FULL RESUME

DR. NINA SHARMA

M.Pharm (Gold medalist)

PhD (Indian Institute of Technology, 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 Global Award for two papers)

FORMULATIONS EXPERT

Experienced in top level R&D Operations of Formulation Development, Global Portfolio and ­Resource management with successful  projects completion and Formulation launches   in   various therapeutic categories, for OTC, ANDA and 505(b) (2), NCE and Biosimilars in reputed organizations with repeated track record of achievement

High level Formulation Development skill for LVP.SVP.Tablets, Capsules,Dry Syrup,Liquids, Semisolids for domestic and International markets, QA and Regulatory for USFDA , MCA and semi-regulated markets

Formulation development ,Technology transfer and Production operations ,Quality and compliance expert with track record of successful new products launches  , portfolio expansion, Claims substantiation and Regulatory support, Tech transfer and supply chain transition management ,Project and team leadership to drive successful product launches within time and budget.

In  recent   roles  as Senior Director with Johnson and Johnson ( J&J )  have led  10 million USD  Formulation R &D project  for Early developmentand Late Development ANDA ,manufacturing of clinical supplies  for advanced market  and Integrated drug product development for Emerging markets of China ,Korea, Taiwan and Mexico; Director Technical and Scientific Affairs with Teva Pharma  Assignments with Novartis Healthcare Private Limited as R & D Head India – Global Research & Development Lab for OTC and Pfizer as Director (Head) for Formulation development Global R&D Center for Vet Medicine   were successful   projects in leadership position of Formulation R&D. Expertise in FMCG Sector as Head of Oral care Technology in India Global Formulation R&D Center, Procter and Gamble as R&D Manager Healthcare and Generics in Ranbaxy, Lupin and Searle.

Have published twenty research publications including four in international journals, US andEuropeanPatent holder across the illustrious career path.

Distinction of launching new products in conventional dosage forms, solids, liquids, sterile and semisolids and New Drug delivery systems covering full span of therapeutic area for infectious, psychiatry, cardiology, virology and biotechnology, pain and HIV, well versed with NDDS and Containment strategies.

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.

CAREER HIGHLIGHTS

July 2015 to Present: Managing Director Shamisha Resources Management, Ahmedabad and Mumbai

WEBSITE……http://www.shamisha.in/

Sept 2013 to July 2015– Director Technical Services and Production operation for   Teva Pharma ( Procter &Gamble Teva Joint Venture PGT Healthcare )  , leading a team of 18 Managers /supervisors and Production staff of about 430 by end of 2014, handling commercialization of green field project of 600 crores.

Jan 2012 onwards Gresen Lehmann Group (GLG Singapore) consultant –successfully completed consultancy for Mckinsey, BCG on Pharmaceutical Development

July 2011 to Sep 2011 Senior VP Avesthagen Limited

July 2010 to July 2011 Senior Director Pharmaceutical Development and July 2008 to Feb   2010 Global Formulation   R&D Center at Johnson and Johnson

The responsibilities included 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 .

Asia Drug product development strategy and capability calculations for three Sites, project allocation and transition plan, global SOP, s and processes.

Creating   Road Map of Pharmaceutical Development till 2012 and integration

Since Sept 2005 Jan 2008 Novartis Healthcare Private Limited as Formulation R&D Head India – Global OTC Research &Development

Notable Deliverables

• 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 and fully validated 21 CFR compliant systems.
• Product design and submissions for ANDA in advanced market domain.
• Clinical operations (Phase III) through CRO (Siro, Lotus, and 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
• 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.
• Planning and control of Revenue and Capital budget for India Site

HOLDS THE MERIT OF

• US FDA Registration ,Twenty eight Pharmaceutical development and Stability testing projects in the area  Conventional Solids , Liquids semi solids and NDDS , Patches
• Clinical operations, Technical writing, CMC Head count expansions within short time of lab operations.

Instrumental in collaborating with other Global Sites and local management to drive superior results.

• 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 Benefiber, Theraflu
• Established a successful R&D Centre with high productivity and GMP within short time.

Apr 2004- August 20 05           Pfizer India Limited as Director

• Planning and budgeting  for new research center in Formulations and API , won 9 million dollar investment (first ever for the Thane Site )
• Awarded four NCE Enhancement projects in Liquids and solids from Sandwich through bidding process for US and Europe market.
• Formed the core team of R&D Scientists and Managers
• Conducted early development studies for NCE molecules, coordinated pharmacokinetic studies on anthelmentics, Doramectin pour on, Selamectin with Praziquantel spot on formulations.
• Technical 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.

 Feb1999-March 2004        Colgate Palmolive India Ltd., General Manager-Oral Care

 Notable Deliverables

• 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.
• 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 point
• Launching of Low cost formula with Cibaca 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
• Participated in designing new plant for toothpaste manufacture
• 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 four times
• Nominated  team members and direct subordinates to win the award 19 times.

Sept ’1997-Jan1999   Searle India Ltd., Senior Manager (Pharmaceutical Development)

Notable Deliverables

·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.
• Dosage forms like tablets, capsules, chewable, sustained release, dry syrups, liquid orals, suspensions using resin technology and injectables.
• Played a key role in setting up a new department for international regulatory submissions, dossiers submitted for twenty molecules to contribute to export business.

July 1994 – Aug 1997   Lupin Laboratories Ltd as Senior Manager (Development)

Notable Deliverables

• 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
• Periodontical Clinicals conducted and managed in Governmental dental College Mumbai
• 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
• Developed personal care products for export market, shampoos, hair oils, oral rinses, anti ageing cream all herbal/natural in nature
• Successfully introduced bulk actives for exports, filed international patent on novel process for extraction of Hydroxyl Citric Acid from Garcinia.

Dec1991-June 1994 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 for India, Semi regulated markets of CIS , Indonesia , Malyasia and also Europe.
• Managed and coordinated several BA/BE Studies for anti-infective in Ranbaxy and also Therapeutic Drug Monitoring Lab Mumbai.
• Pivotal in supporting export market through regulatory submissions, product development and launch in the designated countries.
• Significantly contributed in documentation for MCA approval.

March 1985-Nov 1991, Procter & Gamble India Ltd., as Research and Development Manager

• Efficiently developed and launched indigenously developed Herbal products in OTC Category in

candy and syrup base

• Actively participated in Clinical trials for OTC products (cough syrup)
• Joining position Research Executive, promoted to Asstt. Manager, further promoted to Manager

Aug 80 -Dec ’84       Indian Institute of Technology, Benares Hindu University as Lecturer

Nov ’78-July ’80       Hamdard College of Pharmacy, University of Delhi as Lecturer

Academic Distinctions

Received Best Girl Student award in High School, University

Merit scholarship National Scholarship CSIR Scholarship –not availed

Memberships : Beureu of Indian Standards 2000-2004, IPA Life Member, CIM Member

Contact details  nina1sharma@gmail.com, 9820733290,9974672915,07940321865,02225797954

Address

Shamisha Resource Management  331-332 Sobo Centre South Bopal Ahmedabad

Ahmedabad  A92 Shaligram 3 Prahladnagar Ahmedabad

Mumbai  1104, Sovereign Hiranandani Gardens Powai Mumbai 400076

////////////Shamisha Resource Managment, Experts in Recruitment, Pharmaceutical ,  FMCG Consulting, NINA SHARMA