Sanjay Sharma (MBA, MS)

*** ********* ****** ***** #*, Cockeysville, MD 21030

801-***-**** (H), 801-***-**** (C), acy5oq@r.postjobfree.com

PROFILE

Over 20 years of experience in managing development of NDA and ANDA products from formulation research through late stage development and commercial manufacturing.

Experienced in developing products based on Risk analysis using QbD approach.

Authored CMC portions of IND, NDA, and ANDA filings including Annual product reviews.

Expertise in due-diligence of products and organizations for in-licensing.

Played major role in development of following branded products: Oxytrol, Gelnique, Intrinsa (with P&G), Synera, ThermoProfen with CHADD technology and other products.

PROFESSIONAL EXPERIENCE

Pharmaceutical Consultant (2015- Till Date)

Consulted for Lehigh Valley Technologies, DP Clinical, Pala-tech and Upsher-Smith.

Providing expertise on process scale-up and CMC documentation based on QbD approach.

Technology and Product due-diligence to determine in-licensing opportunities.

Develop engineering studies and process validation studies to improve process variability.

Review FDA’s 483 observations and develop an appropriate CMC response.

Hercon Pharma, Emigsville, PA . (2012 – 2014)

A specialty pharmaceutical company developing generic and branded products.

Director Research and Development (2012 – 2014)

Led technology transfer of analytical methods and process for manufacturing of a generic product from an overseas organization.

Developed process for CTM manufacturing and authored CMC sections for ANDA filing.

Evaluated resource gaps in the R&D group, developed job requirements and hired resources to staff the organization.

Determined analytical and process equipment needs. Purchased HPLC and Dissolution equipment and managed IQ/OQ/PQ of equipment prior to use.

Redesigned manufacturing and scale-up facility, added security to building and process areas for handling of schedule II drug and drug products.

Directed meetings with project teams to accomplish analytical and process transfer including manufacturing of product for clinical studies and registration batches.

Created project plans, monitored progress, cost and timelines. .

ZARS Pharma, Salt Lake City, Utah. (2005 – 2011)

A specialty pharmaceutical company developing topical administered drugs in pain and dermatology area. ZARS Pharma has two products approved by FDA and several products in clinical trials.

Associate Director (Technical Operations) (2007 – 2011)

Senior Manager (2005 – 2007)

CMC AND PROCESS DEVELOPMENT

Responsible for technology transfer of manufacturing commercial product to a new contract manufacturing organization. In addition, streamlined the analytical methods for raw material testing and product release for both European and the US regulatory filing.

Used design of experiments to optimize process for CMC section of NDA filing.

Suggested and implemented a short term strategy and a long term strategy to eliminate defect rate for commercial product.

Proposed and led a strategy to reduce COGS of commercial product by 42%. Estimated cost was > $8 million with ROI < 2 years.

Designed and managed experiments to investigate OOS and OOT. Performed root cause analysis and collaborated with the quality group to develop corrective and preventive action plan.

RESEARCH AND DEVELOPMENT

Wrote and reviewed CMC sections for pre-investigational new drug (pre-IND), IND, and end of phase 2 briefing and registration documents, various amendments to INDs, and annual updates.

Developed novel transdermal and topical formulations in pain, dermatology, and for other indications.

Led inter-disciplinary team of QA, Manufacturing, and Research in solving stability issues with late stage product.

Contributed to 2 pre-IND meetings, one EOP 2 meeting and one pre-phase 2 meeting with the FDA.

Selected and worked with consultants/thought leaders on trouble-shooting project development activities.

PROJECT MANAGEMENT

Led technical efforts on one commercial product, one late stage clinical project and 3 early stage clinical projects.

Managed an operational budget of over $2 Million and a capital budget of $1.5 Million.

Worked closely with Regulatory, Internal and External QC, Sales and Marketing, and Senior Management to develop project plans and ensure successful completion of projects.

Oversaw forecasting, budgeting, hiring, and training for the technical operations group and supervised activities of Engineers and Scientists.

Participated and contributed in annual strategy meetings with senior management to develop organizational goals, strategy and vision.

Developed deliverables for projects, determined critical paths, prepared development reports, and recommended strategies for steering projects.

Managed CRO’s and CMO’s for analytical method development and production of clinical supplies.

