Development Manager

Dhrub Tripathi

M.No. 941-***-****, 965*******

Email: *************@*******.***, *************@*****.***

Objective

To work in an Environment where my educational knowledge and skills can be applied in the filled of pharmaceuticals (R&D and Production) as Formulation Development, Analytical Development, Stability Study, Technology Transfer with documentation and Controlled of Quality Assurance for fulfilment of organization goals as well as personal for to be part of successful corporate family.

Area of Expertise:

•Quality by Design & Process Analytical Technology.

•Design of Product with QTPP & CQA.

•Specializing of New Drug Delivery System.

•Pre-formulation studies with Physicochemical Properties.

•Formulation Development of Various Dosage Forms.

•Formulation development of Ophthalmic Preparation

•Formulation development of various small and large Volume Parenteral

•Formulation development of oral solid & liquid dosage forms.

•Formulation development of Various Topical Preparation.

•Stability Study with Regulatory Market.

•Patent search, analysis and interpretation for Pharmaceuticals Products.

•Reformulation, cost reduction of various pharmaceuticals products.

•Qualitative and Quantitative Evaluation of Product.

•Technology Transfer Plan, Technology Transfer & Process Validation.

•Process optimisation in shop-floor Trouble Shooting.

•Documentation Regulated market as US-FDA, MHRA, MCC and Domestic Market as per DCGI.

Job Qualification :

Total Experience for 20 years 09 Months to pharmaceuticals Research & Development and Production Department.

Academic Profile

Post-Graduation:

Master of Science

University: S.S.J.M. University Kanpur

Dissertation Title: Organic Chemistry

Graduation:

Bachelor of Science

University: Kanpur University Kanpur

Dissertation Title: Chemistry, Botany

Technical Qualification:

Approved with Tablets and External Semi-solid (ointment) dosage to Food and Drugs Administration Bhopal (M.P.)

Card Ref. No.: MC – 1458

Present Professional Profile

Organization: Vee Execl Drugs & Pharmaceuticals Pvt. Ltd. –Gr. Noida

(Certified Manufacturing Pharmaceuticals Units with Research & Development)

Field: - Pharmaceuticals Research & Development according to Quality by Development with Process Analytical Technology, to be follow Formulation Development, Analytical Development, Stability Study, Pilot Plant, and Production Plant as per Regulatory guide.

Status: Manager of R&D and Production (E-Marketing)

Working Tenure: Nov. 2015 to till time

Responsibility:

*Demonstrated Pharmaceuticals Plant as EU - GMP.

* Research and development lab set up as per cGMP & GLP.

*R&D Center recognized from DSIR, after recognized unit, take to government benefits.

*Literature survey (Using Journals and online search) Patent Search using Sci-Finder, STN and various Patent databases.

*Development of Novel dosage to following technologies: matrix & diffusion, controlled drug release, nanopartical method, micronization & micro encapsulation, osmotic delivery, ready to used, preservative free dosage, pelletization and extrusion spheranization.

*Development of various types of solid oral dosage forms such as Tablets, Liquid, Orals and suspensions, capsules etc. Lyophilized and Liquid Injections for various Markets.

*Study Stability of the Dosage form (in compliance with EMEA, FDA, ICH & VICH Guidelines), Shelf life Calculation.

*Technology Transfer to Production.

*Preparation of Process Validation Protocols and validating the processes and supporting production team in validating equipments.

*Product Development Report generate with stability data.

*Preparation of Dossiers for new drug application.

*Documentation including Preparation of Product manuals, MFR & MPR Specifications and Dossiers as per specific required.

*Co-ordination with Analytical department for developing of FPS, RMS, and STP.

*Facsimile, Artwork and Pack Insert preparation.

*Co-ordination with QC, Production, Packing, Clinical & Marketing divisions.

*Calibration of various equipments in the area concerned.

*Identification of different raw materials/ machinery required and preparing Standard operating procedure for various equipments.

*Sample Procurement and Correspondence with exports for necessary.

Previous Professional Profile

1)Organization: Akums Drugs & Pharmaceuticals Pvt. Ltd. –Haridwar (UK)

(A Multicrore WHO-GMP & ISO 9002 Certified Manufacturing Pharmaceuticals Units with Research and Development)

Field: Formulation Development for Pharmaceuticals Solid and Liquid for Orals doses, Parental (small & large) Liquid and Semisolid for External Dose.

Status: Manager of Formulation Development

Working Tenure: July 2011 to Nov. 2015

Achievements:

*Formulation Development of various antibiotic & antimicrobial products i.e. Aceclofenac Injection 150mg water base and may be also LVP .

*Formulation Development of various Multi Vitamins, Minerals with amino acid injection & Lyophilized Products.

*Development of solid & liquid Oral dosage, Injections, Ointments, Infusions, Eye and Ear Drops as Regulated market.

* Technology Transfer & Trouble Shooting.

2) Organization: Pfizer & RFCL Ltd., - New Delhi

(A Multicrore WHO & ISO 9002 Certified Research and Development Pharmaceuticals Units with Recognized DSIR)

Field : Formulation Development for Pharmaceuticals Solid and Liquid for Orals doses, Parental (small & large) Liquid and Semisolid for External Dose.

