Expert Details

Expert in Formulation

Expert ID: 735998 New Jersey, USA

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Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance.

Proven track record of 30 years in effective product development management, facility design and implementation of infrastructure. Experienced leader in cross functional team building, motivation and developing staff to deliver results. Expertise with variety of pharmaceutical processes and technologies. Developed ethical, generic and over-the-counter drug products. Steered due diligence process to extract best value for the acquisition. Comprehensive knowledge of global CMC, regulatory and cGMP compliance requirements. Experienced negotiator for sourcing key components and contract development / co-development projects. Managed large teams and annual budget of $12 million. Experienced in CMO and CRO management.

PROFESSIONAL STRENGTHS:
• Entrepreneurial Leadership
• Strategic Planning
• Methodology Development
• Infrastructure Development
• Project Management
• Quality Management
• Training & Development
• Strategic Partnership
• Global Operations Management
• Business Development

ACHIEVEMENTS:
• Designed and commissioned cGMP pilot and commercial facilities with implementation of standardized CMC documentation and QBD development structures.
• Trained and implemented IQ/OQ/PQ and preventive maintenance programs in Manufacturing.
• Validated utilities, HVAC, Purified water systems to comply with US and EU regulatory requirements.
• Transferred products from Old manual operations to Automated PLC based manufacturing equipments (Multiple products).
• Validated 50+ commercial products within regulated compliance guidance.
• Improved commercial yields by eliminating inspections and rejections.
• Championed fast-to-develop methodologies
• Set up state-of-the-art research and manufacturing units with a new concept to improve equipment performance and save long-term energy cost.
• Completed manufacturing plant design, equipment selection capacity planning for 80,000 sq. ft future commercial manufacturing facility.


Expert may consult nationally and internationally, and is also local to the following cities: Princeton NJ

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Education

Year Degree Subject Institution
Year: 2005 Degree: Ph.D Subject: Pharmaceutical Institution: North Gujarat University
Year: 1989 Degree: M.Pharm Subject: Pharmaceutics and industrial pharmacy Institution: LMCP Gujarat university
Year: 1987 Degree: B. Pharm Subject: Pharmacy Institution: LMCP

Work History

Years Employer Title Department Responsibilities
Years: 2019 to Present Employer: Undisclosed Title: Director Department: Research and Development Responsibilities: • Manage team of 7 scientist and technicians in development for OTC,
• Guide in development for Multivitamins and Nutraceuticals,
• Review and approve change control documents
• Guide and facilitate tech transfer from team of 20+ scientists from India R&D center.
• Oversee activities of 10+ ANDA development, pilot studies and planning for Pivotal.
• Review and bring changes to existing formulation and process for continuous improvement.


Years: 2013 to 2018 Employer: Vensun Pharmaceuticals Inc. Title: EXECUTIVE DIRECTOR Department: R&D AND TECHNICAL OPERATIONS Responsibilities: • Manage development at US and international contract partner locations.
• Review and evaluate development, QbD and clinical manufacturing activities.
• Review and refine PDR’s and regulatory submission documentation.
• Review and refine FDA deficiency responses.
• Manage scale-up, validation and address commercial manufacturing issues if any.
• Filed ANDA’s for 20+ highly complex products from stability, bio-equivalency variability and manufacturing process perspective.
Years: 2012 to 2013 Employer: Austar Pharma, LLC. Title: VICE PRESIDENT Department: TECHNICAL OPERATIONS Responsibilities: • Managed manufacturing facility and operations for facilities at 18 Mayfield Edison NJ.
• Managed manufacturing, information technology, engineering and warehouse staff and activities.
• Managed receipt, use, manufacture, storage and shipping of Drug product manufactured at 18 Mayfield Avenue Edison NJ.
• Provided technical guidance to R&D for development, clinical batch manufacturing and bio-equivalency study design as a CDMO organization.
• Reviewed and approved SOP’s, manufacturing batch records and final review.
• Reviewed and negotiated bio-equivalency contracts and protocols, documentation review and approval for international government agency application documentation required by CRO.
Years: 2011 to 2012 Employer: Pharmaceutics International, Inc. Title: SENIOR DIRECTOR Department: FORMULATION DEVELOPMENT Responsibilities: • Managed formulation development department for solid dosage and injectable areas as a CDMO
• Implemented scientific approaches to improve efficiency by scientific review debate and reduce experimental quantum.
• Recruited new candidates at several levels with appropriate education and attitude.
• Supported ramifications of technical issues as well as efficiency issues with existing commercial products.
• Resolved pending issues to accomplish product filing of three products.
• One product in Clinical study.
• Two products in Clinical manufacturing stage.
• Implemented new approach in cross-functional departments to a reasonable level, which translated in shift of momentum since Feb 2012.
• Transformed view of existing staff and significant productivity registered since Dec 2011.
• Implemented QbD principles and lean schemes on process optimization.
Years: 2008 to 2011 Employer: OSB Pharmaceuticals, LLC. Title: EXECUTIVE VICE PRESIDENT Department: Responsibilities: • Took charge of client’s administrative functions to establish a 30,000 sq. ft. R&D/pilot cGMP center.
• Nurtured formulation development and analytical development teams
• Provided input on Intellectual Property related to formulation, Regulatory issues and ANDA filing.

