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Assistant Manager CRD- Ipca Laboratories Ltd., Vadodara

Location:
Vadodara, Gujarat, India
Posted:
December 22, 2020

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Resume:

RESUME

PAWAN KUMAR SHUKLA, D. Phil. Mobile: +91-830*******

OBJECTIVE

"To make a positive impact in my field of activity, leading to institution/organization growth by creative application of my value based convictions, job skills and professional dexterity."

Professional Summary

Experienced 'Scientist' offering outstanding product development skill. 15+ years of experience with Pharmaceutical Industry for product development, technical operation, transfer/commercialization and manufacturing.

Skills

• New Product Development

• Planning and execution with respect to submission of Drug Master Files (DMFs) for global markets.

• Evaluation and submission of Annual reports and amendments of Drug Master Files submitted.

• R&D bench/pilot/feasibility trials

• Technology Transfer

• R&D-Lab Equipment handling

• Raw Materials evaluation

• Regulatory Compliances

• Excellent written/verbal Communication.

• Continuous Improvements

• Cross-functional Team Collaboration.

Work History

Assistant Manager CRD, continue from 11/2018

Ipca Laboratories Limited – Vadodara, Gujrat

Responsibilities

• Review of reported literature to summerise synthesis of API/Intermediate for finalization of RoS.

• Evaluation of paper RMC and paper feasibility for 2-5 schemes.

• Monitor feasibility studies, optimization and lab validation of API/Intermediate by providing scientific inputs.

• Co-ordination with Supply chain for availability of RMs for development.

• Co-ordination with IP and RA for clearance of the process for regulated markets.

• Designation of Specification of KSMs, Intermediate, Inprocess and API

• GLP and safety compliance of Lab.

• Coardination with ADL, PE and PP for smooth and successful scale up of API/Intermediateprocess.

• Generation of following documents during development of API process

(i) Product Dossier

(ii) Feasibility Report of API process

(iii) Optimisation (What if study) Report

(iv) Lab Validation report

(v) Characterisation and Structural Elucidation reportof starting materials, KSM, Intermediates, Impurities and API.

(vi) Process Transfer Document for Pilot Plant for Scale up.

(vii) TDR (Technology Development Report) as per SOP

Dy. Manager R&D, 07/2017 to 07/2018

Medicamen Biotech Limited – Bhiwadi, Rajasthan

Responsibilities

• Compliance to Good Laboratory Practices (GLP) be developing systems and procedures.

• Conduct bench trials, feasibility runs, Pilot trials and Stability studies for new product development.

• Review and submission of Process Development Report as per customer requirement.

• Preparing SOPs/Guidance documents and their compliance

• Interacted with testing laboratory to analyze, review and verify test result.

• Review of R&D documents for accuracy and adequacy as per scientific rationale and regulatory guidelines.

• To initiate self audit of R&D Labs for adherence of R&D system and procedures.

• To impart training of R&D personal in following areas which include but not limited to

(i) Quality Guidelines of Regulatory Agencies

(ii) SOPs and Guidelines

(iii) Internal Guidance Documents

• Interfaced with cross-functional team of R&D, RA, marketing, sourcing, quality, Tech. Ops, project management and contract manufacturers.

• Worked with product science and marketing to explore new ideas/innovation and costing analysis and presented with upper management.

• Collaborated with departments; scientific affairs/product science, global/regional marketing, quality, Global/regional regulatory and licensing.

• Achieved cGMP, SOP, Regulatory and all other necessary training and seminars in order to stay up-to-date in Nutraceutical Industry.

• Troubleshoot production problems relate to formulation and ensure formulations run flawless on production scale.

• Create and review production manufacturing batch records.

Associate Professor, 07/2015 to 06/2017

Asia Pacific Institute of Information Technology- Panipat, Haryana

Associate Professor, 02/2015 to 06/2015

DR. K. N. MODI UNIVERSITY, Newai (Near Jaipur) Dist.- Tonk, Rajasthan,

Associate Professor, 06/2012 to 01/ 2015.

Satya College of Engeneering And Technology-Palwal, Haryana

Group Leader (Research Scientist), 03/2010 to 03/2012

SURYA PHARMACEUTICALS LTD., Vill.- Banur, Dist.- Patiala, Punjab

• Worked on APIs (Cephalosporine and Non-cephalosporin)

• Literature search & designing the synthetic schemes of the compounds (using Sci-finder as well as by library search)

• Supervise colleagues in assigned projects

• Skilled in filing the CRAMS enquiries including making synthetic process and their costing.

