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Dr. M. K. Singh (16-02-2017)

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Dr. M. K. Singh (16-02-2017)

  1. 1. Page 1 of 5 Curriculum Vitae Dr. Manoj Kumar Singh Date of Birth: January 21, 1968 M.Sc., Ph.D. (Synthetic Organic Chemistry) Contact Details: Flat No: D-504, Shangri La Apartment, Opp. Gorwa Lake, Subhanpura, Vadodara – 390 003. Gujarat, INDIA Cell : +91-99090 10491 Cell : +91-98250 84633 E. Mail: Objective: To get a full time role in the field of Active Pharmaceuticals Ingredients (APIs), Custom Contract Research Manufacturing (CRAMS) and / or Specialty Chemicals Developments, where I can utilize my knowledge and skills. Professional Strengths: 1) Academics & Researches: • Ph.D. in Organic Chemistry with total 27 years research including 21 years industrial experience having strong ability and experience in technical leadership with process chemistry development and manufacturing of Active Pharmaceutical Ingredients (APIs) and in CRAMS services. • Received Certificate of Appreciation from American Chemical Society publications for contribution and services in the peer review of manuscripts for ACS Journals. • Guidance of number of M. Pharm. / M.Sc. students for completing their dissertations reports during my research work as a part of Industry-Academic collaboration. • Interaction with other research and testing laboratories for technical, administrational matters as per the organizational needs. 2) Intellectual Property: • Have filled more than 30 Patents applications globally, out of which many patents are granted in US, Europe and many others countries; and published number of research articles in reputed research journals (Annexure-1). • Strongly efficient in reading, understanding and interpretation of patents languages and claims. • Strong in drafting complete specification of patents with claims. 3) Technical / Industrial: • As an industrial research scientist performed multiple task as per the requirement of the organizations. APIs: Developed more than 80 Active Pharmaceutical Ingredients (APIs) of various activities and their intermediates with more than 50 DMF filings for global regulated generic market including US / Europe / Japan etc. HIPO: Developed of many High Potent (HIPO) APIs, including Cytotoxic (ONCO) / Non-Cytotoxic Anticancer APIs, Steroids and other High-Potent products. Conceptualization of HIPO concept and implementation for different class of High Potent molecules from lab to plant scale using containment facilities. DMF Filing: A large number of APIs are developed for regulatory market complying cGMP norms and actively involved DMF filling for same including the molecules selected for FTF filing. Supported multiple audits from various regulatory bodies. CRAMS: Handled multiple CRAMS project with complete project management for various multinational companies including NOVARTIS-Switzerland, MERCK-USA, TESARO-USA, DUPONT-USA, ASTRA ZENECA-Sweden and many others. • Experienced of leading and developing the team of skilled professionals involved in various activities for development of Active Pharmaceutical Ingredients (APIs) for global regulated generic market. • Have very good strength in developing operationally simple, cost effective, patent non-infringing and independent processes for DMF filing, including products with FTF opportunities.
  2. 2. Page 2 of 5 • Have strong internal competence in the development in the area of Active Pharmaceutical Ingredients by design, synthesis, characterization and translation of lab process to the plant scale following cGMP norms. • Experienced in creating Design Space for QbD by DoE and PAT tools and techniques using Taguchi approach. • Exploration of non-infringing / novel crystalline farms to come out of polymorphs patent issues for APIs. • Designing non-infringing or novel synthetic routes to target molecules, and modify reactants and/or equipment as required. Solve the more complex chemical problems with help of Modern and classical organic chemistry, in both practice and theory. • Reformulation and cost reduction of existing product for quality improvement and cost competency as per guidance and identifying bottlenecks and de-bottleneck by providing regular technical inputs, resources and equipment. • Developed Innovative Process including novel intermediates for many compounds for DMF filing with compliance of cGMP, GLP and regulatory requirements. • Have strong knowledge of all modern techniques of synthetic organic chemistry, instrumentation (IR, UV, NMR, Mass, GC, GC-MS-MS, LC-MS-MS, HPLC, HPTLC, XRD, TGA, DSC etc.), extensive experience in developing complex organic molecules process and technology, transferring R&D process to pilot plant and commercializing the products at plant level. • Actively involved in the creating the new technology platform by the scope, application and scale-up of Bio-catalysis in process research development and cost reduction of APIs. • Project planning, execution and documentation of scientific activities as per quality standards, technical specifications and regulatory requirements. • Technical and operational training to production of any upcoming new technology, process or equipment. • High priority for the person, plant and process safety. Designing the process in such a way that it should be safer at commercial scale. 4) Regulatory cGMP: • Well aware of the procedure and requirements of regulatory filings, regulatory affairs, GMP, cGMP and writing skills of various patents and have very good techno-commercial skills. • A large number of products are developed for global regulated market and DMF filed / under filing. Actively involved in DMFs filing from HAPI plant and active involvement in successful DMF inspections. • Conceptualization and active participation in development of containment facility for plant scale, monitoring of IQ / OQ / PQ of new plants for HAPI molecules / Oncology products and Steroids. • Implementation of Quality Assurance (QA) functions and Quality Management System (QMS) requirements (Both Management and Technical). • Ensure accurate documentation of scale up in standardized templates to aid production and is in line with regulatory / FDA requirement. • Well verse with the critical quality attribute as an essential aspect of a manufacturing control strategy. • Experienced in the preparation of technical reports, manuscripts, and other documents with high level of accuracy. • A number of products developed for domestic market were first launching in India, for that all required documents for DCGI / CDTL and for other licensing authorities were prepared. • Review of dossiers and assessment of manufacturing processes, parameters, equipments for transfer products to comply with scale up and post approval changes & other regulatory guidelines. Educational Qualifications: Ph. D. Banaras Hindu University (BHU), Varanasi (1996) Synthetic Organic Chemistry. M. Sc. Meerut University, Meerut (1989) Chemistry (Organic). B. Sc. Meerut University, Meerut (1987) Zoology, Botany, Chemistry.