Atrix labs/QLT, Fort Collins, Colorado. (2004 – 2005)

Atrix labs, which merged with QLT in late 2004, focused on developing a diverse portfolio of products including proprietary oncology, pain management and dermatology products. It had strategic alliances with several pharmaceutical companies including Pfizer Inc, Sanofi-Synthelabo Inc, MediGene AG, Fujisawa Healthcare Inc, and Elan International Services.

Senior Scientist (2004 –2005)

Formulation development and scale up of creams, ointments, lotions, and shampoos for ANDA filing.

Develop corticosteroid based products for 505 b (2) applications.

Member of strategy team to Integrate research activities between Fort Collins and Vancouver sites.

Developed relations with other organizations to identify API’s for mutual collaboration.

Watson Pharmaceuticals, Salt Lake City, Utah, (1999 – 2004)

Watson pharmaceuticals is a global specialty pharmaceutical company with approximately $3 billion in revenues, a broad product line and operations in well-established and emerging markets. It develops products in generics, brands and biopharmaceuticals that will deliver long-term growth.

Manager (Research and Development), (2002 – 2004)

Senior Scientist, (2001 –2002)

Project Leader/Scientist III, (1999–2001)

PROJECT MANAGEMENT

Worked closely with senior management to define research goals and provide counsel on long-term product development.

Managed an operating budget of $900,000 and a capital budget of $1.2 million.

Collaborated on developing a performance matrix to track progress and enhance efficiency.

Oversaw the administrative and managerial direction for 11 scientists with three (3) senior scientists as direct reports.

Define project tasks and timelines, critical path, assign resources, and track project progress using MS-Project.

RESEARCH AND DEVELOPMENT

Authored technical reports, product development reports and technology transfer reports for scale-up to operations.

Developed and transferred two (2) novel gel formulations and one (1) matrix formulation for NDA in 15 months.

Supervised and mentored different functional groups as formulation design, polymer science, and analytical method development.

Served as the project lead for a P & G sponsored project with cost estimate of $1 million/year.

Developed collaborations with partners to explore novel product ideas for drug delivery.

Developed protocol and conducted irritation and sensitization studies with animals

TheraTech Inc, Salt Lake City, Utah, (1996 – 1999)

Theratech Inc was a drug delivery company that pioneered development of transdermal systems and topical formulations in areas of hormonal delivery.

Scientist II (1996 – 1999)

Developed Dry Powder Inhalation formulations of drug and carrier particles by optimizing time and speed of blending.

Designed a spray drying system to increase collection efficiency by 20%.

Routinely used HPLC, GC, GC/MS, LC-MS, PDA, and FTIR for analysis of drug in organic and aqueous samples.

Assayed formulations for content uniformity according to USP specifications.

Developed DPI formulation with 15% better-emitted dose than commercial formulation.

Designed an apparatus for measuring emitted dose of commercial dry powder inhalers.

Used statistical software MiniTab for determining bio-equivalence of formulations.

Performed solubility and stability studies with various drug substances, selected combination of penetration enhancers for synergism in skin flux.

EDUCATION

Masters of Business Administration Brigham Young University, Utah GPA 3.99, Dean’s List

Masters of Science, Chemical Engineering University of Utah, Utah GPA 3.8

Bachelors of Technology, Chemical Engineering Osmania University, India Ranked in top 5%.

ADDITIONAL TRAINING:

Effective Technical Writing: American Management Association, New York, New York.

Management Certificate Program: University of Utah, Salt Lake City, Utah.

Management Development Program: Watson Labs, Salt Lake City, Utah.

Applied Statistics: Institute for Professional Education, Arlington, Virginia.

MS Access 2000: New Horizons, Salt Lake City, Utah.

Patent fundamentals for scientists, Arlington, Virginia.

A Systems Approach to Drug Delivery: University of Utah, Salt Lake City, Utah.

FTIR- Microscopy and Interpretation: ThermoNicolet, Madison, Wisconsin.

Advances in LC/MS & Millennium 3.2: Waters Corporation, Milford, Massachusetts.

Developing HPLC Separations: Waters Corporation, Milford, Massachusetts.

ASSOCIATIONS

Member of American Association of Pharmaceutical Scientists - Since 1997.

Member BGS Honor society.

Volunteered for Winter Olympics held in Salt Lake City – 2002.

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