Formulation R&D and technology transfer

CURRICULUM VITAE

Dr. Durga Prasad Pattanayak M.Pharm, Ph.D.

Mobile No.: +919********* Mail Id.: *********@*****.*** Akash Bungalows, Soroda Road, Ahmedabad.

Carrier Objectives:

To continue successful Formulation Research & Development practice in

Generics with exceptional hands-on experienced from Concept to Completion, where my qualification and experience can enhance organizational operational development, profit growth, mission objectives, efficiency, resource utilization and employee satisfaction.

Total Experience:

Competent professional with 15+ years of experience in Formulation R&D for USA, EU, RoW and Domestic markets.

New Product Selection

Strategy Preparation

Costing & Budgeting

Regulatory Query responses

New Product Development (FDD) Process/ Trouble Shootings

Quality Management

Project Planning & Scheduling

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Key Career Exposures:

* Formulation research development of various dosages i.e. Solid oral, Liquid oral, Topical and Injectable products for various markets.

* Strategy preparation with design around opportunities to deliver Bio-equivalent products.

* Experience from proof of concept stage to production scale on QbD approach for ANDA,

NCE-1, FTF and 505B-2 formulations.

* Exposure in the formulating special products like ODT, Sublingual, mouth dissolving, tab in

tab and bi-layer tablets (IR/DR/ER formulation).

* Experience in handling deficiencies for several products from various regulatory agencies of

USA, EU and ROW.

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Employment history:

Current Employer:

J. B Chemicals & Pharmaceuticals, Research & Development, Ankleshwar, Gujarat, India

Designation: Sr. Manager-Research & Development (FDD & ADL-US/EU/RoW/Domestic) Period of Experience: April 2018 to till date.

Previous Employers

Cadila Pharmaceuticals, Formulation Research & Development, Ahmedabad, India Designation: Manager-Formulation Development & ADL (US-ANDA/EU/RoW) Period of Experience: Jan 2017 to April 2018.

Hetero Drugs Ltd., Formulation Research, Jeedimetla, Hyderabad, India

Designation: Group Leader-II – Formulation & Analytical Research. (US-ANDA/EU/RoW) Period of Experience: Feb 2015 to Jan 2017

Dr. Reddy’s Lab. Ltd. Formulation Research, IPDO Bachupally, Hyderabad, India Designation: Assistant Manager– Formulation Research. (US-ANDA/EU/RoW) Period of Experience: Feb 2010 to Feb 2015.

Alkem Laboratories Ltd., Taloja, Navi-Mumbai, India Designation: Research Scientist – Formulation Research. Period of Experience: Dec 2008 to Feb 2010

Zydus Cadila Healthcare, PTC, Ahmedabad, India Designation: Research Associate – Formulation Research. Period of Experience: Jan 2006 to Dec 2008.

Current Job Responsibilities:

Leading Formulation R&D for development, planning, organizing and directing all operations related to the growth of ongoing research and development.

Drives product development from concept to final launch, including technical and process details.

Develops relationships with experts in academia, industry, and the government to further innovation.

Collaborate with quality control to ensure the appropriate product is produced.

Motivate, develop, and train staff to reach desired production and quality goals.

Track, analyze, and control costs, schedule, quality, and customer satisfaction.

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Ensures Literature/Patent search and review of development strategy (DS) in consultation with IPM, RA, Bio, SCM citing the critical issues and make a road map with timelines for exhibit, filling and commercialization of products.

Takes care of application and monitoring of all logistic activities like Test License, Import License (API/Innovator samples), BE-NoC and Manufacturing License in appropriate time. Ensures Planning of API, excipient, innovator and tooling procurement and execution of projects.

Takes care of pre-audit / internal audit preparation for products at R&D.

Provides technical training to new comers & assisting juniors on technical skills, soft skills and result oriented communication skills.

Strengths

Reliable, trustworthy person with good soft skills & interpersonal association. Hard working and proactive person who believe in team work.

Educational Detail

Doctor of Philosophy in Pharmaceutics

Year of Passing: 2009-2012 (Awarded)

Berhampur University, Bhanja Bihar, Berhampur, Ganjam, Odisha.

Master of Pharmaceutical Sciences (M. Pharma)

First class: 79% (Year of Passing: 2004-2006)

Institute: Institute of Pharmacy and Technology, Odisha.

Bijupatnaik University of Technology, Orissa, India.

Bachelor of Pharmacy, (B. Pharma)

First class: 70.51% (Year of Passing: 2000 – 2004)

Institute: College of pharmaceutical sciences, Mahuda. Berhampur, Orissa.

University: Bijupatnaik University of Technology, Orissa, India.

Higher Secondary School Certificate (12th Class)

First class: 67 % (Year of Passing: 1999)

Institute: Anchalika Mahavidyalaya, Jagannath Prasad, Orissa.

Secondary School Certificate (10th Class)

First class-65 % (Year of Passing: 1997)

Institute: Judhistir Vidyapitha, Jagannath Prasad, Orissa.

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Patent Publication:

Stable Pharmaceutical Compositions of Olanzapine and Process for their preparation,

International Publication No.: WO 2010/134097 A2.

Paper Publications:

Formulation and development of sustained release bi-layer tablet for biphasic drug release: A novel approach in management of diabetes. J. Pharm. Res., 4(7), 2025-2031 (2011).

Design and evaluation of a fixed dose combination formulation of valsartan and metformin HCl for biphasic drug release: A novel approach to increase therapeutic efficacy. Int. J. Pharm. Sci. Tech., 6 (1), 44-63 (2011).

Design and evaluation of an extended release tablet dosage form of class-II drug, Quetiapine Fumarate, Int. Res. J. of Pharm., 2(3), 121-124 (2011).

Bi-layer tablet formulation of metformin hydrochloride and glimepiride: A novel approach to improve therapeutic efficacy, Int. J. of Drug Dis. and Her. Res., 1(1), 1-4 (2011) Formulation and in-vitro, in-vivo evaluation of a novel fixed dose combination of a bi- layered tablet of Atorvastatin Calcium, Pioglitazone HCl and Metformin HCl. Communicated to AAPS PhaSciTech., (2015) (AAPST-D-13-00515)

Seminar and Conference attended:

CPhI & P-MEC, India Expo centre, Greater Noida, Delhi NCR (Nov 2019).

CPhi 5th Annual InnoPack Pharma Confex, a UBM event, Shara Star at Mumbai, (June 2018). ExActODT Innovation with ODT technology by BASF Pharma Lab, Mumbai, India (2013). 8th International Symposium (2008) on Advances in Technology and Business Potential of NDDS by Controlled Release Society-Indian Chapter at PERD Centre, Ahmedabad, India.

Personal Details Date of Birth

Languages Known Marital Status Nationality

: 2nd June 1981

: English, Hindi and Oriya. : Married.

: Indian.

DECLARATION

I hereby declare that all the information furnished above is true to the best of my knowledge.

Dr. Durga Prasad Pattanayak

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