Drug Development and Formulation Process Development Consultant

Expertise

• Formulation development and manufacturing technology of pharmaceuticals, nutraceuticals and cosmetics on any delivery platform.
• Analytical oriented work in solids, liquids, topical and sterile products, over the counter - OTC, non-prescription medicines, vitamins, and nutritional products.
• Development and manufacturing management with focus on dietary supplements, respiratory and personal care products.
• Technology transfer, scale up, facility pilot plant development encompassing; manufacturing, packaging, stability and warehousing.
• Site master plan equipment installation validation, cleaning validation, facility management requirements and compliance.
• Root cause analysis of any quality issue related to any manufacturing technology, reverse engineering and value engineering of any product.
• Manufacturing process experience of 28 years with concentration in process, qualification, validation, additionally, authored various documents, reviewed for accuracy and approved, for submission to regulatory bodies.
• Qualification in various measures, Design-DQ, Installation-IQ, Operational-OQ, Performance PQ, cleaning validation and Chemistry, Manufacturing and Controls, CMC section for submissions of IND/NDA/ANDA and CTD for pharmaceuticals.
• Project completion through technical principles in design of experiments and utilizing; Stat graphics, and Qualitek-4 (Taguchi Method).
• Extensive experience working with multiple regulatory bodies FDA, DEA (U.S.A.) EMEA, EFSA (Europe), TGA (Australia), NHPD, and HPFBI(Canada).

Expert Witness Experience

• Provide legal support in the following area:
• Glass manufacturing technology,
• Electrical motor and pump manufacturing technology, and chemicals manufacturing technology, acid dyes, reactive dyes, disperse dyes, VAT dyes, intermediate chemicals,
• Veterinary practices for all kind of animals,
• Medical technology, radiology, kidney transplant operations, lithotripsy, haemo-dialysis, histo-pathology lab and diagnostic procedures.
• Color patient care in ICU, including defibrillators, ECG,
• Lyophilization and aseptic manufacturing technology.

Experience

Undisclosed Company, Sr. Scientist, 2012 - Present

• Head of department: For new OTC product development in various dosage forms for tablets, capsules, soft gel oral liquids, powders and topical.
• Subject matter expert of manufacturing unit processes, development and manufacturing operations as well as compliance requirements in a cGMP environment.
• Review and selection of raw materials, review and selection of machines, IQ/OQ/PQ/ cleaning and process validation for technology transfer, optimization and pilot scale manufacturing.
• Formulation development and stability studies: 12 products. 28 SKU's OTC.
• Analytical method development and validation for all 12 products working closely with, analytical leaders and packaging technology colleagues.
• Implemented experimental design and analysis leading to robust conclusions and subsequent decisions.
• Developed 98 products in vitamins and consumer health product.

Captek Softgel International,Cerritos, CA, Consultant, 2012 - 2012

• Making assessment of all processes from weighing to compounding, milling, mixing, encapsulation, polishing, printing, and packaging of soft gel capsules and formulations of difficult to make products and making necessary changes.
• Assessment of research and development, and quality control activities, streamline in to requirement of process efficiency.
• Developed people and build departmental technology capabilities in cGMP facility.
• Evaluated new technology and product platforms as related to technology transfer, optimization and pilot scale manufacturing.
• Re-engineering processes and training supervisors and managers for change.
• Evaluating raw material specifications and making changes to reduce cost and quality related.

Isagenix International LLC., Chandler, AZ, Product Development Manager, 2010 - 2012

• Responsible to develop innovative health and beauty products, Supplements, oral liquids, powders, tablets capsules and soft gels.
• Managing team of 20 associates and 32 products, including formulation development, contract manufacturing at business partners and submission for licensing for global business of U.S. at $250 million.
• Recent saving production cost of $500,000 by implementing change in Fluid bed process.
• Resolved formulation /process related issues 5 in Tablets, 2 in softgels and 7 in different powder products.