• Working on synthetic routes to optimize process for intermediates and APIs, finalizing the process development with improved yield and cost reduction.

• Validation batches monitoring and preparation of technology transfer document for a particular molecule to enable technology transfer for scale- up.

• Isolation and purification of impurities by column chromatography

• Synthesis of impurities for Drug Master Files (DMFs) filling.

• Planning and execution with respect to submission of Drug Master Files (DMFs) for global markets.

• Review and submission of Drug Master Files.

• Evaluation and submission of Annual reports and amendments of Drug Master Files submitted.

• Evaluation of change control forms, deviation forms and specifications pertaining to API projects.

• Reaction Monitoring by HPLC, GC and TLC.

• Preparation of daily reports, weakly reports, molecule development report etc and reporting to General Manager R&D.

Sr. Research Associate, 07/2007 to 03/ 2010

PARABOLIC DRUGS LTD., Vill.-Sundaran, Dist.- Patiala, Punjab,.

Research Scientist, 12/2006 to 08/2007

NECTAR LIFE SCIENCES LTD., Vill.-Derabassi, Dist.- Patiala, Punjab,.

Research Scientist, 11/2005 to 11/2006

ZYDUS CADILA HEALTH CARE LTD., Ankleswar, Gujarat

ASSOCIATION WITH PROFESSIONAL BODIES

a. Member in Reviewer Board Panel of International Journal of Engineering Research and Technology (IJERT)

b. Expert Reviewer in Reviewer Board Panel of CRDF Global

c. Life time member of CHIEF ADVISORY BOARD Panel: International Journal of Engineering and Advanced Technology (IJEAT)

d. Member in Reviewer Board Panel of International Journal of Advancements in Research and Technology (IJoART)

e. Member in Reviewer Board Panel of Journal of Indian Chemical Society (ICS)

f. Member in Reviewer Board Panel of International Journalof Scientific& Technology Research (IJSTR)

g. Member in Reviewer Board Panel of International Journal Of Scientific & Engineering Research(IJSER)

h. Member in Editorial Board of International Journal of Student Research in Technology & Management (IJSRTM)

i. Member in Reviewer Board Panel of International Journal Of Scientific & Engineering Technology ( IJSET)

j. Member in Technical Advisory Board of Blue Eyes Intelligence Engineering & Sciences Publication Pvt. Ltd.

k. Member in Reviewer Board Panel of International IRA Publications Journals

MEMBERSHIP OF SCIENTIFIC BODIES

a. International Society for Environmental Information Sciences (ISEIS)

b. EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY

a. WORLD SOCIETY INTERDISCIPLINARY ANTI-AGING MEDICINE (WOSIAM)

b. British Science Association

c. OMICS Group

d. International Society of Infectious Diseases (ISID)

e. World Association of Young Scientists (WAYS)

f. International Association of Computer Science and Information Technology (IACSIT)

g. The Chinese Society of Chemical Science and Technology (CSCST)

h. Indian Academicians and Researchers Association

PUBLICATIONS IN INTERNATIONAL JOURNALS

1. Synthesis and biological evaluation of new Pyrazolinyl Derivatives of Synthestic Bibenzyl, Smriti Dwivedi, Pawan K. Shukla and I.R.Siddiqui; Indian Journal of Heterocyclic Chemistry, Vol. 25, Oct-Dec, 2015, pp. 185 -188

2. Pawan K Shukla, Arunima, Hemant Singh, J. Singh, One New Triterpenoid-O-β-D-Glycosides from the Rhizome of Picrorhiza kurroa, IJSR - INTERNATIONAL JOURNAL OF SCIENTIFIC RESEARCH,Volume : 4 Issue : 10 Oct- 2015 • ISSN No 2277 - 8179 : 4 Issue : 10 Special Issue Oct- 2015 • ISSN No 2277 – 8179

3. IR Siddiqui, PK Shukla, N Srivastava, and S Dwivedi, Synthesis and Fungitoxicity of Propenylamino and Pyrazolinylcarboxamido Derivatives of 1,2-diphenyl ethane, Pesticide Research Journal. Vol.20 No. 1, 21-26, [2008]

4. Shachi Sahu, Nidhi Srivastava, Hemant Singh, Pawan K Shukla and Prof. J. Singh, New compounds from Cyperus Scariosus, Indian Journal of Chemistry,, © Copyright 2006 Indian Journal of Chemistry.

