Coating Development Executive

CURRICULAM VITAE

Dr. Syed Moinuddin Rashid

M-Pharm, Phd (Pharmacy)

H no : 4/12/34/A

New Colony,

Roshan Gate

Aurangabad

Cell No : 982-***-****

E Mail : **************@*****.**.**

Total experience: 20 Years

Number of Product field:

Experience of filing 55 products in US market and 17 products in Europe market

Current Status:

Presently working in Formulation Development with Wockhardt Research Centre, Aurangabad since January 2011 till date.

Designation: Sr General Manager (NDDS, MR& IR for US and Europe Market)

Duration: 11 Years 6 Months

Job Responsibilities: Formulation Development, Technology Transfer, Development Quality Assurance

Job Profile

ØFormulation development of drugs into different dosage forms (NDDS, MR & IR ) for US and Europe market. Major Focus on Solid and Liquid dosage form with a brisk exposure on Parentral dosage form.

ØMajor responsibility in Para IV FTF Products.

ØGuiding a team of scientist (team size 15 to 35 ) in developmental work.

ØComplete responsibility of Technology transfer from 2016 along with R & D Development.

ØPreparation and allocation of budget from initial development to validation batches. Major responsibility in presenting the budget and getting it approved from the management.

ØInvolved in Planning and execution of Analytical activities.

ØScale Up, Manufacturing and validation of Exhibit Batches for US and Europe Market Coordinating with various department for smooth running of the project

ØWorking on implementing Development activity based on Quality by Design (QBD)

ØWorking on various dosage form such as Sustained release tablets, Modified release tablets, Multi unit particulate system, Powder for solution, Chronomodulated tablets, Liquid filled in Hard gelatin capsules, injections and sustained release suspension based on Wurster technology

ØActively involved in Risk Assessment and mitigation of existing commercial products.

ØImplementing NIR based PAT activities for existing projects.

ØGuiding investigations for OOS and OOT at plant level

ØWorking and auditing third party CMOs for transferring of projects

ØReformulation of existing projects.

Achievements At Wockhardt

ØSuccessfully formulated a chronomodulated bioequivalent product for a steroidal

drug based on the geometry of the dosage form. WIPO patent application has been assigned.

ØSuccessfully formulated a liquid filled hard gelatin capsule bioequivalent to innovator

(liquid filled soft Gelatin capsule). Three USPTO applications have been published.

ØSuccessfully formulated 15 immediate release IR tablet formulations

ØSuccessfully formulated 9 matrix based Extended release tablet formulation

ØSuccessfully formulated 5 liquid suspension projects and 2 clear solution projects.

ØSuccessfully formulated one suspension project requiring characterization of API and

Formulation along with in vitro Bioassay.

ØSuccessfully formulated a sustained release multi Tablet formulation in comparison with

innovators sustained pellets dosage from. Two WIPO applications have been published.

ØSucessfully formulated Mouth dissolving film dosage form for NTI drug. Wipo patent has

been published for the same. Project under scale up stage.

ØSuccessfully addressed the issues of dissolution of a prime project of wockhardt by

Revalidating at a commercial scale (MUPS dosage form). After revalidation site transfer

also done successfully for this project

Successfully passed pilotbio studies for NTI project with NTI criteria for bioequivalence,

Carried out site transfer of 7 important projects of wockhardt across Different companies in India.

Played integral part in the established the DQA department in wockhart.

Experience

1) Worked in Drug Delivery Research Lab with USV Pharmaceuticals, Mumbai from November 2004 to January 2011

Designation: Senior pharmacist ( Grade M2 )

Duration: 6 Years 2 months.

Job Profile

ØFormulation development of drugs into different dosage forms (Solid, Liquid and lyophilized injections) for US Market.

ØGuiding scientist in developmental work.

ØScale Up and Manufacturing of Exhibit Batches for US Market

Achievements At USV

ØDevelopment and exhibit batch manufacturing of 12 products for US market

ØDevelopment and Technology Transfer of Enteric Coated pellets, Film Coated pellets and

Their subsequent incorporation in tablets and capsules

ØDevelopment of MUPS technology for certain drugs for US Market.

ØFormulation development and scale up of one injectable project based on lyophilisation.

ØWorked on various techniques such as Hot melt granulation, solid solid dispersion

Compaction, extrusion spheronisation etc.

ØInvolved in establishment of pilot plant for exhibit batches

2 ) Worked in Formulation Development Department with Glaxo Smithkline, Mumbai since June 2004 till October 2004.

Designation: Formulation Development Executive.

Duration: 4 Months

Job Profile

ØNew product development for Domestic Market.

ØTrouble shooting and development of cost effective formula for existing products

ØScaling up batches and Technology transfer to the Production Department.

ØPreparation of MFR and Development report of the project under investigation

3) Worked in Formulation Development Department with IPCA Pharmaceutical, Mumbai from July 2002 till June 2004

Designation: Research Scientist.

Duration: 2 years

Job Profile

ØFormulation development of Various drugs into different dosage forms for European and Domestic Market

ØWas involved in the initial stages of activities related to US market.

ØScaling up batches and Technology transfer to the Production Department.

ØComplete literature search including Patents, Journals, Internet and Encyclopedias

ØComplete Documentation activities of the projects under investigation

Ø Worked extensively on taste masking of bitter drugs and the subsequent formulation of the same into suitable dosage forms

Ø Formulation Development into dosage forms like Conventional tablets, Mouth dissolving tablet (Soluble Tablets), Chewable tablet, Dispersible tablet, Enteric coated tablet, Capsules, Dry Syrup, Readymix syrup, Liquid Syrup, Drops, Injection.

