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Narottam Shinde

Narottam Shinde

Research Associate - Formulation Development

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location of Narottam ShindeGreater Hyderabad Area

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  • Timeline

  • Skills

    Hardworking and dedicated to anda development
    Regulatory affairs
    Generic programming
    Formulation
    Pharmaceutical research
    Patents
    Solid oral dosage forms
    Gmp
    Sop
    Pharmaceutical industry
    Validation
    Drug delivery
    Glp
    Hplc
    Technology transfer
    Dissolution
    Anda
    Pharmaceutics
    Regulatory submissions
    Fda
    Drug development
    Clinical trials
    Pharmacokinetics
    Regulatory requirements
    Quality by design
    Cleaning validation
    Mentoring
    Standard operating procedure
    Abbreviated new drug application
    High performance liquid chromatography
    Patent law
    U.s. food and drug administration

  • About me

    ... Jagsonpal Pharmaceuticals Ltd. Location: Udham Singh Nagar, Uttarakhand, India; Industry: Pharmaceuticals ... July 2014 – December 2015 (1 year 6 months)Mumbai Area, India .... singh kochhar. Owner, jagsonpal pharmaceuticals limited...

  • Education

    • Institute of Pharmaceutical Education Research

      2014 - 2015
      Diploma in Pharmaceutical Packaging and Management First Class

      Activities and Societies: Imbibing the criticality of Pharmaceutical Packaging Looking at current FDA perspective with respect to packaging of pharmaceutical products has made me to enroll for the said course, so as to gain the depth knowledge and expertise in understanding the criticality quality attribute involved in pharmaceutical packaging.

    • Institute of Pharmaceutical Education Research.

      2013 - 2014
      Diploma in Quality Control & Quality Assurance First CLass.

      Activities and Societies: Acquired Knowledge of Quality Control & Quality Assurance. Acquiring knowledge and understanding role & responsibilities of quality control and quality assurance had made me more confident and step closer to accomplishment of pre-defined Goal.

    • GNA's Patent Gurukul.

      2009 - 2010
      Post Graduate Diploma in Patent Law & Practice Patent Law Grade:- First Class

      Activities and Societies: Acquired knowledge of patent law and its application in Pharmaceuticals Recognized the way pharmaceutical industry thrust for growth and proving their efficiency through first to file in same context wished to acquire a thorough knowledge of patents law and its implementation in pharma industry.

    • Clinical Research Education and Management Academy

      2007 - 2008
      Post Graduate Diploma in Clinical Research. Bioequivalence Study Grade:- First Class.

      Activities and Societies: Acquired Knowledge of Bioequvalence study and Interpretation of Invivo Bioequivalence results Had a vision to grow into the field of generics, hence first got engrossed with product development activities/knowledge wherein understood the importance of clinical trials specifically bio-equivalence study which need to proved as per regulatory requirement hence, this was a first step forward towards career goal and accomplish the same by attending part time classes for a year and finally rewarded by PG Diploma in clinical Trials with a First Class Grade.

    • Poona College of Parmacy

      2000 - 2002
      Master of Pharmacy Pharmaceutis & Quality Assurance. First Class

      Activities and Societies: Secured distinction in Quality Assurance Techniques-I Research Topic : Formulation and Release Characteristic of Hydroxy Propyl Methyl Cellulose Effervescent Floating Matrix Tablet Containing Diltiazem Hydrochloride”The main objective is to “develop and evaluate a multi-functional drug delivery system which consisted of a hydrophilic matrix tablet, to give various extended drug release profile, including gastric retentive, pulsatile and the device which could not interfere in drug release in colon.

    • MGV's College of Pharmacy,

      1996 - 2000
      Bachelor's degree Pharmaceutical scieces Second Class

      Activities and Societies: Industrial Training: Brighto Pharma, Sharanpur (Delhi), Oct 1997-Nov 1997 Summery: Gained knowledge in dept like Production, Quality Control, Packaging and Stores. Graduated with Bachleros degree in pharmaceutical sciences.

