DILIP PATEL

*** *.************* ****,***.**

Piscataway, NJ-08854

Cell-732-***-****

E-mail: adczjo@r.postjobfree.com

SKILLS

Process Improvement, Design and Multi step-synthesis of Organic Intermediates & Active Pharmaceutical Ingredients.

Work on antibiotic pilot fermenter upstream and also in downstream.

Look after contract manufacturing in US & India

Scale up in pilot plant from 0.2 kg to 5 kg. Also scale up to commercialize production.

Making SOP’s at Laboratory scale and also make changes during scale up to pilot and manufacturing level

Isolation of impurities & purification of small volume API by semi preparative HPLC.

Purification of compound by Column-chromatography, Crystallization, Extraction and Fractional Distillation

High Vacuum & Fractional distillation and high pressure reactions using Pd/C, Pt/C, Pt oxide & Rani-nickel

Knowledge of drying by Lyophilization, Vacuum, Fluid bed dryer, Tray dryer etc.

Literature survey study and finalizing the route of synthesis

Auditing of technical document.

Some experience in Project Management.

Familiarity with IR, HPLC, GC, KF-Titrator, Dissolution, M.P. apparatus & other lab. Instruments. Preparation of reagents required for testing.

Experience in Mixing, Formulation of Chemicals as per batch records

Pharmaceutical experience in a GMP & GLP environment.

Basic computer knowledge.

As a educational background of Microbiology & Biochemistry therefore, I am well aware of Biological terminology.

Works in aseptic area.

PROFESSIONAL EXPERIENCE

Self Employed, Piscataway NJ– 07/19 – Present

Consultant

Literature survey, study and finalizing the route of synthesis.

Contract R&D and Contract Manufacturing of API and Fine Chemicals

Perform Process validation at R&D stage, pilot scale.

Helping in QC for method development

Biospectra, Bangor PA – 02/18 -10/18

R&D Manager

Literature survey, study and finalizing the route of synthesis

Synthesize Biological buffers, Detergents, Coupling agents &API’s

Recrystallizing Biological Buffers and fine chemicals for molecular biological use.

Perform process validation at R&D, pilot scale and process control under GLP environment.

Help marketing department for product profitability and advice can be manufactured in our facility.

Self Employed, Piscataway NJ– 08/16 – 02/18

Consultant

Literature survey, study and finalizing the route of synthesis.

Contract R&D and Contract Manufacturing of API and Fine Chemicals

Perform Process validation at R&D stage, pilot scale.

Helping in QC for method development

Apogee Pharma, Ford (NJ) USA 08/08 – 08/16

Director

Developed Vit. D derivatives and Prostaglandins.

API development and validation of synthetic route at R&D and helps writing SOP

Look after contract manufacturing of API, Intermediate & contract R&D

Scale up & Technology transfer from R&D to pilot plant

Process control by HPLC, TLC, pH Perform process validation at R&D, pilot scale and process control under GLP environment

Analyzing analytical data

Literature survey, study and finalizing the route of synthesis.

A Z Electronics Materials, Branchburg (NJ) USA 07/06-05/08

Research Chemist

Scale up & Technology Transfer from R&D to Pilot Plant.

Manufacturing of Polymer at Pilot plant

Formulation of Polymers Solutions.

Trouble-Shooting during Scale-up.

Process control using modern analytical instruments.

Analyzing the analytical data.

Assist in Documentation,validation documents,product profile, batch review documents etc.

Apicore LLC Somerset (NJ) USA 06/05-07/06

Research Scientist

Active Pharmaceutical Ingredient development and validation of synthetic routes.

Scale up & Technology Transfer from R&D to Pilot Plant.

Trouble-Shooting during Scale-up.

Familiarity with modern analytical technique for compound purification & characterization.

Analyzing the analytical data.

Auditing of Documentation.

Literature survey, study and finalizing the route of synthesis.

Pentachem, Baroda (Gujarat) India 04/02-03/05

Partner.

Active Pharmaceutical Ingredient development and validation of synthetic routes.

Scale up process on pilot plant and manufacturing scale up.

Preparations of technical document.

Work on HPLC, GC, KF & also hands on experience of TLC.

Literature survey.

Auditing of technical document.

Macrolide Antibiotics Ltd. Baroda (Gujarat) India 06/93-03/02

Technical Director..

Active Pharmaceutical Ingredient development and validation of synthetic routes. [Azithromycin,Clarithromycin, Roxithromycin,Raloxifene HCL,Simvastatin]

Scale up process on pilot plant and manufacturing scale up.

Preparations of technical document.

Work on HPLC, GC, Dissolution, Spectrophotometer, IR, KF titrator, M.P. apparatus etc and hands on experience of TLC.

Literature survey.

Auditing of technical document

Developed anadasetrondione by fermentation up to pilot plant.

Trident Chemical, Nadiad (Gujarat) India 03/88- 09/95

Partner.

Production of Erythromycin Salts & Roxythromycin.

Quality Control Management.

Active Pharmaceutical Ingredient development and validation of synthetic routes.

Scale up process on pilot plant and manufacturing scale up.

Preparations of technical document.

Work on GC, KF titrator, M.P. apparatus, IR etc and hands on experience of TLC.

Literature survey.

Auditing of technical document.

Alembic Chemical Works Ltd. Baroda (Gujarat) India 03/78-03/88

Sr.Microbiologist./ Chemist

Microbiological Assay of Antibiotics.

Sterility of Bulk Antibiotics in aseptic area

Monitoring of Aseptic area area.

Toxicity test on Albino mice.

Microbiological Analytical method development.

Literature survey for New Product. Development

Process improvement of product.

Auditing of technical document.

Work on Erythromycin and Kanamycin pilot fermentor plant and also in downstream.

Making Kanamycin Sulphate salt and drying by Lyophilization method.

EDUCATION

Gujarat University, Ahemdabad, (Gujarat) India.

Bachelor of Science degree in Microbiology and Chemistry (April, 1977).

M.S. University, Baroda,(Gujarat) India.

Master of Science in Biochemistry (June 1985).

CERTIFICATION

Bhavan’s School Of Management Baroda, (Gujarat) India.

Diploma in Business Management (March, 1980).

LICENCES

Approved by FDA authority Gujarat State (India) as a Technical person in Microbiology, chemical and instrumentation for Pharmaceutical testing.

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