Core Proficiency:
• Hands-on Pre-formulation/Formulation expertise for Small Molecules & Biologics (Rx & OTC drugs as skin protectants, corticosteroids, fever-reducers, laxatives, chemotherapeutics, hormones, enzymes, anti-inflammatories, antibiotics, mAbs etc.)
• Expertise in Novel Drug Delivery Systems: Nanotechnology, Lipid Systems, Encapsulations etc.
• NDA/ANDA submissions within tight timelines for various dosage forms (topical, oral etc.)
• Formulated for special disease conditions for pediatric/geriatric/adult populations
• Integrated CMC Development Strategies (including manufacturing of Clinical Trial Materials)
• Scale-up, Process Development, Commercial Manufacturing (In-house & CMO)
• Qualification of external CMOs for new product development & line extensions
• Leadership in Global Project Management expertise (in Fortune 50 Company)
• Lead IP related activities (10 patent pending products) for novel drug delivery systems
• Manage a highly efficient CMC/R&D team for rapid scale-up & commercialization
• Identify & align key operations/validation team leads for contingency/mitigation plans
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Summary: Accomplished technical manager with over 12 years of product development knowledge & project management skills in driving projects from concept to commercialization. Successful in development of more than 30 commercial products (Rx & OTC – small molecules & biologics) within tight timelines by proven leadership skills in managing matrix based CMC teams.
Manager R&D [Formulation & Process Development] @ Lead new products development portfolio of over $300MM involving 4 brands (Fleet, Phazyme, Pedia-Lax & BBP) for 15 new products
Support improvement of over 40 existing commercial products; Formulate strategic development of CMC plans, project analysis & deliverables, NPV calculation, life-cycle management, technical benchmarking, annual budgeting, pipeline & milestone decisions including asset management
Lead IP related activities (10 patent pending products) for novel delivery system of products for solid orals (chewables & compressed tablets), topical semisolids, oral liquids etc.
Manage a highly efficient CMC/R&D team for rapid scale-up & commercialization of new pharmaceutical products & product line extensions (by incorporation of DOE, QbD & PAT principles) for the treatment of various infant, pediatric & adult disease conditions such as gastro-intestinal disorders, hemorrhoids, bowel movement disorders, constipation, skin inflammatory conditions etc
Identify & align key operations/validation team leads for contingency and mitigation plans to expedite & ensure rapid scale-up & manufacturing processes through all life-cycle phases From January 2014 to Present (2 years) Lynchburg, Virginia AreaApplication Development Manager / Research Scientist, Advanced Delivery Systems, DCIS @ Managed Dow’s advanced delivery systems platform for stabilization & targeted delivery of actives for hard-to-formulate pharmaceutical products in solving formulation challenges;
Fast track product development by strategic partnering with CMOs & implementing rapid scale-up technologies by utilization of in-line monitoring systems using NIR & IR sensors for continuous manufacturing of products
Successfully led complex projects in a global scale by coordinating with various cross-functional independent global departments within Dow businesses by utilizing global project management tools to rapidly develop an innovation based portfolio with a net present value (NPV) of over $200MM comprising of pharmaceutical APIs, functionally active cellulosic excipients (for tablet coating, solubility enhancement of pharmaceutical actives etc.) & polymeric encapsulation of small molecules & biologics (for controlled release & shelf-life stabilization of drugs) From June 2011 to Present (4 years 7 months) Lead Product & Process Development Scientist @ Led a cross-functional project team of 15+ scientists/engineers to rapidly formulate drug products (Rx & OTC) containing small molecules & biologics for NDA/ANDA submissions within tight project timelines of 6 months to 1 year into various dosage forms for treatment of pediatric conditions (alcohol-free nasal decongestants, fever reducers), oncology treatment (oral & topical suspensions containing corticosteroids, hormones, anti-inflammatory, antibiotics, mAbs)
Implemented modern QS & manufacturing concepts for manufacturing such as Quality by Design (QbD), Design of Experiments (DOE), Process Analytical Technology (PAT) tools, Continuous Improvement, Lean Six Sigma Principles & troubleshot low-yield & out of specification (OOS) issues in large scale commercial batches up to 5000 kg including supporting technology transfer to partner CMOs, thereby gaining first-to-file marketing exclusivity From January 2009 to June 2011 (2 years 6 months) Buffalo/Niagara, New York AreaSenior Formulation Scientist @ • Formulated transdermal liposomal, micro & nanoparticulate based delivery system for small molecules, peptides and/or proteins for enhanced shelf-life & penetration across skin barrier
• Reformulated generic versions (Rx & OTC) of a branded products such as pediatric alcohol-free nasal decongestants, topical sprays, creams, lotions, ointments containing corticosteroids, hormones, anti-inflammatory, antibiotics, anti-cancers, analgesic, anti-acne actives
• Successfully managed commercialization projects by supporting technology transfer to partner CMOs and addressing modern QS concepts such as DIRs, CAPAs, Change Controls, Quality by Design, Continuous Improvement, Six Sigma Principles etc. for clinical trial supplies and commercialization From May 2008 to September 2010 (2 years 5 months) Scientist/Fellow @ From May 2005 to May 2008 (3 years 1 month) New Product Development/Intern @ From April 2005 to August 2005 (5 months) Drug Delivery/Industrial Pharmacy @ From August 2002 to May 2005 (2 years 10 months) Project Manager/Manufacturing @ From April 2001 to August 2002 (1 year 5 months) Manufacturing/Formulation Development/Intern @ From January 2000 to March 2001 (1 year 3 months)
HBX - CORe [Credential of Readiness], Financial Accounting, Managerial Economics, Business Analytics @ Harvard Business School From 2015 to 2015 Executive mini-MBA, Business Administration, Management and Operations @ State University of New York at Buffalo - School of Management From 2015 to 2015 Industrial & Physical Pharmacy @ Purdue UniversityPharmaceutical Sciences - Drug Delivery @ Saint John's University Debanjan Das is skilled in: Formulation Development, Drug Delivery, Project Management, Development Applications, Targeted Drug Delivery, Semisolids, Pharmaceutical Industry, Pharmaceutics, Topical Medication, Scale Up, Pilot Plant, Drug Development, Personal Care, Cross-functional Team Leadership, Formulation