    • Canossa Convent High School, Dhule

      1992 - 1993
      Secondary School Certificate Second Class

      Activities and Societies: Class 10th

    • Insight Professional Academy

      2023 - 2023
      Diploma in Quality GMP Auditing. Auditing Skills Distinction

      Module I - Internal Audit : Introduction and Overview.Module II - GMP Auditing EssentialsModule III - The breadth and depth of internal auditingModule IV – Mechanics of operation of internal auditsProject Report - Internal Auditing

    • KES'S PRATAP COLLEGE, AMALNER.

      1994 - 1995
      Higher Secondary Certificate Second Class

      Activities and Societies: Class10+2

    • Simplilearn Alumni

      2020 - 2021
      Six Sigma Black Belt / Expert. Efficiency & Productivity Improvement Distinction

      Activities and Societies: A step ahead from research & development activities, Exhibit batch manufacturing, product filing in regulated market followed by approval is commercialization wherein Pharmaceutical industry is noticing declining profits as there is now much opposition coming from generic brands and faults within the manufacturing process. In order to improve this, many corporations are struggling to increase effectiveness within the manufacturing and operational processes. Six Sigma or Lean Six Sigma… Show more A step ahead from research & development activities, Exhibit batch manufacturing, product filing in regulated market followed by approval is commercialization wherein Pharmaceutical industry is noticing declining profits as there is now much opposition coming from generic brands and faults within the manufacturing process. In order to improve this, many corporations are struggling to increase effectiveness within the manufacturing and operational processes. Six Sigma or Lean Six Sigma is a tool which decrease operational costs and ensure great service to their clients. The six-sigma quality improvement theory allows businesses to constantly improve and change the industry in a positive direction therefore, corporate is able to forecast and destroy errors and therefore give a much-needed boost to operative efficiency. Finally, use of Lean Six Sigma in statistical terms ensures that in every one million activities, only 3.4 defects or less occur. Show less

  • Experience

    • Emcure Pharmaceuticals Limited

      Jan 2004 - May 2006
      Research Associate - Formulation Development

      Domestic experience for a year followed by shouldering the responsibility of ANDA Lab Setup and finally appointed as a first person to work on generic drug development, ANDA Submissions for US Mkt.

    • AUROBINDO PHARMA LTD

      May 2006 - Jan 2009

      - Aurobindo Pharma, leaders in generic development and regulatory fillings for US & EU Mkt.- A company where the concept of "ANDA" got cleared, highly motivated towards making the career in "generics" wherein the goal was set with vision to be an subject matter expert in "ANDA" development.- Excellent support from colleagues and boss who handed over company's KRA products wherein, worked day in and out & formulated a "Bio-equivalent" Product - In hand experience of handling Solid & Liquid Dosage form, from pre-formulation to EB Mfg. - A company, where all working hands on project right from scientist, team leader use to have round table discussion on "Product Progress, Setting Specification, Exhibit Batch Results, IVIVC Co-relation & finally Bio-Equivalent Report" Felt lacking in Pk data interpretation hence, got enrolled & acquired First Class grade in "Post Graduate Diploma in Clinical Trials" (BABE Study) CREMA, Mumbai. Show less

      • Research Associate IV

        Oct 2007 - Jan 2009

      • Research Associate III - Formulation DeVELOPMENT

        May 2006 - Sept 2007

    • Rusan Pharma Ltd, Mumbai.

      Jan 2009 - Jul 2010
      Manager - Formulation Dept.

