Drug Product and Process Development, Process Manufacturing, and GMP Documentation Expert

Expertise

• Pharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.
• Product development using QbD approach, process scale-up and optimization, process validation.
• Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormonal products.
• Troubleshooting, manufacturing, technology transfers, and site transfers.
• Pharmaceutical machinery: High and low shear granulators, fluid bed processors, sizing mills, tablet presses, encapsulators, powder fillers, ampoule and vial fillers, bottle fillers, autoclaves, dry heat sterilizers, blister pack machines.
• Question based review documents and quality overall summary documents in support of ANDA submission
• Evaluate and identify various technologies such as matrix based systems for MR products, polymers based functional coating of products, coating of API on core tablets, solvent based granulations for products containing "high potency" compounds and developing products which are "difficult to replicate" and with "controlled substances" to benefit company
• Pharmaceutical quality/CMC preparations for phase 2 & 3 studies under IND and ANDA fillings in pharmaceutical industry for FDA.

Experience

Independent Consultant, 2013 - Present

Projects

• Principal Consultant and Formulation Manager to McNeil, J&J.
• Successfully carried out OTC softgel product development with the help of CMO.
• Successfully developed orally disintegrating granule product (QbD approach) to launch.
• Involved in creating, reviewing documents complying with McNeil's standards.

Dr. Reddy's Laboratories, Shreveport, LA, Vlaliation Engineer, 2013

• Successful troubleshooting of Ibuprofen tablets compression and coating issues.

Janssen, Contractor and Consultant, 2012 - 2013

• Responsible for process characterization, technology and site transfers of OTC products.
• Worked on batch sizes up to 650 kg using Tote bin blenders, Fette and Manesty Elite presses and Bohle BFC 600 Coating pan with eight nozzles.

Spectrum Pharmaceuticals, Irvine, CA, Senior Manager, Formulation Development, 2010 - 2012

• Led formulation and process development to support clinical studies in multiple indications in oncology and urology
• Worked closely with API manufacturers globally to achieve the intended quality of the drug substance influencing the development of drug product
• Successfully developed a solid oral product for "first in man" study. The API has "nano-particle" size between 30 and 100 nm.
• Successfully carried out site transfer of a peptide injectable product for Phase II clinical supply.
• Successfully developed a "lipid based" formulation in hard gelatin capsules of a cytotoxic drug to be administered orally for the first time in man.
• Responsible for identifying and selecting CMOs and project management at CMOs.
• Developed a "delayed released" product (functional coating) of a high potency drug used as "radiation sensitizer" in cancer patients and subsequently managed the clinical supply of the same at a overseas CMO.
• Worked closely with Regulatory group for IND updates and annual updates.

Norwich Pharmaceutical Inc., Norwich, NY, Senior Process Engineer, 2019 - 2010

• Led the development of Trans-dermal drug delivery System containing "high potency" compound using Harro-Hoefliger Patch Machine.
• Technical resource to the business development group, acting "liaison" between the client and the group as well as identify "new technologies" for the company.

Watson Pharmaceuticals Inc., Corona, CA, 2002 - 2009

Senior Pharmacist, 2003 - 2009

• Managed pre-formulation and formulation development for solid oral dosage forms involving studies such as particle size analysis by Malvern, electron microscopy for coating thickness determination, reverse-engineering of marketed products using size exclusion chromatography.
• Implemented QbD approach towards product and process design and development.
• Led scale up, technology transfers and site transfers of immediate and modified release tablet dosage forms, oral contraceptives and products containing "high potency" compounds and large molecules.
• Led process design and optimization, process qualification under overall process validation program. Worked closely with pharmaceutical technology and manufacturing groups to run validation program.
• Responsible for writing product development and process optimization reports.
• Co-developed and filed two immediate release and two sustained-release products under ANDA. One immediate release and one sustained-release product received FDA approval,
• Successfully scaled-up from GPCG 5 to GPCG 60 two products containing " compounds resulting into ANDA filing, one of which, Ethinyl Estradiol / Levonorgestrel Tablets(generic version of "LYBREL™)under first to file" category.
• Worked closely with lead formulator to develop an immediate release product containing large molecule of immune-suppressant resulting into FDA approval.
• Co-developed two products with "controlled substances". One product had a successful pilot bio-study.
• Responsible for generating protocols, batch records, as well as question based review documents and quality overall summary document for ANDA submission.
• Involved in investigations and CAPA. Also conducted literature and patent search.

Manufacturing Manager, 2002 - 2003

• Managed hormonal product manufacturing facility.
• Successfully scaled up two oral contraceptive products in Collette 600.
• Introduced first time in the company multi-tip tooling.
• Increased production output by 40% for three products by successfully integrating the additional bowls for Collette 300 and 600 in the system.
• Involved in investigations/ CAPA, change controls, general GMPs, documentation.
• Involved in process validation, closely working with Pharmaceutical Technical Department.

