Manager Plant

NITIN N PATEL

**N Reading road,

EDISON, NJ -****7

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

************@*****.**.**

Mobile No: 732-***-****

Highlights:

Experience in Pharmaceutical industries including Custom research organization.

Experience in multistep synthesis using various synthetic methodologies.

Work on MK-4827 for Merck.

I have done certified course of HPLC analysis .

Experience in characterization of organic compounds using TLC,HPLC, LCMS, 1HNMR, IR.

Experienced in handling moisture sensitive reactions.

Knowledge of Chemdraw, Chemsketch, MS-Office.

Standardization, Optimization and scale up of reactions as per the client requirement.

Ability to work in group as well as independent.

Excellent communication skill, high order of discipline and positive attitude.

Educational Qualification:

Bachelor of Science – Chemistry (3.5 GPA),

March-1983 Gujarat University Ahmadabad India.

Professional Experience:

Production Supervisor

At Guardian Drug company, Dayton, NJ, USA. (March-2016 to Nov-2016)

To do planning and supervise manufacture of liquid department. Carry out formulation process of liquid.

Senior Research Associate (Feb. 2005 – June 2015)

At - Dishman pharmaceuticals & chemicals LTD – Ahmedabad - India.

To carry out process development for manufacture of fine chemicals and Active Pharmaceutical Ingredient of therapeutic categories like analgesic, antibacterial, Antihypertensive and anti-allergic. last project for Octenidine HCL, Improve process & yield (35-40%) by reducing unit operations & Utility.

Job Responsibility:

To carry out literature search with scientific department as per assign project.

To select the synthetic route as per literature.

Forward the route to Intellectual Property Rights (IPR) department for approval.

Procurement of Raw Materials for Laboratory work.

Design the Standard Operating Procedure for Process Development.

Suggest initial analytical method development for in – process Quality Control testing.

To prepare the specification of products with the help of Analytical Development Department.

After optimization of process development in lab, prepare Product Development Report .

To prepare detail manufacturing instructions provide to production department and Quality Assurance Department to make Batch Manufacturing Record (BMR).

Take validation Batches in Pilot plant and keep the samples for stability study.

Successfully carry out Technology Transfer to Production department after completion of Pilot validation Batches.

Troubleshooting the other exiting Manufacturing process for cost reduction, yield improvement as per customer requirement.

Assistant Plant Manager (Dec. 2001 – Feb. 2005)

At Halcyon Lab Pvt Ltd. Ta Naroda GIDC, Ahmedabad – India.

To support supervisor in organizing and planning manufacture of organic chemicals for pharmaceutical industrial use.

Production Manager (Jan. 1992 – Nov. 2001)

At SRC Pvt Ltd. At changodar, Ahmadabad – India.

To do planning and supervise manufacture of organic chemical for pharmaceutical industrial use.

Production Officer + (Oct. 1989 – Jan 1991)

At M.J. International at Ankleshwar – India

Responsible for production activity of active pharmaceutical ingredient of therapeutic category; antibacterial, cardiovascular.

Production chemist (June 1985 – Sept. 1989)

At Devina Pharmaceuticals at Nandasari GIDC Baroda – India.

To assist plant manager in routine production activity of organic chemicals useful in pharmaceutical industries.

Additional Info on R&D Experience

I have research experience in the field of synthesis following active pharmaceutical ingredient (API).

Products handled in R&D, PILOT PLANT

Name of active pharmaceutical ingredient

Therapeutic categories

Atorvastatin calcium E.P (crystalline –form-I By Catalyst method)

Anti hyperlipoproteinmic

Anastrozole U.S.P

Anti neoplastic

Thioridazine U.S.P/ E.P

Psychotropic drug

Topiramate U.S.P stable at 25-30 C

Anti convulsant

Succinycholine chloride E.P/ US.P

Muscle relaxant

Glipizide E.P/U.S.P

Anti diabetic

Indapamide E.P/U.S.P

Antihypertensive, Diuretic

Clobetasol propionate I.P

Steroid

Fluticasone propionate E.P

Anti allergic

Ketoconazole. U.S.P

Anti Fungal

Erythromycin Estolate I.P

Antibacterial

Dexchlorpheniramine Maleate U.S.P

Antihistamine

Menadione sodium bisulphate I.P

Vitamin (prothrombogenic)

Octenidine Hydrochloride & Intermediate- 4-octylamino pyridine

Antiseptic

Nifedipine U.S.P

Anti angina

Bisacodyl E.P

Laxative

Sodium Picosulphate I.P

Laxative

Clopidogrel bisulphate U.S.P

Anti thrombotic

Strontium Ranelate

Osteoporosis

Reference available upon request only.

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