  3. 3. Page 3 of 5 Career History and Achievements: Period : From January 23rd 2014 to December 30th 2016. Organization : ALEMBIC PHARMECEUTICALS LIMITED, Vadodara. Designation : General Manager – API (Generic Research-Process Excellence). Responsibilities & Achievements:-  Developed more than 20 APIs and related advance intermediates for generics market preferably for FTF launching. The products developed for Para-IV FTF filings are Vilazodone, Ticagrelor, Bosutinib, Ibrutinib, Canagliflozin, Dapagliflozin and Empagliflozin along with other products for P-III filings such as Erlotinib, Gefitinib, Sorafenib, Minodronic Acid, Azilsartan, Febuxostat (Form-III) and many more.  Worked for multiple molecules including Anti-Cancer and other areas for the internal and global external customers mainly for FTF filing products.  Leading various teams of scientists involved in strategic planning and execution of lab development, optimization and scale-up test batches. Lead & control manufacturing technology transfer process to produce consistent quality over time from technology transfer.  Lead group of technology transfer engineers to plan for development of robust formulation and ensure smooth scale up at exhibit and manufacturing plant.  Responsible for review of all the SOPs, technical packages / dossiers and assessment of manufacturing processes, parameters, equipments for transfer products to comply with scale up and post approval changes & other regulatory guidelines.  Analyze the product strategy, efficiency, and working relations and cross functional issues, technology transfer for new project to production plant.  Guided project team for creating a facility for production of Class-3 (OEL) Active APIs, using experience and knowledge.  Guided project team to create n-BuLi facility at commercial scale and training of R&D, technology transfer and production team for same. Period : From January 2013 to August 2013. Organization : DISHMAN PHARMECEUTICALS LIMITED, Ahmedabad Designation : Head (Oncology-API and HIPO Research). Responsibilities & Achievements:-  To develop HIPO – APIs for generics market and HIPO intermediates for CRAMS services, starting from micro level to commercial scale and to ensure smooth scale-up up to pilot plant and support to API processes for commercialization.  Leading a team of CRD and ADL Scientists supported by DQA and production team.  Developed Pemetrexed, Gemcitabine, Aberiterone for generics market preferably for DMF filing.  Worked for 3 High-potent molecules for CRAMS services for Novartis-Switzerland, MERCK-USA and TASARO-USA.  Overall responsibility to run all operation smoothly in the HIPO - R & D and plant areas ensuring the complete documentation and implementation of protocol in HIPO R & D and plant.  Complete project management of CRAMS projects for HIPO projects from R & D to commercial scale. Period : From August 2005 to December 2012. Organization : CADILA HEALTHCARE LIMITED, Ahmedabad. Designation : General Manager & Head (Strategic Technology Development). Period : From April 2009 to December 2012. Designation : Deputy General Manager (Strategic Technology Development). From August 2005 to March 2009. Responsibilities & Achievements:-  Developed approx. 36 API Molecules and their advance intermediates with leading three research groups of R&D Group Leaders and Scientists engage in various activities of the group: Group-1: Lead the process development group and scale-up of non-cytotoxic anticancer molecules, Steroids (for both domestic and regulatory market) and NPDs (New Product Development). Some of the products with significant contributions are Letrozole, Anastrozole, Bicalutamide, Exemestane, Budesonide, Ciclesonide, Fluticasone Propionate, Fluticasone Furoate, Ulipristal Acetate,