5. Synthesis And Fungicidal Activity of 4, 4'-Bis(2"-aryl thiazolo (4,3-b)- 1,3,4-oxadiazolo-5"-yl) methoxy) Bibenzyl; I.R.Siddiqui, Smriti Dwivedi, Pawan K. Shukla, Pravin K. Singh; Journal of Indian Chemical Society, 83, 2006, 89-93.

6. Synthesis Of Antifungal 4,4'-Bis(thiadiazolyl/triazolylmethoxy) Bibenzyl; I.R.Siddiqui, Smriti Dwivedi, Archana Srivastava, Pawan K. Shukla, Pravin K. Singh; Indian Journal of Heterocyclic Chemistry, Vol. 14, Jan-March, 2005, pp. 251-252.

7. Microwave Induced Expeditious Synthesis And Fungicidal Activity of Novel Heterocyclic Bibenzyl, I.R.Siddiqui, Jaya Singh, Pravin K. Singh, Pawan K. Shukla and J. Singh; Indian Journal of Heterocyclic Chemistry, Vol. 14, Jan-March, 2005, pp. 2314. -23.

COMMUNICATED

1. Two New compounds from the Pongamia pinnata; Nidhi Srivastava, Hemant Singh, Pawan K. Shukla and J.Singh; Indian Journal of Chemistry.

2. Highly diastereoselective synthesis of 2,6-diaryl-3-(b-D-gluco-or-b-D-galactopyranosyl)-2,3-dihydrothiazolo[3,2-a]-4H-1,3,5-triazine-4-thiones: Pawan K. Shukla, Daya Ram Pal and Ibadur R. Siddiqui; Synthesis

3. Synthesis of new peptidyl (or amino acid) derivatives of imidazo[2,1-b]-1,3,4-thiadiazoles as potential antivirals; Pawan K. Shukla, Daya Ram Pal and Ibadur R. Siddiqui; Indian Journal of Chemistry

INTERNATIONAL/NATIONAL CONFERENCES

1. One New Triterpenoid-O- -D-Glycosides from the Rhizome of Picrorhiza kurroa, Pawan K. Shukla1, Arunima2, Hemant Singh3 and J. Singh4, National Conference on Recent Innovations In Applied Sciences & Humanities (NCASH-2015), 10th October, 2015

2. Education and Employability: A Growing Mismatch, Dr. Bhumija Chauhan, Samreen Fatima, Dr. Pawan K. Shukla, International Conference on Management & IT (ICMIT-2015), 10-11April 2015

3. Impact of Human – Environment interaction, Pawan K Shukla, Jaggi Lal, Anamika Sharma, Recent Trends in Innovation in Social Sciences, Management & Technology (RTISSMT2015), 21st March 2015.

4. Work Life Balance- A Global Concern and India, Pawan K Shukla, Samreen Fatima, Recent Trends in Innovation in Social Sciences, Management & Technology (RTISSMT2015), 21st March 2015*.*Got best paper award for this paper.

5. Invited to chair a session and keynote speaker in an International Conference on “Applied Science and Engineering” on Oct. 19, 2014.

6. Nominated in National Executive Council of GIAP Journals in its First International Conference on Biological, Chemical & Environmental Sciences ICBCES 2014 in New Delhi on 23rd August 2014.

7. Invited to chair a session and keynote speaker in an International Conference on on “Emerging Trends in Science and Technology” during July 22-23, 2014, organized by Sri Satya Sai University of Technology and Medical Sciences, Sehore(Bhopal) M.P.

8. One new Triterpenoid-O-D-glycosides from th rhizomes of picrorhiza kurroa, Hemant Singh, Arunima, Pawan Shukla and J.Singh; “Chemical Sciences section of 101stIndian Science Congress”, University of Jammu (Feb 3-7, 2014)

9. Two Triterpenoid Glycoside From The Stem Bark Of Samanea saman; Nidhi Srivastava, Hemant Singh, Pawan K. Shukla, Shachi Sahu, Arunima Pandey and J.Singh; Indian Science Congress-2005 (3-7 January, 2005)

10. Synthesis and Biological Evaluation of Natural Bibenzyl Derivatives; I.R.Siddiqui, Pawan K. Shukla and Nidhi Srivastava, National Seminar on “New Horizons in Life sciences” (2-3 September, 2005).

