Curriculum Vitae :
Anil C. Mali, Ph. D.
E-Mail : anilcmali97 AT gmail.com
Mobile : 09860292304
Objectives :
To fulfill my professional and carrier aspirations by aligning my vision with organizational goals and vision
Professional Snapshots :
** A result oriented professional with a proven track record of more than 11 years in process research of API/Intermediates, process enhancement and quality assurance.
** Expert to investigate the cause for observed OOS, OOT, deviation/ handling QMS.
** Process validation
** Adept in developing new chemical processes for product development
** Proficiency in enhancing the process operations; thereby achieving the required quality level of the products
** Skilled in common laboratory techniques
** Published more than Nine (9) research articles in peer reviewed international journal.
** Filed more than three (3) patent applications and few are under process of filing.
Educational Qualifications :
** Ph. D. [Process Research and Development of Active Pharmaceutical Ingredients (API) and Synthesis and Biological Evaluation of Novel Oxazolidinone Derivatives] : KTHM college, Nasik, Pune University; 2018
** M. Sc [Organic Chemistry] : RYK College Nasik, Pune University; 2006
** B. Sc [Chemistry] : North Maharashtra University; 2004.
Employment History :
** Oct. 2017- till date : Quality Assurance department, Megafine Pharma Pvt. Ltd. (Nashik)
** 2007-till date : Megafine Pharma Pvt. Ltd. (Nashik)
Project Leader, steering the process research activities for end to end development of API
Job responsibilities :
** Literature survey
** Selection of route of synthesis
** Designing non-infringing route
** Feasibility study of selected route
** Optimization of the process,
** Impurities preparation,
** Polymorph screening and developing the process for the preparation of target polymorph as well as novel polymorphs
** Lab-validation of the optimized process,
** Drafting of patent applications,
** Preparation of technology transfer document,
** Transfer of scaled-up process to manufacturing facility without any issues till finalization of the process validation
2006 -2006 : Mangalum Drugs Ltd. (Vapi)
Research Associate at Mangalum Research Center, Mangalum Drugs Ltd, Vapi
Core Competencies :
** End to end Development of cost effective, safe and environment friendly processes for APIs for regulated and less regulated markets (infringing and non-infringing processes)
** Meeting the quality parameters of the APIs as per ICH guidelines
** Ensuring stringent adherence to quality standards, norms and practices
** Ensure compliance of various quality measures such as GLP by maintenance of appropriate documentation and records
** Preparation and evaluation of Development History Reports
** Transferring of the process to the plant with all technical packages
** Demonstration of the process at plant
** Development of cost efficient processes for new chemical entities (NCEs)
** Polymorph screening
** Patent-evaluation and drafting of patents
** Co-ordination with Intellectual property department, Analytical research and Development, production for the end-to-end development and scale up of the molecule
** Assisting with all the data needed for US and Europe DMF & EDMF filings
Personal Details :
Date of Birth and Citizenship : 5th Dec.1984, Indian.
Current Address : Flat No.
6-B, Pooja darshan society, navrang colony, jail road, Nasik road, Nasik 422101, (Maharashtra)
Permanent Address : Flat No. 6-B, Pooja darshan society, navrang colony, jail road, Nasik road, Nasik 422101, (Maharashtra)
Research Publications :
1. Practical and Green Process for the Synthesis of Ivabradine Hydrochloride through an Efficient Control of Process Impurities. Mali, Anil C.; Mathad, Vijayavitthal T.; Deshmukh, Dattatray G.; Medhane, Vijay J. Current Green Chemistry, 4 (10), 151-160, 2017.
2. Practical synthetic approach to related substances of Rivaroxaban; an anticoagulant drug substance. Anil C. Mali, Dattatray G. Deshmukh, Vijay J. Medhane, Vijayavitthal T. Mathad. Res.J.chem.sci., 7 (5), 38-45, 2017.
3. First Direct Isolation of Stable a-Form Crystals of Mirabegron, a Selective ß-3 -Adrenoceptor Agonist. Dattatray G. Deshmukh, Mukund N. Bangal, Anil C. Mali, Vijay J. Medhane and Vijayavitthal T. Mathad. Acta Chim. Slov.64, 461–466, 2017.
4. Facile approach for the synthesis of rivaroxaban using alternate synthon : reaction, crystallization and isolation in single pot to achieve desired yield, quality and crystal form. Anil C Mali, Dattatray G Deshmukh, Divyesh R Joshi, Hitesh D Lad, Priyank I Patel, Vijay J Medhane and Vijayavitthal T Mathad. Sustain Chem Process 3:11, 2015.
5. Stability Indicating RP-HPLC Method for the Determination of Dronedarone Hydrochloride and Its Potential Process-Related Impurities in Bulk Drug and Pharmaceutical Dosage Form Shashikant B. Landge, Sanjay A. Jadhav, Kapil P. Nimbalkara, Anil C. Mali, Vijayavitthal T. Mathad. AJAC, 4 (6), 323-335, 2013.
6. An Improved and Efficient Process for the Production of Dronedarone Hydrochloride, an Antiarrhythmia Drug. Anil C. Mali, Sharad S. Ippar, Mahendra B. Bodke, Nilesh S. Patil, and Vijayavitthal T. Mathad. Org. Process Res. Dev., 17 (5), 863-868, 2013.
7. Efficient and Single Pot Process for the Preparation of Enantiomerically Pure Solifenacin Succinate, an Antimuscarinic Agent. NC Niphade, KM Jagtap, AC Mali, PV Solanki, MN Jachak, VT Mathad. Monatshefte fuer Chemie, 142(11) :1181-1186, 2011.
8. An Improved and Single Pot Process for the Production of Quetiapine Hemifumarate Substantially Free from Potential Impurities. Navnath C. Niphade, Anil C. Mali, Bhushan S. Pandit, Kunal M. Jagtap, Sanjay A. Jadhav, Madhukar N. Jachak and Vijayavitthal T. Mathad. Org. Process Res. Dev., 13 (4), pp 792–797, 2009.
9. An Improved and Efficient Process for the Production of Donepezil Hydrochloride : Substitution of Sodium Hydroxide for n-Butyl Lithium via Phase Transfer Catalysis. Navanath Niphade, Anil Mali, Kunal Jagtap, Ramesh Chandra Ojha, Pravinchandra J. Vankawala and Vijayavitthal T. Mathad. Org. Process Res. Dev., 12 (4), pp 731–735, 2008.
Paper presented (poster) / Symposium / Conferencee attended :
** 6th International Science Congress, “International Science Community Association”, 8th & 9th December, 2016, Hutatma Rajguru Mahavidyalaya, Rajgurunagar, Pune, Maharastra, India. (Poster Presented)
** 104th Indian Science Congress Association, 3rd to 7th January, 2017, S. V. University, Tirupati, India. (Paper presented)
Patent filled and published :
1. A process for the preparation of Vildagliptin and its intermediate thereof, WO2013179300 A2.
2. A process for preparation of rivaroxaban and intermediates thereof, WO2013121436A2.
3. Method for the preparation of Solifenacin and intermediate thereof, US Patent 8,283,470, 2012.
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