Patheon, Inc., Mississauga, Ontario, Canada, Senior Process Engineer, 2000 - 2002

• Successfully scaled up two products (one from PMA 65L to PMA 300L and the other one from PMA 300L to PMA800L scale in support of NDA applications. Products were subsequently launched in the U.S.
• Conducted feasibility studies, optimization studies and scale-up work in aeromatic-fielder granulation and fluid bed drying systems involving equipment.
• Led site transfer (from Europe to Canada) of a topical product.
• Successfully developed a solvent-based granulation process for a hormonal product.

Apotex Inc., Toronto, Canada, Technical Specialist, 1998 - 2000

• Developed immediate release tablet formulation using Gerteis compactor to support ANDA submission by Apotex.
• Resolved production support problems such as granular flow, tablet disintegration and dissolution, assay, color distribution, tablet edge-wear during coating, picking during coating for solid dosage forms resulting into savings of millions dollars in terms of customer service and quality products.

Tabuk Pharmaceutical Manufacturing Company, Tabuk, SA, Production Manager, 1995 - 1997

• Substantially contributed towards setting up of a multi-million dollars major manufacturing facility to produce solids, liquids, semi-solids, liquid and solid injectables.
• At a separate facility that manufactured cephalosporin containing dosage forms such as capsules, dry powders, oral suspensions and injectables.
• Involved in process characterization and validation.
• Plant was commissioned in a record time

E.Merck, Mumbai, India, Production Manager, 1986 - 1994

• Introduced film coating using Eudragit polymers.
• Head of operations for liquid orals, solids, injectables (small volume parenterals, X-Ray contrast media and Lyophilized products) and packaging departments.
• Key member of the technical team to set up tablet and liquid injectables (Bosch aseptic filling line) manufacturing facility in Goa, India.

Accomplishments

• Served as key role in evaluating and identifying various technologies such as matrix based systems for MR Products, polymers based functional coating of products, coating of API on core tablets, solvent based granulations for products containing "high potency" compounds and developing products which are "difficult to replicate" and with "controlled substances" to benefit company. Responsible for writing protocols and reports.
• Led the development of solid oral and injectable formulations consisting of highly potent small molecules, cytotoxic drugs and peptides for Phase I and II clinical trials.
• Adapted QbD approach to product and process design and development.
• Responsible for generating Question based review documents and Quality overall summary documents in support of ANDA submission.
• Extensive interactions with various departments in the organization such as QA, Regulatory, Project Management, Medical / Biopharmaceutics, Marketing, and Finance.
• Developed solvent based process for manufacturing products containing hormones and steroids" using stat of the art pharmaceutical equipment and machines.
• Self-motivated, able to work effectively with other professionals from Quality Assurance, Pre-clinical and clinical, Bio-Pharmaceutics, Regulatory Affairs and marketing.
• Responsible for setup of a major manufacturing facility in Asia.
• Experience in Pharmaceutical Quality/CMC preparations for phase 2 & 3 studies under IND and ANDA fillings in pharmaceutical industry for FDA.
• Involved in investigations and CAPA, change controls, general GMPs, documentation.

Honors & Publications

Credentials

Technical Courses - Management

• Supervisory Training, Leadership Strategies & Project Management, Trainer Development, Total Quality Management, Kaizen and Lean and Flexible Management.
• Statistical Design of Experiments (DOE) for pharmaceutical process research and development and manufacturing: A Practical Approach (Sponsored by University of Wisconsin)
• AAPS Workshop on Real World Applications of PAT and QbD in Drug Process Development and Approval, Co-sponsored with FDA and PhRMA
• Process Analytical Technology (PAT) Workshop conducted by Institute of Validation Technology
• AAPS Workshop on Practical Approach to Current Pre-Approval Inspection Initiative: GMP and GLP,
• "Preparing for a successful FDA Pre-Approval Inspection"

Languages

• English (Very fluent, conversation, writing and reading)

Academic and Professional Affiliations

• Post-doctoral research fellow at School of Pharmacy, University of Iowa,: Preformulation and formulation problems associated with a prodrug of phenyleprine to be marketed for use in ocular surgery.
• AAPS abstract reviewer
• AAPS "Visiting scientist" delivered a lecture at University of Southern California, School of Pharmacy
• Professor of Pharmaceutics in the School of Pharmacy, Western University, Pomona, CA

Publications and Patents

• Protective effect of "AP-101" against Carbon Tetrachloride induced liver damage in rats.
• Current Medical Practice - Author
• U.S Patent Pending- Lanthanum Carbonate Hydroxide, Lanthanum Oxycarbonate & Methods of their manufacturing and use.

Education

• Ph.D. Pharmaceutical Technology, University of Bombay, Mumbai, India
• MPharm. Pharmacology, University of Bombay, Mumbai, India
• BPharm Pharmaceutics, Pharm-Chemistry, Pharmacology, Pharmacognosy, University of Bombay, Mumbai, India