11. Two New Compounds From The Stem Bark of Samanea saman; Nidhi Srivastava, Hemant Singh, Pawan K. Shukla, Shachi Sahu, Arunima Pandey and J.Singh; National Seminar on “New Horizons in Life sciences” (2-3 September, 2005).

12. Phytochemical study of Picrorhzia kurroa; Arunima, Hemant Singh, Pawan K. Shukla, Nidhi Srivastava, Shachi Sahu, and J.Singh; National Seminar on “New Horizons in Life sciences” (2-3 September, 2005).

13. New Flavone Glycoside from the Rhizomes of Cyperius scariosus; Shachi Sahu Nidhi Srivastava, Hemant Singh, Pawan K. Shukla, Arunima, Priyanka Maurya and J.Singh; National Seminar on “New Horizons in Life sciences” (2-3 September, 2005).

14. Synthesis And Biological Evaluation Of New Pyrazolinyl Derivatives Of Synthetic Bibenzyl, I.R.Siddiqui, Pawan K. Shukla, Hemant Singh, Nidhi Srivastava, Smriti Dwivedi, 7th Conference of International Academy of Physical Sciences, (December 21-23, 2004).

15. Synthesis And Fungicidal Activity of 4,4'-Bis[N- (2"-aryl-4”-thiazolidinon- 3”-yl) acetamidoxy] Bibenzyls; I.R.Siddiqui, Smriti Dwivedi, Pawan K. Shukla, Shalini Jaisawal, Naz A. Siddiqui, 7th Conference of International Academy of Physical Sciences, (December 21-23, 2004).

ACADEMIC QUALIFICATION

1. Ph.D. (Organic Chemistry, Titled: Synthetic Study of Antifungal Heterocyclic Compounds) awarded from University of Allahabad (U.P.)-India in year 2004.

2. M.Sc. (Oganic Chemistry) from Udai Pratap College, Varanasi (U.P.)-India, 1999

3. B.Sc. (Chemistry Group) from Udai Pratap College, Varanasi (U.P.)-India, 1997

4. 12th (Intermediate, Maths Group) from Uttar Pradesh Board Allahabad, 1994

5. 10th (High School, Science Group) from Uttar Pradesh Board Allahabad, 1992

RESEARCH EXERIENCE

Ph.D (August 2001 to December 2004), Institute: Department of Chemistry, University of Allahabad, INDIA

Research Associate (Sept. 2004 to Oct.2005), Institute: Department of Chemistry, University of Allahabad, INDIA

Project Title: Phytochemical study of some plant constituents under the supervision of Dr. J. Singh (January 2000 to July 2001), Institute: Department of Chemistry, University of Allahabad, INDIA

STRENGTH

Hard working, quick learner, punctual, deterministic and believe in teamwork.

CURRICULAR ACTIVITIES

Sports

Seminar

PERSONAL PROFILE

Father’s Name : Shri Bechan Shukla

Date of Birth : 27th December. 1976

Nationality : Indian

Language Known : English, HindiEnglish, Hindian

Mobile No : +91-830*******

E-mail : drp adiv23@r.postjobfree.com

REFERENCES

1. Dr. Brij Kishor Gupta, D.G.M. R&D, JDM Scientific Research Organisation (P) Ltd, Lasundra, Savli, Vadodara Gujrat, Mobile: +91-909*******, e-mail – adiv23@r.postjobfree.com

2. Dr. B. Manivannan, Sr. G.M. (R&D & RA), Medicamen Biotech Limited - Bhiwadi (Rajasthan), Mobile: +91-703*******, e-mail – adiv23@r.postjobfree.com

3. Dr. D. R. Pal, Principal Scientist, Zydus Cadila Healthcare Limited - Vadodara (Gujrat), Mobile: +91-966*******, e-mail – adiv23@r.postjobfree.com

DECLARATION

I hereby affirm that the details disclosed above are true to my knowledge. I also assure that I would put in my best efforts if given an opportunity.

Date:

Place: Vadodara (Gujrat, India) (DR. PAWAN KUMAR SHUKLA)



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