ATUL DIKSANGIKAR

ac7xg6@r.postjobfree.com

Cell No: +919*********

CURRICULUM VITAE

Objective:

To create best impact in Pharmaceutical industry by utilizing all my knowledge and skills to create innovative ideas for the development of Simple, Novel, Accurate and Economical analytical methods for Novel and Generic drugs so as to contribute to the good quality of medicine.

Profile Summary:

Over 15 years of industrial experience in analytical method development & validation of analytical methods in Formulation-Analytical Dept.

Expertise in analyzing different types of dosage forms like Tablets, Capsules, Eye Drops, Injectables, Gel, Cream and TDDS.

Preparation and Validation of Custom Fields in Empower Software for Tests like Assay, Content Uniformity and Dissolution etc. Excellent knowledge about Empower software.

Successfully faced USFDA Audit in 2016 and 2018 without any major observations.

Excel sheets preparation and validation for tests like Assay, Related Substances etc.

Work Experience: A total experience of 15+ years.

Sai Life Science Pvt Ltd, Pune, India

Designation: Research Scientist-I

Department: Formulation-Analytical Development Laboratory

Period : Nov 2014- Till date.

Current profile includes –

Leading and guiding team members in Analytical method development and trouble shooting of tests like Assay, Dissolution, Related Substances and IVRT.

Execution of Stability study, Diluent Compatibility, Filter/Tube compatibility, Pre-formulation study as per protocol.

Addressing OOS/OOT and Errors as per Quality Management Systems.

Work allocation and planning in discussion with formulation and project management team in order to complete the activity within timeline.

Preparation and review of technical documents like Method development reports, STP, Specifications, JOS and SOP etc.

Sharing data with client through reports, power point presentation and teleconference.

Preparation and Validation of Custom Fields for tests like Assay, CU and Dissolution in Empower software (Waters).

Recipharm Ltd (Formerly Kemwell Bio-Pharma Pvt Lt., Bengaluru, India)

Designation: Team Leader

Department: Analytical Development Laboratory

Period : Apr 2012 – Nov 2014.

Job profile –

Leading and Guiding Team members in Analytical method development of tests like Assay, Dissolution and Related Substances for different dosage forms.

Review of analytical documents like method development reports, validation protocol, validation report, method transfer protocol and report etc.

Preparation of justification for regulatory queries for USA market.

Preparation and review of Technical documents like STP, Specifications and SOP etc.

Nektar Therapeutics Ltd, Hyderabad, India.

Designation: Associate Scientist

Department: Product Development Laboratory

Period : Jan 2007 – Jan 2012

Work profile –

Analytical method development for NCE Drug Substance & Products.

Pre-formulation and Stability study to support the formulation dept.

Calibration and maintenance of analytical instruments like UPLC, HPLC, Dissolution Apparatus, UV- Spectrophotometer, KF Titrator, Analytical Balance, pH-meter etc.

Interaction with other sites (San Carlos, Huntsville) about the project queries & requirements.

Indents, procurement and stock maintenance of regular chemicals & consumables in co-ordination with sales persons & purchase dept.

Sun Pharmaceuticals Advance Research Center, Vadodara, Gujarat, India

Designation: Research Assistant

Department: Analytical Development Department

Period : Apr 2004 – Jan 2007

Work Profile:

Analytical method development, trouble shooting and report preparation of tests like Assay, RS and Dissolution for different dosage forms (Solid Orals, Injectable, Gel, Cream, Eye Drops and TDDS) for EU and USA related projects.

Analytical method validation for different pharmaceutical dosage forms and respective validation report preparation.

Analytical Method Transfer to various plant locations as per protocol.

Pre-formulation and Stability study as per protocol to support the formulation dept.

Calibration of Instruments like HPLC, Dissolution, UV Spectrophotometer, pH meter and Analytical Balance etc.

Alembic Ltd, Vadodara, Gujarat.

Designation: Executive

Department: Quality Control

Period : Dec-2003 - Apr-2004

Work Profile:

Analysis of Drug Product as per STP using HPLC, UV-spectrophotometer, Dissolution Apparatus and KF Titrator etc.

Calibration of HPLC, UV-spectrophotometer, Dissolution Apparatus, Analytical Balance and KF Titrator etc.

Seminars and Training:

Custom fields preparation and calculation using Empower software by Waters.

Dissolution method development and Validation by USP.

Analytical method development by Waters.

Academic Qualifications:

M.Sc. (Analytical Chemistry) from N.S. Wadia College, Pune, Maharashtra, India affiliated to University of Pune from June 2000 to July 2002 with First class (62%).

B.Sc. (Chemistry) from Fergusson College, Pune, Maharashtra, India affiliated to University of Pune from June 1996 to July 1999 with First class (64%).

Personal Information

Name : Atul Vasant Diksangikar,

Date of Birth : 19/01/1979

Permanent Address : Flat: 4, Plot: 17, Gayatri Apt, Varadayani Society,

Pashan-Sus road, Pune,

Maharashtra, India.

Tel: +91-020-********

Contact No. : +919*********

E mail id : ac7xg6@r.postjobfree.com.

Marital Status : Married

Language Known : English, Hindi and Marathi.

Passport No. : S0178225

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