scientist in the Department of Analytical Research and Development for Felix Generics Pvt. Ltd, Greater Noida, Uttar Pradesh from Apr 2016 to Mar 2018.

Worked as Sr. Research Associate in the Department of Analytical Research and Development for Gracure Pharmaceutical Ltd, Bhiwadi, Rajasthan from Dec 2014 to Mar 2016.

Worked as Scientist for Multani Pharmaceutical Ltd, Roorkee Haridwar in Analytical Division from Feb 2013 to Nov 2014.

Worked as Analyst for Avon Lab Pvt Ltd, Lawrence Road Delhi in the department of Method development and validation from Aug 2010 to Jan 2013.

WORKING EXPERIENCE IN

Analytical method development and validation by HPLC and UPLC for API and Finished Products and by Dissolution Apparatus for Finished Products.

Impurity profiling of various API and their characterization.

Method transfers and method verifications.

Calibration of analytical instruments.

Long term stability studies.

PRESENT JOB RESPONSIBILITIES

Proper planning, guiding the team members and monitoring the following activities in Analytical Research and Development Department:

Analytical method developments and validations by HPLC, UPLC, UV-Visible Spectrophotometer and Dissolution Apparatus.

Analytical method developments and validations for the tests of Assay, RS and Dissolution.

Drug –excipient compatibility studies, water content determination and Biomedia Dissolutions for finished products supporting FR&D.

Analytical method developments and validations by HPLC and UPLC for the tests of Assay and RS of API.

Calibration of the instruments as per Standard Operation Procedures (SOPs)

Working standard Qualification.

Method verification of the Compendial methods.

Method transfers from the department of ARDL to CMOs and Client locations.

Preparation of method development and validation protocols, method transfer protocols, method development and validation reports and STPs.

Preparation of Specifications for drug substances and drug products.

Review of method development, validation and method transfer protocols, method development and validation reports, regular and stability analysis reports and STPs.

Assisting FR&D team in selection and optimization of excipients for Formulation development.

Planning the regular works to the team members.

Planning and providing required trainings to the team members.

Guiding the team members to meet the regulatory requirements.

Participating in technical discussions with project teams and assist in troubleshooting and finding solutions.

Perform all laboratory works with proper planning and scheduling of jobs.

Assisting the QA in ensuring the quality.

Co-ordinating with regulatory affairs team for regulatory requirements.

Continuously Assisting the clients at the best by directly onsite support or through telecons in troubleshooting, solving the technical issues and in answering the queries.

PROJECTS HANDLED

Analytical method development and validations for the test of Dissolution, Assay, Related substances of formulations and API by HPLC and UV.

Analytical method validations for the test of Blend Assay of formulations by HPLC and UPLC.

Analytical method development and validations for the test of Residual Solvent of API and formulations by HPLC.

Analytical method development and validations for the test of cleaning methods by HPLC.

Analytical method development and validations for the test of Assay of formulations and API by UPLC.

Dissolution profiling for matching of Difference factor (f1) and Similarity factor (f2).

Drug and Excipient Compatibility studies.

Forced degradation studies for the test of Related substances.

Stability and Regular Analysis of Finished products, Intermediates and APIs. EXPERTISE HANDS AT

HPLC instrument (Waters 2695 Autosampler, Shimadzu LC-2010AHT, Agilent)

UPLC (Waters Equity)

UV-Visible spectrophotometer (Varian Cary 100, Perkin Elmer, Agilent, Lab India)

FT-IR instrument (Varian 643, Perkin Elmer, Agilent)

Disso DS 14000 Dissolution Test Apparatus (Electrolab, Lab India, Distek)

Distek 2100C Tablet Dissolution Tester.

Karl Fischer (Mettler Toledo),

OTHER INSTRUMENTS HANDLED

Gas Chromatograph with Headspace Sampler.

Preparative HPLC(Shimadzu)

AAS (Agilent)

AUDITS AND INPECTIONS FACED

TGA

ISO 17025 (NABL, ANAB)

WHO

GLP

GMP

Several Customer Audits from India and many other countries. TYPES OF PRODUCTS HANDLED

Solid Orals.

Liquid Orals

Semisolid preparations

Parenterals.

APIs.

Intermediates.

WORKED ON PRODUCTS FOR

U S Market.

IDA.

European Market.

ROW Market.

ACHIEVEMENTS

Recognized as “BEST SCIENTIST AWARD” for FY 2016-17 in Felix Generics Pvt. Ltd.

Selected for international training on “Method Development & Troubleshooting” organized by Agilent Technologies, Singapore.

Qualified ISO 22000 – Lead Auditor’s training.

Qualified ISO 17025 – Internal Auditor’s training. M.PHARM. DISSERTATION DETAILS

Plasmid isolation, Identification, Purification and Characterization from Pseudomonas. IT SKILL SET

Basics: Computer Fundamentals, Internet Knowledge.

Other Packages: Empower 2.0, Empower 3.0, Ezchrome, Chemstation & Lc solution software in HPLC, MS Office 2007. AS A MEMBER OF THE ORGANIZATION, I CAN PROVIDE

Maturity, honesty, ability to look at great challenges as great opportunities.

Enthusiastically hard working in a highly interdisciplinary and collaborative environment for creation and communication by Industry- Institute Interaction and Ability to develop and lead a team.

Ability to work under pressure and can be a good team member either as a lead or as an individual. PERSONAL DOSSIER

Date of Birth : 03.08.1988

Father’s Name : Shri. Rajpati Yadav

Address : B-58 Veena Nagar Sukhaliya, Indore Madhya Pradesh, 452010, India

Sex : Male.

Nationality : Indian.

Marital Status : Married.

Linguistic Abilities : English, Hindi.

DECLARATION

I hereby declare that the information furnished above is at the best of my knowledge.

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