      A different segment of pharmaceutical where successfully proved my capabilities by developing a sub -cutaneous implant with a predefined release pattern for a month. Faced N-Numbers of challenges right from seeking local FDA license, Patent hurdles, followed by product development within stipulated time frame, and export into Russian market. The developed subcutaneous implant was subjected for clinical trials in Russia and was well appreciated by Russian doctors. In-addition had another great opportunity in developing number of generic injectable (PFS) dosage forms. Career Path: This was phase wherein understood importance of patents hence, got enrolled & acquired First Class grade in "Post Graduate Diploma in Patent Law & Practice" GNA Patent Gurukul under guidance of "Dr. Gopakumar Nair" Show less

    • Famy Care Ltd., Mumbai

      Jul 2011 - Jul 2014

      - Excellent opportunity of handling high potent hormonal formulations dose as low as 10mcg. - Key person involved in USFDA Audit & providing responses raised by auditors.- Acquired leadership qualities via handling a team of scientist. - Career Path: This was the phase when understood the importance of Quality Function (QA & QC) hence, got enrolled and acquired first class position in "Diploma in Quality Control & Quality Assurance"

      • Senior Principal Scientist

        Jul 2012 - Jul 2014

      • Manager (Group Leader), Level 07 - Formulation Deelopment

        Jul 2010 - Jul 2014

      • Principal Scientist

        Jul 2011 - Jun 2012

    • Ipca Laboratories Limited

      Jul 2014 - Jan 2016
      Deputy General Manager

      - Responsibility: Generic Drug Product Development for Regulated Mkt Like US, EU, AUS & WHO. - Development of High Potent Hormonal & Non Hormonal product. - New R&D, Hormone ANDA Lab Setup at Indore location. - Response provided to queries raised by regulatory authorities for products filed few years back. - Career Path: Looking at current FDA perspective towards packaging of hormonal products made me enroll for "diploma in packaging development and management, Grade - First Class" & gained in-depth knowledge and expertise in understanding the critical quality attribute involved in pharmaceutical packaging. Show less

    • Naari Pharma Pvt Ltd.

      Jan 2016 - Jun 2021

      Generic High Potent and 505(b)(2) Product development for regulated Market; US, EU, AUS & WHO. Looking ahead lean commercial manufacturing was need of market hence , enrolled for Lean Si Sigma Black belt and completed with distinction.

      • Senior General Manager

        Dec 2018 - Jun 2021

      • General Manager

        Jan 2016 - Dec 2018

    • Hetero

      Dec 2021 - now
      Associate Vice President, Research & Development, Hyderabad

      Hormone Niche Portfolio "Womens Health Niche" _ Hetero Labs, Came Up with a Sparlking New Dedicated USFDA Compliant Facility with short period of 10 months, delivered 5 ANDA's within Span of 10 Months expecting FDA Audit hence, got enrolled & completed " DIploma in Quality Auditing"

  • Licenses & Certifications

  • Honors & Awards

    • Awarded to Narottam Shinde
      Time & Task Management Global Academy, Ahmedabad Aug 2012 Attended workshop on “Time & Task Management”
    • Awarded to Narottam Shinde
      Exact Melt, Zoom into Hot Melt Extrusion through powerful partnership BASF, INDIA, Pune May 2012 Attended workshop on “Exact Melt, Zoom into Hot Melt Extrusion through powerful partnership
    • Awarded to Narottam Shinde
      Evaluation of Basic Pharmacokinetic Parameters & Conference intervals from data obtained during Bio-equivalence study using Excel worksheet Pharma Edge Centre Pvt Ltd Sep 2010 Attended Seminar on “Evaluation of basic pharmacokinetic parameters & conference intervals from data obtained during bio-equivalence study using Excel worksheet
    • Awarded to Narottam Shinde
      Advances in Technology and Business Potential of New Drug Delivery Systems Controlled release society at PERD, Ahmedabad. Feb 2008 Attended 8th International Symposium on “Advances in technology and business potential of new drug delivery systems
    • Awarded to Narottam Shinde
      Rheology of Pharmaceutical & Cosmetic Products Bharati Vidyapeeth Deemed University, Poona College of Pharmacy Aug 2003 Attended Seminar on “Rheology of pharmaceutical & cosmetic products
    • Awarded to Narottam Shinde
      Dissolution Testing of Pharmaceuticals and Therapeutic Drug Monitoring Bharti VidyaPeeth Deemed University, Poona College of Pharmacy Sep 2001 Attended seminar on Seminar on 'Dissolution Testing of Pharmaceuticals' and 'Therapeutic Drug Monitoring'