Resume Nina July

NINA SHARMA M. Pharm (Gold medalist), PhD (IIT, BHU, India), 1985 Post Graduate Diploma in Marketing Management ( CIM ,UK) 2007 Advanced Diploma in HR Management

(ABE UK) 2008

Advanced Diploma in Business Management (ABE , UK) 2009

( Top Paper Prize Award for two papers )

E Mail ID:

[email protected] , [email protected] ,[email protected]

Hand phone 09820733290, 09821011886 , Phone 9122 25797954,9122 25700453

Experienced in top level Operations of Research & Development with P &L responsibility and New Unit set up for regulated markets in reputed organizations. Professional Synopsis

An incisive professional with over 24 years of Industry experience in New Unit Set ups/Project Management/ Formulation R & D, QA Compliance, Clinical operations &, FDA Compliance, Vendor and ESP ( External Service Provider ) management for global market. In current role as Senior Director with Janssen Pharmaceutica ( J&J ) leading 10 million USD investment for set up , operation and management of new R&D and Pilot plant for development and manufacturing of products. Most recent assignments were with Novartis Healthcare Private Limited as R & D Head India – Global OTC Research & Development Lab and Pfizer as Director ( Head ) for development and Analytical s Global R&D Center for Vet Medicine . Expertise in managing entire operations with key focus on productivity, bottom line profitability by ensuring optimal utilization of resources. Result oriented record of streamlining the working SOPs for enhanced operational effectiveness. A proven track record of focused approach in building and nurturing teams for Organization effectiveness .Extensive experience in product design & development , technology transfer Food, FMCG ,Drugs ensuring compliance with Quality standards including Clinical Operations, expertise in monitoring project completion within the time/ costs/ quality schedule.

Adept at planning schedules, ensuring smooth conductance & documenting the process. Comprehensive understanding of planning & controlling commercial process. Well versed with IT Strategy , Quality Assurance/ Compliance norms, technical Writing .Have published twenty research publications including four in international journals, US and European Patent holder across the illustrious career path. Distinction of launching new products in conventional and New Drug delivery systems .An effective communicator with excellent People management/ training skills and strong analytical, problem solving & organizational abilities with proven track record of efficiently working with global partners. An enterprising leader with high professional integrity and ability to motivate personnel towards achieving organizational objectives and adhering to industry best practices.

Career Highlights Senior Director , Johnson and Johnson Global R&D Center Since July 2008 The responsibilities include set up and start up of Pharmaceutical development organization for Chem Pharm , Global NCE Pre formulation and Late development for EU and US and support emerging markets of India , China , Brazil , Mexico . •

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The under construction Pilot Plant of 22000 sq ft area is being set up to comply with USFDA , EMEA and apart from registration batches will also manufacture Clinical supply..The facility is designed for PBOEL 2 compounds but with containment and moon suit PPE it can handle 3b compounds as well. There are 50 process equipment ,32 AHU,s ,Purified water system , BMS,EMS . The capabilities are developed for solids , liquids , semisolids , and solid state characterization. The operation of Pilot Plant , Pharmaceutical development lab and Reg CMC are part of portfolio. Achievements so far include creating Road Map of Pharmaceutical Development till 2012 and integration with DRUG Product development stategy , PD Pilot Plant qualification close to completion, recruitment , training , projects transition , Vendor audits and development, Regulatory and logistics systems.

Since Sept ’05 Jan 2008 Novartis Healthcare Private Limited as Site Head India – Global OTC Research &Development Notable Deliverables

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Reporting to Global R&D Head, Switzerland. Led the effort in setting up the India Lab from Start up to operational build the team through recruitment and training , .Head count increased to 47, established functions like Product development , Analytical, QA , Regulatory-CMC, Documentation ,CSV , I T Clinical operations , Facility Management , EHS ,Purchase and administration. The Stability centre having 18 chambers can cater to all the four zones including Brazil .Use of LIMS, Empower, SAS an NDMS are fully validated and 21 CFR compliant. Clinical operations (Phase III) through CRO (Siro, Lotus, Reliance Life Sciences) in the area of Generic OTC molecules for advanced market. Studies executed by Protocol preparation , approval ,quality audits and effective relation management , periodic reporting to global Clinical operations at Nyon ( Switzerland ) Played a key role in introducing Standard procedures (283 new) to make India Lab compliant with Global Quality operations standard and obtained USFDA Registration for the Site. The standards introduced by India Site are adopted by two other global sites .Data generation as per USFDA , EMEA , ANVISA and MCA Recruitment and training of team members on technical , managerial , team building and Organization behaviour Efficiently led the Information Security and Safety Audits with successful outcome. Distinction of leading the Group Quality Audit which is a tough internal standard to meet and India is the only compliant Lab so far, US FDA registered. Conducted successful studies on major global brands like Excedrin, Vibrocil, Theraflu, and Buckleys & Benefiber and applied the Project Management tools, innovative research based on market feedback. Milestones on delivery of Projects completed on time. Global project teams technical resource on global brands like Beefier , Theraflu Established a successful R&D Centre with high productivity and GMP within short time.

April’04- August 05

Pfizer India Limited as Director

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Reported to Executive Vice President Technical India and dual reporting to Director at Sandwich Eaton.Planning and budgeting for new research center in Formulations and API , won 9 million dollar investment (first ever for the Thane Site )

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Awarded four NCE Enhancement projects in Liquids and solids from Sandwich through bidding process Liaison with Indian Regulatory Authorities for fast approvals of import of API and formulations Led the effort in establishing the Organization and formulating plans for expansion. Pivotal in establishing linkages across Pfizer, organization processes for reporting and communication, project management and control systems, and people development.