Qualification

ØPhD From UDCT, Aurangabad

Thesis Title “Bitter taste masking novel formulation development and stability assessment of Antidepressant drug” Published 1 International and 3 National papers on PhD work.

ØPassed M Pharmacy in First division in January 2002 from NDMVP college of Pharmacy, Nasik Pune University

ØQualified GATE with percentile score 90.63

ØPassed B Pharmacy in First division in May 1999 from YBC College of Pharmacy,Aurangabad (Dr BAM University)

ØPassed H.S.C. with Distinction in March 1995 from Maulana Azad college, Aurangabad (M.S.Board)

ØPassed S.S.C. with Distinction in the year March 1993 from SFS Convent school,Aurangabad (M.S.Board)

Patents Published:

Pharmaceutical compositions of Diclofenac or Salts thereof

Publication number: 201********

Filed: May 3, 2013

Publication date: September 10, 2015

Inventors: Moinuddin Syed, Nitin Martandrao Mehetre, Rahul Sudhakar Dabre, Girish Kumar Jain

Pharmaceutical compositions of Diclofenac or Salts thereof

Publication number: 201********

Filed: May 3, 2013

Publication date: September 10, 2015

Inventors: Moinuddin Syed, Nitin Martandrao Mehetre, Rahul Sudhakar Dabre, Girish Kumar Jain

Pharmaceutical compositions of diclofenac or salts thereof

Publication number: 201********

Filed: May 3, 2013

Publication date: August 27, 2015

Applicant: WOCKHARDT LIMITED

Inventors: Moinuddin Syed, Nitin Martandrao Mehetre, Rahul Sudhakar Dabre, Girish Kumar Jain

Modified release solid oral pharmaceutical compositions of cyclobenzaprine or a salt thereof

WIPO No: WO2015150948A1

Publication Date: March 2014

Applicant: WOCKHARDT LIMITED

Inventors: Moinuddin Syed Vishal Omprakash Daga Rahul Sudhakar Dabre Girish Kumar Jain

Programmed drug delivery

WIPO No: WO2013030726A1

Publication Date: August 2011 2014

Applicant: WOCKHARDT LIMITED

Inventor: Moinuddin Syed https://patents.google.com/?inventor=Vishal+Omprakash+DAGA Ananda Haranath Uppalla Rahul Sudhakar Dabre Girish Kumar Jain

Oral Film composition comprising Levothyroxine

WIPO No: WO2021100063A1

Publication Date: August 2011 2014

Applicant: WOCKHARDT LIMITED

Inventor: Moinuddin Syed https://patents.google.com/?inventor=Vishal+Omprakash+DAGA Jack Aurora Rajendra Gawali

WO2021100063A1

Research Articles Published:

1)Real-time imaging as an emerging process analytical technology tool for monitoring of fluid bed coating process Venkata Ramana Naidu Rucha S. Deshpande Moinuddin R. Syed & Pravin S. Wakte Pharmaceutical Development and Technology 23(6):1-25

DOI:10.1080/10837450.2017.1287730

2)PAT-Based Control of Fluid Bed Coating Process Using NIR Spectroscopy to Monitor the Cellulose Coating on Pharmaceutical Pellets Venkata Ramana Naidu Rucha S. Deshpande Moinuddin R. Syed & Pravin S. Wakte. AAPS PharmSciTech 18, 2045–2054 (2017). https://doi.org/10.1208/s12249-016-0680-2

3)Endpoint determination of fluid bed coating process using real time imaging technique EyeconTM Venkata Ramana Naidu Rucha S. Deshpande Moinuddin R. Syed Pravin S. Wakte Sean Costello Emmet Hogan October 2016 Conference: 8th pan European Science Conference on Quality by Design and Process Analytical Technology Sciences

4)Fast Dispersible Tablet of Paroxetine Hydrochloride: Taste Masking and Administration in Depressed Patients Moinuddin R. SYED 1 & Jitendra B. NAIK Latin American Journal of Pharmacy 29 (5): 667-73 (2010)

5)UV Spectrophotometric method development and validation for determination of

Paroxetine hydrochloride in pharmaceutical dosage form”, Jitendra. B. Naik and

Moinuddin. R. Syed, International Journal of Pharmacy Pharml Sci., 2 (2), 43-45 (2010)6

6)Evaluation of different methods of isolation of cyanidin from syzygium cuminii, Moinuddin Syed, Avinash S Dhake, Jitendra B Naik, Seema Hashmi, Aquil R Siddiqui, Planta Activa, 2012

7)Shelf Life Assessment of Drug Product after opening Container for the first time

SH Abubakar Salam Bawazir, Fayyaz Razvi, Syed Moinuddin Rashid, Vishal Daga

International Journal of Scientific Development and Research 3 (8) (2018)

8)Development and Evaluation of Process Analytical Technology (PAT) Tool for Functional Coating Weight Gain Determination by Pellet Characteristics Measurement DAS Bawazir*, DSM Rashid, F Razvi, Z Mohammed, DS Hashmi Asian Journal of Biochemical and Pharmaceutical Research 8 (2), 33-41(2018)

Personal profile

ØNationality : Indian.

ØDate of Birth : 26/10/77

ØMarital Status : Married

ØFather’s Name : Syed Rashid

ØReligion : Islam

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