Providing Research & Development (R&D) and Manufacturing Science & Technology (MS&T) consulting services to pharmaceutical companies in the Innovation / Brand, Generic Rx, or Consumer Healthcare (OTC) industries. Extensive international travel and interaction with site operations, R&D and quality teams to conduct pharmaceutical technology gap assessments and remediation to develop compliant systems aligned with US FDA QbD principles.

Led early to late-stage liquid and solid oral dosage products formulation development, analytical methods development / validation / transfer, scale-up, clinical trial manufacturing, and technology transfer for new Generic Rx ANDA and Over the Counter (OTC) ANDA pharmaceuticals, NDA 505(b) (2), OTC Monograph, and Dietary Supplements products to US production sites. Championed research and development teams (over 120 professionals) at 3 different R&D Centers (Michigan, New Jersey, India). Led R&D Project Management Group accountable for pipeline portfolio oversight of ~60 new product projects (project approval/start through FDA regulatory filing), partnering with the corporate stage gate PM organization. Created and owned Operating Expense (OPEX) budget ($55M, equivalent to ~3% of net sales for OTC business unit) and Capital Expenditures (CAPEX) ($1.5M) budget.Vice President, Over-the-Counter (OTC) Pharmaceuticals R&D | 2018 to 2022Senior Director, US Consumer Healthcare (CHC) R&D | 2016 to 2018Senior Director, Formulation R&D, US Consumer Healthcare | 2012 to 2015Acting Head, Perrigo-Mexico R&D (Formulation & Analytical Development) | 2014 to 2015Site Head, Perrigo-NJ (Consumer Healthcare R&D Center) | 2012 to 2014Senior Director – Process Development & Technology (US CHC) | 2010 to 2012

Directed process development and commercialization activities for robust and scalable new immediate release and modified release solid oral dosage forms in close collaboration with the Senior Director of Product Development to facilitate “First-to-File” and “First-to-Market” corporate goals. Submitted 13 new ANDA’s to the FDA (10 ANDA’s during 2009). Designed and commercialized Impax’s generic version of enlarged prostate treatment drug and Flomax, (Tamsulosin Hydrochloride 0.4 mg Capsules), including process development / scale-up, technology transfer, and process validation, resulting in successful launch.

Led technology transfer of new products from R&D into Manufacturing through formulation development, process scale-up, process validation, and cleaning validation. Provided technical support for Watson’s (Andrx’s) Marketed Products through troubleshooting of problematic processes at various manufacturing facilities and process re-validation activities. Championed qualification efforts for alternate Active Pharmaceutical Ingredient (API) and excipients programs. Initiated and managed department Operating Expense (OPEX) budget ($3.7M) and Capital Expenditures (CAPEX) ($3.1M) budget. NDA Products included: Watson’s (Andrx’s) NDA (505(b)(2)) submissions for Lovastatin XL Tablets, 10 mg, 20 mg, 40 mg & 60 mg (Altoprev® Tablets), and Metformin XT Tablets, 500 mg & 1000 mg (Fortamet® Tablets).Director, Pharmaceutical Technical Services (R&D) | 2003 to 2008Associate Director, Technical Services & Technology Transfer (R&D) | 2001 to 2003

Manager, Principal Engineer, Senior Engineer, Senior Scientist / EngineerDesigned and delivered formulation and process development/improvement for a variety of pharmaceutical dosage forms (tablets, capsules, liquids, ointments, creams, intranasal suspensions and metered dose inhalation aerosols) for both Innovation / Brand (NDA 505(b)(1)) new products and their line extensions ( (NDA 505(b)(2)) through laboratory and pilot plant studies, and production scale-up. Provided technical support for marketed products through troubleshooting and optimization of problematic processes at manufacturing facilities in New Jersey, Florida, and Puerto Rico. Major accomplishments: Theophylline Extended-Release Pellets (for Theo-Dur® Tablets, 100 mg) - created and implemented a fluidized bed coating process on a Glatt GPCG 300 to replace the current conventional pan coating process, yielding cost savings of ~$210K per year and capital cost avoidance of ~$870K, improved safety and environmental compliance through the elimination of chloroform use. Potassium Chloride Crystal Extended-Release Coating Process (for K-Dur® Tablets) - increasing batch size (+60%) and reducing methylene chloride and methanol solvents in the formulation, resulting cost savings of ~$ 7M. Uni-Dur® Tablets, 400 mg and 600 mg 24hr Extended Release Tablets - Secured ANDA approval from FDA and launched the product.