Nutriforce Nutrition, Miami, FL, Sr. Manage, 2010

• Completed project to build new facility for oral liquids, creams, and Soft gels for nutraceutical, negotiating business requirements with vendors for material, machines and building contractors, engineers and designers, responsible for the project valued at $8 million, 80,000 sq. ft. including analytical laboratories with 2 HPLC and microbiology lab.

Patheon Pharmaceuticals Inc., Cincinnati, OH, Sr. Scientist, 2007 - 2009

• Developed pharmaceuticals formulations of "New Chemical Entities" for clinical trial batches and commercial production, managed 18 formulation development projects.
• Developed formulations for seven poorly soluble compounds and manufactured 126 batches for clinical trials for oral and topical dosage forms.
• Implemented process analytical technology for 2 topical products as leader.
• Member of six sigma team , applied principles of lean manufacturing.
• Technology development, technology transfer, problem solving of 18 product formulations.

Swiss Caps USA Inc, Mami, FL, Process Development Manager, 2005 - 2007

• Conducted preformulation studies (18 products), and optimizing formulation (7 products), resolving of process related problems, (21 products) and creating technology transfer, (4 products) for solid dosage form capsules, tablets and soft gels for pharmaceuticals and Nutraceuticals Products.
• Suggested new formulation developments to clients and got approval for submission to FDA, 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 Vega gel -Vegetarian Soft gel).

Pharmaceutics International Inc., Baltimore MD, Project Leader, Technical Services, 2004 - 2005

• Created, maintained and updated 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/ tableting 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) CANADA, Production Supervisor, 2002 - 2004

• 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, GMP and health and safety.
• 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 and blending tableting, coating, and packaging system.
• Organized and executed all special projects of installation of new machines from IQ /OQ /PQ and completed validation of 11 products to comply statutory requirement.
• In coordination of technical services, investigated the root cause of powder flow problems and implemented design change of manufacturing and packaging line which contributed to business growth and saved money to the tune of $800,00.
• Monitored production of tablets and capsules on Killian and Kikusui and Fette compression machines, Accelacota coating machines, OSAKA / MG 2 encapsulation machines and powder manufacturing / packaging lines.

Apotex, Toronto, Canada, Manufacturing Operator, 2001 - 2002

• Setting up machineries required for dispensing and granulating and tableting for the lots/ batches assigned as per manufacturing order used Glatt FBD for drying, granulation and coating, and Spheronizer for pallet manufacturing, worked on tablet compression using Korsch 400, capsulation on Zanasi.

EuPharma Laboratories Ltd., Ahmedabad, India, Production Manager. 1996 - 2000

• Tablets and capsules production of billion dosages units annually, including all activities of blending granulation, compression and coating and packaging.
• Controlled direct 8 reports and indirect 132 reports.
• Installed and validated new BFS technology machines for production of large volume parenterals 5 % Dextrose 0.9% Saline, Metronidazol IV Inj, Ringers' lactate IV Inj, PD Fluid IPD Inj, Cefotaxime IV Inj, Ketamine Inj, Ivermectin Inj, Ciprofloxacin Ophthalmic and liquid orals of Acetaminophen, Albendazole Suspension.

Honors & Publications

Credentials

• Recognized performance ratings of 4.0 to 4.5.
• Certificate Course in Total Quality Management - KPMG
• Certificate course in First Aid & CPR in CANADA
• Certificate In process Testing Tablets & Capsules Novopharm
• Certificate Course in Time Management - AMA
• Certificate course in Computer skills for MS Word, Excel, Power point
• Certificate in Granulation and Compression technology Techceuticals U.S.A.
• Certificate in Analytical HPLC, UV and Mass spectroscopy, Seneca college

Languages

• English
• Hindi
• Gujarati

Academic and Professional Affiliations

• International Society of Pharmaceutical Engineering - ISPE; a community of pharmaceutical professionals supporting process engineering, management and technology.
• American Association of Pharmaceutical Scientist

Publications and Patents

• Author of a book-Manufacturing Technology

Education

M.B.A. Marketing, Indira Gandhi University, India

M.Sc. Medical Microbiology, Gujarat University, India

B.Sc. Chemistry, Gujarat University, India

B.Sc. Microbiology, Gujarat University, India