RAJESH PANDYA Canadian Citizen Res: 513-***-****

M.Sc. (Medical Microbiology) M.B.A Marketing Cell (305) 562- 7991

**** *** ******** ****, **********, Ohio, 45242 Email:abnflg@r.postjobfree.com

PROFILE

An analytical, results oriented manager with a proven track record in Research and development,

production, of Human & Veterinary pharmaceuticals, for generics and branded products. Possess diversified

international experience of US FDA, European Union, African and Asian Countries. A team Builder and

motivator with strong interpersonal, Communication and leadership skills. Strong knowledge of in

fundamental areas which apply to Oral / Sterile product drug delivery: e.g., solution chemistry, surface

chemistry/disperse systems, physical chemistry/thermodynamics, and solid state properties. Capable of

developing and applying new technologies independently, Demonstrates the ability to provide scientific

input and make decisions to resolve problems with minimal supervision.

EXPERIENCE

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Patheon Pharmaceuticals Inc. Cincinnati, OH August 2007- August 2009

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Sr. Scientist

Developing Pharmaceuticals formulations of NCE for top tier companies including CTM batches and

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commercial production, Managing contract manufacturing relationships for Clients (Schering Plough,

Watson, Nicox, Gilead, Astra Zeneca, Idenix, Metabasis, Intekrin, Novo Nordisk, Wyeth, GSK,

Cephalon, McNeil, Welichem Bio Tech)

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Participated in Management meeting for budget and Capitol requirement, managed buying and

installing machineries for USD 2.0 Million,

Dosage forms Liquid filled Hard Gelatin Capsules. Semi solids,Creams / Gels / Ointments.

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Managing team of 8 Scientists, 28 technicians, 29 rooms in GMP Area, 3 Formulation Labs and

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Separate Warehouse for Pharmaceutical development services along with all utility maintenance.

On going 18 projects (137 experiments, 48 feasibility batches, 91 CTM batches, in 2009)

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Swiss Caps USA Inc. Miami October 2005 – August 2007

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Process Development Manager

Conducting preformulation studies, and Optimizing Formulation, Trouble shooting of process related

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problems and creating technology transfer for solid dosage form capsules, tablets and soft gels for

Pharmaceuticals and Nutraceuticals Products quality improvements.

Suggested new formulation development techniques to clients and got approval for submission to

FDA.USA developed 10 Formulations. (Projects: Ibuprofen K+ salt, Docusate Sodium, Polycosanol,

Methoxsalen, Methyl testosterone, Prednisolone, Ergocalciferol, Dronabinol, Co Q 10, Royal Jelly,

Hoodia Ext, Green Tea, Omega 3,6,9 and Vegagel -Vegetarian Soft gel)

Pharmaceutics International Inc. Baltimore September 2004- October 2005

Project Leader- Technical Services

Creating, maintaining and updating S.O.P’s for efficient operation in manufacturing, created 27 new

S.O.P’s and updated 65 old S.O.P’s.

Planned, initiated and coordinated production in consultation with managers in compounding/ tabletting

capsulation area / packaging area. 50-55 batches / week

Responsible for creating master batch records (18-20 per month), for clinical manufacturing activities

and development studies for different 80 clients

Novopharm Ltd. Toronto (Teva Group of Companies) June 2002 – April 2004

Production Supervisor

Motivated and educated the support staff for reducing quality incident from 41 to 5 per month and for

production reliability increased efficiency from 55% to 75 % Trained staff for ultimate quality, G M P

and Health & Safety.

Suggested process improvements for cost control saved labor cost 48,000 $ per year

Managed pharmaceutical machineries at its maximum efficiency by reducing down time with help of

effective planning and scheduling activities from 38 hrs / week to 22 hrs /week, for dispensing &

blending system. Granulators, rotary tablets compression machines, tablet coating machines,

encapsulating machine & high speed bottle packaging lines.

