Principal Scientist, Glenmark Generics Ltd at Glenmark Generics Ltd.
Currently working with GLENMARK GENERICS LTD research centre as Principal Scientist, process research (bulk actives) at Mahape ,Navi Mumbai,and leading a team of scientists in developing APIs for regulated markets, this involves visualization and execution of novel routes, polymorphs, and developing intellectual property to protect the invention. This involves all aspects of synthesis in lab and commercialization on plant , support for DMF filing.
Currently, involved in development of several targets for regulated markets. Provide support to US/European marketing team for developing and execution of new projects
Process Development :-
o Providing guidance and support for process development for challenging of patents in regulated market.
o Design patent non-infringing scalable synthetic routes/process and scale-up of API's
o Bench and Pilot scale synthesis transformations in hands on
o Optimization of the process, ie,developing industrially feasible process.
o Preparation of PDR, filing of patent and DMF
o Lead a group of Scientists and Group Leaders(for docs).
Skill sets:- Technical skills:
o Development of novel synthetic routes/process for pharmaceuticals and successful implementation of the technology in pilot plant
o Conducted various reactions at laboratory and production scales.
o Synthesized various classes of compounds.
o Experienced to work under cGMP condition
o Literature survey: well conversant with the use of Sci Finder and Internet search techniques.
o Operating Instruction: Preparation of scale up report (process, yield, costing, quality, specification etc.).
o Setting of specifications: Supported analytical section for method development and establishment of specification for Raw Material, Intermediate and finished products.
o Creativity in problem solving, Highly motivated and Self-starting individual, Excellent communication skill,Team leader with good listening
Principal scientist, GLENMARK PHARMACEUTICALS LTD research centre at Glenmark Pharmaceuticals
RESEARCH ACTIVITIES COVERED IN THE ENTIRE CAREER
1) Extensive range of chemistry and scale of manufacture from laboratory, scale up laboratory, pilot plant, plant scale including third party activity.
Applied intellectual and synthetic skills to the process development of pharmaceutical drugs/their intermediates, and natural products, neutraceuticals, mettalocenes, speciality chemicals, flavours and fragrances in the laboratory and monitor them during plant trials.
Act as a technology transfer man and provide all data required for transfer from lab to commercialization.
Use of Internet and manual literature search methods to decide on non infringing route
Write DHR for API before implementation of novel route in the plant and assist for all batches for the DMF purposes, very well versed with IPR issues
Ability to develop novel routes for API,s and draft patents,well versed with polymorphism issues.several patents filed in US/EU
total exp23+ in industry, Currently working as principal scientist and leading a team of scientists in developing APIs for regulated markets, this involves novel routes, polymorphs, and developing intellectual property to protect the invention. This involves all aspects of synthesis and commercialization and assist in providing support for DMF filing.
Currently involved in development of several targets for regulated markets. The job involves visualization of novel routes and its execution , simultaneously develop intellectual property and generate data in the process,. Provide support to US/European marketing team for developing and execution of new projects
EX Hoechst Marion Roussel(SANOFI AVENTIS), RPG Life Sciences,Innovassynth, SEARLE,AGREVO,IOC at Glenmark Generics Ltd.
joined glenmark with allround experience described in this profile
Sr Manager R&D or Group principal scientist at INNOVASSYNTH TECH LTD
May 2003 - November 2005
led a team of 30 chemists for the custom synthesis business in the area of drugs, organic intermediates, speciality chemicals, flavours and fragrances, nutraceuticals and mettalocenes. (25 projects) This included rapid development, scale up and commercialization as per the needs of the foreign clients with a time frame.customers were Sandoz Basel, BASF Germany
Manager, research and development, API,RPG Life sciences ltd (formerly American multinational SEARLE at RPG Life Sciences
October 1997 - May 2003
1 Donepezil : Manufactured 4 kilos on pilot plant scale as R & D demonstration, the process was developed from scratch. Plans are to make 25 kilos with 300% profit margins
2) Pantoprazole : Process is being modified continuously to cope-up with price crash
3) PZL Chloride an intermediate of Pantoprazole : Multi step process is being continuously modified / developed to meet cost demands
4) Manufactured 3 tonnes deltamethrin on plant scale as R & D demonstration at an commercially viable cost, the process was developed from scratch ie lit,lab work, scale-up, pilot trials and also included third party work for one bromination step,which needed 8 reactors. Later on annually about 25 tonnes were manufactured. later on the company was taken over by a multinational for deltamethrin. the price in market crashed to half.
5) Acetamiprid : Developed a process from scratch. Process was handed over to isagro for commercialization in 2001 during hiving of the company from RPG
6) M-alcohol an intermediate of Tetra conazole : During isagro transition period in 2001, the process from Italy was adapted to Indian plant conditions, scaled up with some modification and handed over for commercialization. This is being produced on a regular basis.