  4. 4. Page 4 of 5 Triamcinolone Hexacetonide, Nomegestrol Acetate, Conivaptan, Tolvaptan, Mozavaptan, Alvimopan, Illaprazole, Alitretinoin and many more. Group- 2: The group involve in the down-streaming of the bio-catalysis processes and exploration of bio-catalysis in the existing APIs. Mainly works done in this category were for Sitagliptin, Tamsulosin, Tagatose, Solifenacin and Statin side chain. Group-3: The group is dealing with the isolation / synthesis / characterization of the impurity generated during the different stages of the formulation for ANDA filing.  To develop APIs starting from micro level to commercial scale and to ensure smooth scale-up up to NPD pilot plant and support to API processes for commercialization.  Trouble-shoot cross-functional issues with other functional heads and stakeholders (QA/QC/IP/Markets, Manufacturing etc.).  Review & ensure that all project tracking documents are duly completed and up to date as per cGMP and other regulatory requirements.  To facilitate optimum resources utilization and continuous up gradation of the productivity and quality of APIs through process simplification, automation, standardization & cost reduction.  File all new material concepts including process designs, syntheses, purification and characterization through invention disclosures and support patent filings as required to protect intellectual property. Period : From March 2004 to August 2005 Organization : JUBILANT ORGANOSYS LIMITED, NOIDA. Designation : Group Leader (Generic API). Responsibilities & Achievements:-  Developed process and resolved challenging polymorphic problem for Aripiprazole and preparation of stable Rabeprazole API.  Successful achievement in developing a novel non-infringing route for the preparation of entire range of bis-phosphonates mainly comprises Risedronates, Zoledronic Acid, Alendrronic Acid. Period : From July 2002 to February 2004. Organization : BIOCON INDIA LIMITED, Synthetic Chemistry Division, BANGALORE Designation : Associate Scientific Manager. Responsibilities & Achievements:-  To lead various groups of FTE based Contract Research for the Astra-Zeneca, Sweden; DuPont, USA; and Quest international, Netherlands and Kinecia, Australia along with process development of some molecules for the same companies.  Developed three API molecules and Process development for one of the important fine chemical (2,3-Dichloropyridine) for DuPont, USA. Period : From September 2001 to June 2002. Organization : KOP Research Center, Bangalore Designation : Assistant Manager – Research & Development Responsibilities & Achievements:-  To develop process for APIs and intermediates.  The main products developed are: Fluoxetine Hydrochloride, Crysanthemic Acid and Spilanthol. Period : From November 1997 to September 2001. Organization : CADILA HEALTHCARE LIMITED, Ankleshwar Designation : Senior Executive – Research & Development Responsibilities & Achievements:-  To develop process for APIs and intermediates.  First process development of Statins, Atorvastatin & Itavastatin [Pitavastatin] in India and scaled- up at commercial scale into the plant.  Process developed for Candesartan and Nelfinavir and scaled-up. Date : 16-02-2017 Place: Vadodara, INDIA (Dr. MANOJ KUMAR SINGH)
  5. 5. Page 5 of 5 Annexure -1 List of Research Publications: 1. Chirality, 23(10), 955-960, 2011. 5. Indian J. Chem., 36B, 137, 1997. 2. Indian J. Chem., 39B, 390, 2000. 6. Indian J. Chem., 35B, 920, 1996. 3. Indian J. Het. Chem., 8, 193, 1999. 7. Indian J. Chem., 33B, 1119, 1994. 4. Indian J. Chem., 38B, 920, 1999. Granted Patents: 1) Process for Preparing a Pure Polymorphic Form of 3-Pyridyl-1-hydroxyethylidine-1,1- bisphosphonic Acid Sodium Salt. WO2006051553, EP1828214, CA2590046, US200830040 2) Process for Producing Bisphosphonic Acids and Forms Thereof. WO2006134603, EP1891081, US7872144 (B2) 3) A Process for the Preparation of Pure Anastrozole. WO2007054963, US2009221837, EP1940806, 4) A Process for Preparation of Benzylbromide Intermediate. WO2007054963, US2009221837, EP2397472 5) Process for the Preparation of Letrozole. WO2007054964, EP1945618, US2010190997, IN251065 6) An Efficient Process for the Preparation of Pure Anastrozole. WO2007141799, EP2029557, US2009247765, US8058302 (B2) 7) A Modified and Efficient Process for the Preparation of Exemestane. WO2009093262, EP2231691 (B1), ES2461092, US8288571 (B2) 8) Process for Preparing of Fluticasone Propionate/Furoate. WO2012029077, EP2611821, JP2013536835, US8841442 (B2) Published PCT Applications: 1) Novel Salts of Quitiapine. WO2007102074 2) Process for Preparing Ciclesonide. WO2008015696 3) Crystalline Polymorphs of Ciclesonide. WO2008062450 4) Efficient Process For Preparation of Optically Pure Indeno[5,4-B]furan Derivatives. WO2008062468 5) An Improve Process for the Preparation of Pentosan Polysulfate. WO2012114349 More than 20 patent applications filed worldwide are under review. (Dr. Manoj Kumar Singh)