Organized and executed all special projects of installation of new machines right from IQ /OQ /PQ and

achieved validation of products to comply statutory requirement

In coordination of technical services, investigated the root cause of flow problems and implemented

design change of manufacturing and packaging line which contributed to business growth and saved

money to the tune of $800,000,

Manufacturing Operator APOTEX (Toronto, CANADA) January 2001 – May 2002

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Setting up machineries required for dispensing & granulating the lots/ batches assigned as per

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manufacturing Order

Dispensed and processed batches of solid dosage pharmaceutical products 12 batches / week

documented production related data and entered it to inventory system ( SAP)

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Used various machines with advanced technology for milling / screening / mixing / blending /

granulating / compacting / compression jobs. trained team members for the effective and efficient use of

equipments

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Eupharma Laboratories Ltd. Ahmedabad .India June 1996 - August 2000

Production Manager

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Trained, guided & motivated supervisors for the better production performance with effective use of

each resource like, manpower / machineries & equipments / materials, having technical skills with good

understanding of pharmaceutical production

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Managed production of large volume parenterals viz. 5 % Dextrose 0.9% Saline, Metronidazol,

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Ringers’ lactate, PD Fluid, Tablets, Capsules, and liquid orals. Was responsible for installation,

qualification and validation for commercial operation of sterile plant (BFS) from Rummeleg Germany.

Managed Business for turnover of INR 185 Million

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Worked as a member of management team and coordinated activities of regulatory affairs purchase &

inventory/ distribution and logistic/ quality control and quality assurance.

Carried out plant audit and investigations on deviations on process and suggested permanent solutions

on cost control on energy / materials / manpower. saved in INR 8.0 Million on production cost in the

year 1998

Prepared application Files for new drug approvals and submissions. (ANDA) Submissions made for 12

products, marketing licenses were given to 10 products in asian and african countries

Production Executive October 1992 – June 1996

Unjha Formulations Ltd. Ahmedabad India

Managed production of liquid orals & injectable formulations with the help of 38 team members in

medium scale pharmaceutical factory.

Manufactured tablets/capsules/softgels for garlic oil, ergocalciferol, and Cod liver oil with packaging

operation on slat lines / powder fillers / blister packing / aluminum strips packing machines.

Managed all production records. prepared application files for 5 new approvals in co ordination with

regulatory affairs department

Production Chemist American Remedies Ltd. India June 1987 – September 1992

Worked in the manufacturing department and manufactured tablets and capsules as per manufacturing

orders cleaned and maintained manufacturing area and documented as per S.O.P.

Conducted In process checks to control quality of production. Worked on process development with co

ordination of Research & Development department, worked on IQ / OQ / PQ for the installation and

validation of different machineries. Participated in management meetings to understand the short term

and long-term objectives.

Education

M.B.A Specialization in Marketing 1999

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Masters Degree in Business Administration INDIRA GANDHI UNIVERSITY India

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M.Sc. Medical Microbiology 1987

Masters Degree in Sciences GUJARAT UNIVERSITY. India

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B.Sc. Chemistry Gujarat University 1983 Both Degrees are evaluated

B.Sc. Microbiology Gujarat University 1984 by University of Toronto. Canada

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Professional Training Courses.

Certificate Course in Total Quality Management KPMG 1990

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Certificate course in First Aid & CPR in CANADA. 2002

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Certificate Course in Time Management AMA 2003

Certificate course in Computer skills for MS Word, Excel, Power point.

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In CANADA 2004

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Professional Affiliation:

Member of ISPE.ORG, a community of pharmaceutical professionals supporting Process engineering,

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Management and technology,

Member of American Association of Pharmaceutical Scientist

Skills:

proactive, mature, hardworking and dependable professional with more than 24 Years of experience in

the field of Manufacturing, Research & Development, Regulatory Affairs, effective communication

through listening & efficient decision maker and good learner,

1. Leadership, Ownership, Health & Safety

2. Detail Oriented, Sharp Observation

3. Advanced Computer Skills (MS OFFICE, INTERNET) S.A.P, Oracle based ERP

4. Strong Mathematical Skills.

5. Mechanical aptitude, capable of understanding the concept / principle of any operating machine and

troubleshoot accordingly.

Reference: Will be available upon request.

Contact this candidate