7) Pyrazosulfuron ethyl : Developed a process from scratch. Process was handed over to isagro for commercialization in 2001 during hiving of the company from RPG
MANY PROJECTS ON CUSTOM SYNTHESIS FOR CBZ, PFIZER, AVENTIS, ETC WERE DONE DURING THIS TENURE IN RPG LIFE SCIENCES
Manager, R &D-sister concern of RPG--1 MONTH, ISAGRO INDIA PVT LTD-- AN ITALIAN MULTINATIONAL at Isagro S.p.A.
January 2003 - February 2003
Carried out Synthetic Research work partly at (R&D) at RPG RESEARCH CENTRE NAVIMUMBAI- PLANT WAS AT PANOLI
7 MONTHS ONLY WITH GMP/QA DEPT AND REPORTING TO GMP HEAD , ASIA PACIFIC at HOECHST MARION ROUSSEL
April 1997 - October 1997
QUALITY ASSURANCE/GOOD MANUFACTURING PRACTICES
1. Exposure to GMP in Bulk drugs and Formulations
2. Excellent Computer literacy.
3 Prepared Drug master files and Site master files for submission to Foreign
and Local regulatory bodies.
4. Conducted Process validations of Bulk drugs.
5. Exposure to cleaning validations.
6. Reviewing of SOP's for different departments.
7. Reviewing of MFR's and BMR's
8. All aspects of documentation with respect to GMP guidelines.
9. Involved in a successful preparation for an audit by the Australian
regulatory body." Therapeutic Goods Administration (TGA) "
10. Similar involvement with a WHO audit of formulations
11. Conducted several GMP audits.
12 Conducted several Vendor assessments.
Practical Production training in Pharmaceutical manufacturing in the following Departments.
1. Powder injectibles
2. Large Volume Parenterals (Haemaccel)
3. Small Volume Parenterals (Liquid injectibles)
Executive BULK DRUG QA for short time at German multinational Hoechst Marion Roussel Ltd [ at HOECHST INDIA LIMITED
April 1997 - October 1997
VISITED TABLETS, LARGE VOLUME PARENTERALS, INJ, STORES ETC AS PART OF GMP TRAINING
CUSTOM SYNTHESIS at BASF
March 1997 - May 1997
CUSTOM SYNTHESIS OF API, Eg COENZYME Q10, ETC
PROJECTS HANDLED IN CUSTOM SYN AREA at Sandoz
March 1997 - May 1997
MANY PROJECTS ON CUSTOM SYNTHESIS FOR CBZ, PFIZER, AVENTIS, ETC WERE DONE DURING THIS TENURE IN INNOVASSYNTH
Executive process development for short timeHOECHST SCHERING AGREVO a sister concern of HMR, at HOECHST SCHERING AGREVO
February 1997 - May 1997
PROCESS DEVELOPMENT OF AGROCHEMICALS FOR VERY SHORT TIME SINCE THIS COMPANY WAS A SISTER CONCERN OF HOECHST MARION ROUSSEL AND REPORTED TO DR RALPH STAPEL,DIRECTOR PROCESS DEVELOPMENT(ANILOPHOS, DELTAMETHRIN, TEFURAMETHRIN)
Exec proc.development pharmaceuticals, Hoechst Marion Roussel, now Sanofi Aventis at sanofi-aventis
January 1993 - January 1997
MULUND, Mumbai. INDIA The job involved all aspects of synthesis and commercialization from research lab to production,
1.Pentoxyfylline : Independently developed a new route
2.Roxatidine : In a team worked on some of its intermediates; Process development and production trouble Shooting
4.ECPPA : Independently developed a 5 step route for the
synthesis of this single isomer (Enalapril/Ramipri
5.Furamethrin Alc : Independently developed a commercially viable route for its manufacture involving Acetylene as the raw material.
6.Tefuramethrin : Independently developed its synthesis for M/S
Diannihon Jochugiko Japan.
7. Several Drugs/ Vet.Drugs : Trouble shooting for production (eg. PitofenoneHCl, Frusemide, Ramipril, etc.)
PROJECTS HANDLED as Management Trainee Research and devl. SEARLE INDIA LTD at Searle
May 1991 - December 1992
1 year 7 months)
(Drugs and Natural products )
1) Azathioprine :worked on all the steps. ALSO WORKED ON CANNABINOID DRUGS, OLIVETOL, worked on menthadienol, iohexol, x ray contrast agents
ORGANIC process development, INDIAN ORGANIC CHEMICALS, KHOPOLI, INDIA at INDIAN ORGANIC CHEMICALS
January 1987 - April 1991
DID ORGANIC PROCESS DEVELOPMENT AS A RESEARCH FELLOW
Ph. D research fellow at Institute Of Chemical Technology
January 1987 - April 1991
4years) (Industry 1991-2010, 19 years) total=23+ yrs
Worked as Indian Organic; PhD programme(organic chemistry) on the topic " Synthesis of novel pyrethroids analogues". Simultaneously did project work for IOC.