• Completed manufacturing plant design, equipment selection capacity planning for 80,000 sq. ft future commercial manufacturing facility.
• Screened projects (IP and formulation based) for fast-to-develop strategies and designed lean manufacturing schemes
• Designed and monitored construction of R&D/Pilot facility and equipment installation.
• Implemented QbD principles and lean schemes
• Set up a team by recruiting formulators, analytical/quality control chemists, quality assurance staff, regulatory affairs associates and manufacturing staff.
• Hosted training for technical and related matters
• Established systems and streamlined R&D operations to file three ANDA’s.
• Additional 6 molecules are at final stages i.e. ongoing bioequivalence studies, Clinical manufacturing etc. and will be filed in Next 3 to 4 months in 2011
• Designed an innovative process to develop an ER composition for Class II drug for which patent application is filed
Years: 2006 to 2007 Employer: Morepen, Inc. Title: VICE PRESIDENT TECHNICAL OPERATIONS Department: Responsibilities: • Responsible for all the technical aspects and operations in warehouse, manufacturing and quality control department.
• Responsible for business development, marketing and commercialization of ANDA’s in US.
• Presented business model and plan to several Venture Capital, Banks and Funds to secure $48 million funding for the company.
• Guided formulation, analytical and regulatory teams for both US as well as domestic markets.
• Developed four non-infringing formulation ready for pilot dosing.
• Changed 14 formulation in domestic and OTC export category to improve productivity and cost.
Years: 2002 to 2006 Employer: ZYDUS Pharmaceuticals, Inc. (USA) Title: DIRECTOR Department: FORMULATION RESEARCH Responsibilities: • Supervised formulation and analytical development centers and contract research companies for ANDA filing with U.S. FDA. Managed a recurring budget in range of $10 to $12 million a year for ANDA development. Managed multiple CRO’s.
• Established development teams with 14 formulation development scientists and 58 analytical research scientists.
• Designed, and built a new technology center to host global product development with 300 scientific staff.
• Built formulation, ADL & regulatory teams.
• Filed 40 ANDA’s in three years generating sales of over $200 million with portfolio of 11 Para IV filings, 6 Class II category and 8 with highly variable in-vitro with stability challenges.
• Delivered non-infringing bioequivalent formulations for which the generic entity was not sued.
Years: 2001 to 2002 Employer: Celltech Americas, Inc. Title: PRINCIPAL INVESTIGATOR Department: PROCESS TECHNOLOGY Responsibilities: • Managed a team of 14 process development staff responsible for scale-up and clinical supplies. Activities included solid and liquid dosage forms.
• Implemented innovative processes change for two NDA products. Implemented product transfer to modernize manufacturing facilities.
• Moved an NDA ER capsule formulation from a contractor to increase manufacturing scale and reduce cost.
• Stabilized two product processes, demonstrated equivalent clinical performance to satisfy FDA’s respiratory division, and brought a permanent closure on process control and product performance.
• Filed patent for a pennkinetic system.
Years: 1996 to 2001 Employer: Bristol-Myers Squibb Title: RESEARCH INVESTIGATOR TECH. SERVICES Department: Responsibilities: • Reformulated seven products to reduce overall rejection to save 22% to 30% on cost of goods.
• Developed innovative compositions and achieved 3+ Patents.
Years: 1993 to 1996 Employer: Invamed, Inc. Title: MANAGER Department: PRODUCT DEVELOPMENT Responsibilities: • Set up a state-of-the-art facility for ER and difficult products. Implemented validation schemes in an era when the concept was at infancy.
• Filed 24 ANDA’s and launched eight commercial products to achieve 35M in revenues.
Years: 1991 to 1993 Employer: Various Title: RESEARCH SCIENTIST Department: Responsibilities: Private Formulations, Edison, NJ
Sidmak Laboratories, East Hanover, NJ
Years: 1989 to 1991 Employer: Cadila Laboratories Ltd. Title: SECTION HEAD Department: NDDS & FOOD DIVISION Responsibilities: • Developed seven formulations for Tablets and capsules in DR/ER category.
• Developed Nutritional high protein and Vitamin biscuits.
• Completed Construction and commenced manufacturing out of a 40,000 sq. ft food products facility with gravity feed material flow in 8 months

Career Accomplishments

Licenses / Certifications
30 years as scientists and last 20 as executive leadership roles.
Publications and Patents Summary
Granted Patents: 3 (US)
Applications under review: 8
Other publications: 2

Fields of Expertise

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