S. VISHNU VARDHAN

General Manager API - Research & Development

Mobile No – +91-800-***-**** ac8nda@r.postjobfree.com

Core Strengths

Dynamic, entrepreneurial pharmaceutical professional

Designed and developed numerous non-infringing process for significant products/NCEs.

Successful in Technology Transfer of manufacturing process to outside Facilities/Laboratories.

Highly trained professional utilizing state-of the art technologies

Product Development, GENERIC, RX & OTC from concept to launch.

Expense control API process performed/planned independently

Generating multi-disciplinary teams for manufacturing/production in cGMP

Project Management and its execution.

Analysis of pharmaceutical finished products, raw materials and its related substances as per cGMP

Regulatory compliance & quality system management

Team Leader of 10+ executives to bring up combination of strong leadership skills and proved ability to motivate team workers

Professional experience

M/s. Vamsi Pharma Pvt Ltd, Hyderabad Mar’17 – Till date

General Manager – New Product Development

Identifying areas of bottlenecks & breakdown and non-conforming products

Developed non-infringing process for Tetraene acetate (3TR) intermediate, a key intermediate of many Corticosteroids. (~16 APIs)

Filed an Indian Provisional application of Tetraene acetate, a key intermediate of corticosteroids.

Improved process for the preparation of 16α-Hydroxy prednisolone, a key intermediate for the preparation of Budesonide.

Developed process for the preparation of Mometasone Furoate, Halobetasole & Ciclesonide.

Troubleshooting the root causes of procedural problems

New Process development for different polymorphic forms

NOBEL İLAÇ SAN. VE TİC. A.Ş., TURKEY Oct’13 – Mar’17

Synthesis Specialist and Technology Transfer Team leader

Developed non-infringing process for Pirfenidone and filed a Turkish patent application.

Synthesized novel molecules for Alzheimer’s disease.

Developed processes for Proton-pump inhibitors (PPIs), by irreversibly blocking the hydrogen/potassium adenosine triphosphatase enzyme system of the gastric parietal cells.

Developed new process for the preparation of Nilotinib HCl anhydrous polymorph.

MSN, Hyderabad Jul’10 – Oct’13

Manager – New Product Development

Non-infringing process for the preparation of Ambrisentan

Improved process for the preparation of Posaconazole with ICH quality.

Developed processes for Proton-pump inhibitors (PPIs), by irreversibly blocking the hydrogen/potassium adenosine triphosphatase enzyme system of the gastric parietal cells.

Successfully developed novel process for the preparation of Posaconazole amorphous polymorph.

Ability proved in handling team size of 10 members

M/s Torrent Research Center, Ahmedabad, Gujrat Jun’09 - May’10

Manager (Vendor Audits & In-house API Development) - Corporate Quality Assurance Department

Qualification of internal and out sourced APIs via audits.

Preparation of SOPs and their Quality requirements for US & EU

Internal/ External QA audits

Regulatory compliance & quality system management

Vendor Qualifications and their approval

Dr. Reddy's Laboratories Ltd., Hyderabad Jun’96 – Jun’09

Deputy Manager - API R&D

Improvised process patent for the preparation of Palonosetron Hydrochloride

Process for Darifenacin HBr for its regulated market.

Non-infringing process Divalproex Sodium that also resulted in reduction of product cost

Process for Ezetimibe for its less regulated market with increased yields to reduce the cost of the product

Process for Ezetimibe for its regulated markets by removing column chromatography technique with excellent yield and purity.

Non-infringing process for Sumatriptan Succinate with DMF approval

Reduced the cost of Cetirizine 2HCl and Fexofenadine HCl for their less regulated markets

Non-infringing process for Ondansetran HCl with DMF approval

Patents

Indian patent application for improved process for the preparation of Clevidipine Butyrate

Patent for the improvised process for the preparation of Posaconazole

Novel polymorphic patent for Vilazodone HCl

Improvisation of process patents for the preparation of Ezetimibe (US 2007/0049748 A1) and Darifenacin Hydro Bromide (WO 2008/100651 A2)

Prepared novel polymorphs for Cetirizine 2HCl with the patent no. WO 03/104212 A1 for its novel amorphous form and Ezetimibe with the patent no. WO 05/062897 A2 for its novel amorphous as well as crystalline forms

Academic profile

PG Diploma in Patent Laws from NALSAR School of Law, Hyderabad in 2006 with 65.3%

M Sc. (Chemistry) from JNT University in 2002 with 75.3%

B Ed. (Math, Physical Sciences) from S K University in 1992 with 70.0%

B Sc. (Math, Physics, Chemistry) from S V University in 1991 with 68.0%

Know-How

Expertise in handling reactions such as reduction, hydrogenation, esterification, acylation, mesylation, grignard reactions, chiral synthesis, oxidation, cyanation, bromination, ether cleavage, cyclization, different types of protection reactions and their de-protection, resolution reactions among others

High-pressure autoclaves and various distillation facilities

Noble metal based catalyst reactions

Analytical techniques and use of IR, NMR, Mass and XRD spectrograph, MC, assays, specific rotation and TLC techniques besides others

Analysis and method development of Products, Raw materials and its related impurities(cGMP).

Products developed

API’S:

Naproxen,

Ranitidine HCl,

Famotidine,

Sildinofil Citrate,

Sulindac, Carvedilol,

Sumatriptan Succinate,

Ezetimibe,

Fexofenadine HCl,

Cetirizine 2HCl,

Darifenacin HBr,

Omeprazole,

Esomeprazole,

Divalproex Sodium,

Palonosetron HCl.

Clevidipine butyrate,

Ambrisentan,

Posaconazole,

Pantoprazole,

Vilazodone HCl,

Teriflunomide,

Bepotastine besilate,

Axitinib,

Dasatinib,

Flupentixol. 2HCl,

Vildagliptin,

Solifenacin Succinate,

Nilotinib HCl,

Pirfenidone,

Sorafenib tosylate,

Rabeprazole,

Lansoprazole,

Dexlansoprazole,

Fenoterol,

Ciclesonide,

Arformoterol,

Mometasone Furoate

Intermediates:

Cyclopropane Dicarboxylic acid

16α-Hydroxy Prednisolone

16α-Methyl epoxide

Tetraene acetate(3TR)

Personal details

Date of Birth - 28th July 1971.

Language Known -English, Hindi, Telugu, Tamil, German and Turkish

Address for communication- Flat #501, Shree Venkat Residency H-No:21/A, B.K. Guda, S.R. Nagar, Hyderabad - 500038.

Ref: Sethu Sunkara, 7 Oblate Cresent, Brampton, ON, L6YOK2, CANADA.

Contact this candidate