Status: Manager of Formulation & Development

Working Tenure: Feb 2007 to July 2011

Achievements :

* Research and development lab set up as per cGMP.

*R&D Center recognized from DSIR, take to government benefits.

*Lunched various antibiotic Formulation & Tech transfer as IIIrd party with dossier:

•Florfenicol Injection 30%.

•Enrofloxacin Injection 20% Long acting, 30% under development

•Enrofloxacin & Ketoprofen Injection.

•Enrofloxacin + Bromhexine Oral liquid.

• Various Calcium & Phosphorus with Vitamins and Protein tonics for Animals Feed.

*Reduced the cost of existing formulations by using alternative materials &Processes.

*Improved the Quality of existing formulation as per international regulatory requirements.

*Successfully completed General course on Intellectual Property from world Intellectual property Organization.

3) Organization: PROMED RESERCH CENTER, GURGOAN

(A Multicrore WHO & ISO 9002 Certified Research Center Pharmaceuticals Units).

Field : Formulation for Pharmaceuticals Solid and Liquid for Orals doses External Liquid and Semisolid for External Dose.

Status: Senior Research Scientist

Working Tenure: Jun 2005 to Feb 2007

Achievements:

*Developed various Formulation & Tech transfer as IIIrd party with dossier.

•Cycloserine Capsule 250 & 500mg

•Levofloxacin Tabs (250 & 500mg) &Infusion,

•Budisonide nebulizer develops as Solution.

•Cefepime, Ceftrixone, Cefoparazone, Salbctum for Injection.

*Formulation Development of non-oncology products e.g. CVS acting drugs, antibiotics, antimicrobial and antifungal drugs etc.

* Development solid & liquid dosage including, Tablets, Capsule and Dry Injections, Infusions, Eye and Ear Drops.

*Development & Documentation for CIS & ROW Markets.

4) Organization: Plethico Pharmaceutical Ltd. – INDORE

(Leading Organization in Pharmaceutical Manufacturer of Tablets, Capsules, Liquid, Dry Syrup and Injection Certified Manufacturing Pharmaceutical Unit with USFDA & MHRA)

Field: Formulation for Pharmaceuticals, Solid and Liquid for Orals Doses, External Liquid and Semisolid for External Uses

Status: Head of Tablets, Capsule and F&D

Working Tenure: April 2002 to May 2005

Responsibility:

Production planning and target achievement

To train workmen for manufacturing processes and machine handing.

Maintain of all manufacturing operation as per cGMP Co-ordination with Engineering Dept. regarding.

Maintain the record as per cGMP & WHO rules.

Tackle the workers and sub-ordinate problems at floor level smooth for smooth operation of production activities.

5) Organization: Pure Pharmaceutical Ltd. Indore

(Leading Organization in Pharmaceutical Manufacturer of Tablets, Capsules, Liquid, Dry Syrup and Injection Certified Manufacturing Pharmaceutical Unit)

Field: Formulation for Pharmaceutical, Solid and Liquid for Orals Doses, External Liquid and Semisolid for External Doses.

Status: Production Chemist for Tablets, Capsules, Liquids and Dry Syrup.

Working Tenure: Dec. 1997 to April 2002

Responsibility:

To look after all related Production matter of management Production Planning Decide new Production policy to increasing Production.

6) Organization: DUJOHN LABORATRIES LTD. INDORE

(Leading Organization in Pharmaceutical Manufacturer of Tablets, Capsules, Ointments, Liquids, Dry Syrup and Injection Certified Manufacturing Pharmaceutical Unit)

Field: Formulation for Pharmaceuticals, Solid and Liquid for Orals Doses External Liquid and Semisolid for External Doses

Status: Assistant Production Chemist for Tablets, Capsules, Liquids and Ointments.

Working Tenure: August 1995 to December 1997

Responsibility:

Working with Tablet Process, Compression, Coating for Sugar & Film (Aqueous & Non-aqueous) Capsule Process, Ointment Production and Packing Control.

Production Knowledge

Responsible for selection, design qualification, capacity attributes, handling feasibility, GMP aspects of various critical processing equipments namely Rapid Mixer granulators, Fluid Bed Driers, Fluid Bed Processors, Compression machines, Roll Compactors, Auto coaters, powder filling machines, Capsule filling machines, Extruder, Spherodizer, Centrifugal granulator and Packaging line etc.

Computer Skills : Fundamental, MS word, Excel, Power Point and Internet

Personal Details

Name : Dhrub Tripathi

Father’s Name : Shri R. K. Tripathi

Permanent & Present : F - 198, Jalvayu Vihar, Plot No.–8, Pocket – 4,

Address Greater Noida - 201318

Mobil No. 941-***-****, 965*******

Date of Birth : March 20th 1971.

Sex : Male

Marital Status : Married

Language Known : English & Hindi

Date

Place :

Yours Faithfully

(Dhrub Tripathi)

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