Feb99-March 2004 Colgate Palmolive India Ltd., General Functional Manager-Oral Care Notable Deliverables • •

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Reported to Vice President Technology Technical business support for driving growth in India, Pakistan, Africa and Middle East through new products launches in Oral care technology. Managed and coordinated largest Anti caries Clinical trials on Oral formulation with Triclosan and Fluoride conducted in India on 6000 children over a period of 24 months through Dentists. Managed and coordinated Multicentre Clinical trials on Whitening Oral care formulations conducted in India for Indian and Australian market. Managed and coordinated Clinical trials on formulations with different polishing agents. Managed and coordinated Clinical trials on Toothpowder and toothbrushes Effective coordination with Global Research centre for Protocol preparation , approval , servicing of sample , reporting to Global. Efficiently liasioned with Government bodies for strategic partnership on future specifications for RM and Finished products pertaining to Oral care. o Led the effort to design, develop and Re launch major flagship brands Colgate Dental cream five times, Colgate toothpowder three times and Fresh Energy Gel two variants re-launched three times each to claim back the lost market shares (approximately 900 crores business). Regained the lost market share by nine points. o Launching of Low cost formula with Cabaca brand name which resulted in increase in 7% Market share, formulation developed indigenously.

Entry to medium price segment by launching Colgate Herbal Led the efforts in the development of several innovative forms of Oral care including stripe formulations, innovative affordable oral care formulation. Initiated several cost saving projects and implemented margin improvement programs on formulations. Successfully obtained Ayurvedic classification to support pain claim for Herbal dentifrice due for launch. Conducted several training programs for management team of manufacturing locations on Quality as certified trainer. Spearheaded functions for entry into Low and medium price segments retaining the Colgate Global standards, to compete in emerging markets dominated by local players. Herbal segment through launch of Herbal toothpaste Pivotal in designing Consumer qualified products to enter new market segment. Efficiently executed Quality improvement programs for raw material across six manufacturing locations in India and Nepal. Margin improvement programs on all the major brands like Colgate Dental cream, toothpowder and Gel formulations thereby resulting in huge savings viz. common base Technology for to drive margins, new crystal structure development for Calcium carbonate, process improved for Triclosan manufacture, introduction of liquid form of Sodium lauryl sulphate, powder form of Sodium silicate, use of Natural calcium carbonate in liquid dentifrice Developed self-preservation technique for liquid dentifrice named as Gold standard by Piscataway Research center .Merit of introducing Quality standards and Guidelines in India Technology center Designing Specifications for Bureau of Indian Standards for Toothpaste, toothpowder, Sorbitol and Calcium carbonate. Filed one patent on Coated Natural Calcium Carbonate Oral Care Toothpowder Composition. Distinction of being committee member on three BIS Committees for PCD 19 for 4 years. Received Colgate YCMAD Award for innovation 4 times. o

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Sept ’97-Jan’99 Searle India Ltd., Senior Manager (Pharmaceutical Development)

Notable Deliverables Reported to Vice President Marketing o

Instrumental in developing, reformulating & launching 12 products within fourteen months. Pivotal in developing New products in area of conventional and specialized delivery system in therapeutic segment of cardiovascular, anti diabetic, gastrointestinal, anti-infective, neurological and biotechnology products.

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Dosage forms like tablets, capsules, chewable, sustained release, dry syrups, liquid orals, suspensions using resin technology and injectables.

July’94- Aug97 (Development)

Lupin Laboratories Ltd as Senior Manager

Notable Deliverables Reported to Executive Vice President Pharma •

Led the effort in launching New Products Division , by developing & launching 8 new Herbal products through a new division of ethically promoted Natural products with 50 Sales personnel .Limited Phase III Clinicals for Anxiolytic and Appetite Stimulant formulation managed and coordinated through Clininvent. Claim support Clinicals on Ayurvedic Uterine tonic (U-Sedate) conducted at KEM Hospital Mumbai and Pune. Launched products like natural appetite stimulant, oral care, arthritis, rejuvenation, laxatives and digestive

Dec’91-June ’94 Ranbaxy Laboratories Ltd., as Product Development Manager Notable Deliverables ,Successfully developed and launched several conventional and specialty dosage forms as tablets, liquid oral, injectables, creams and led the team of product development scientists .Pivotal in supporting export market through regulatory submissions, product development and launch in the designated countries. March’85-Nov ’91 Procter & Gamble India Ltd., as Research a nd Development Manager Efficiently developed and launched indigenously developed Herbal products in Food an OTC Category in candy and syrup base. Aug 80-Dec ’84 Lecturer Nov ’78-July ’80

Indian Institute of Technology, Benares Hindu University as

Hamdard College of Pharmacy, University of Delhi as Lecturer

Affiliations •

Indian Pharmaceutical Congress – Life Member and chairperson of Subcommittee 1992 Controlled Release Soc Indian chapter Bureau of Indian Standards Committee member UGC Junior Fellowship ,Charted Institute of Marketing, UK ,Associate of Business Executives UK

Personal Details Address: 1104, Sovereign, Hiranandani Gardens, Powai, Mumbai 400 076, Contact 9820733290