Organic Chemist

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 :-
• Providing guidance and support for process development for challenging of patents in regulated market.
• Design patent non-infringing scalable synthetic routes/process and scale-up of API’s
• Bench and Pilot scale synthesis transformations in hands on
• Optimization of the process, ie,developing industrially feasible process.
• Preparation of PDR, filing of patent and DMF
• Lead a group of Scientists and Group Leaders(for docs).
Skill sets:- Technical skills:
Synthesis:
• Development of novel synthetic routes/process for pharmaceuticals and successful implementation of the technology in pilot plant
• Conducted various reactions at laboratory and production scales.
• Synthesized various classes of compounds.
• Experienced to work under cGMP condition
Documentation:
• Literature survey: well conversant with the use of Sci Finder and Internet search techniques.
• Operating Instruction: Preparation of scale up report (process, yield, costing, quality, specification etc.).
• Setting of specifications: Supported analytical section for method development and establishment of specification for Raw Material, Intermediate and finished products.
Soft skills:-
• Creativity in problem solving, Highly motivated and Self-starting individual, Excellent communication skill,Team leader with good listening

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

joined glenmark with allround experience described in this profile

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

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 :-
• Providing guidance and support for process development for challenging of patents in regulated market.
• Design patent non-infringing scalable synthetic routes/process and scale-up of API’s
• Bench and Pilot scale synthesis transformations in hands on
• Optimization of the process, ie,developing industrially feasible process.
• Preparation of PDR, filing of patent and DMF
• Lead a group of Scientists and Group Leaders(for docs).
Skill sets:- Technical skills:
Synthesis:
• Development of novel synthetic routes/process for pharmaceuticals and successful implementation of the technology in pilot plant
• Conducted various reactions at laboratory and production scales.
• Synthesized various classes of compounds.
• Experienced to work under cGMP condition
Documentation:
• Literature survey: well conversant with the use of Sci Finder and Internet search techniques.
• Operating Instruction: Preparation of scale up report (process, yield, costing, quality, specification etc.).
• Setting of specifications: Supported analytical section for method development and establishment of specification for Raw Material, Intermediate and finished products.
Soft skills:-
• Creativity in problem solving, Highly motivated and Self-starting individual, Excellent communication skill,Team leader with good listening

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, EMAIL, amcrasto@gmail.com, 09323115463 call now

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

Carried out Synthetic Research work partly at (R&D) at RPG RESEARCH CENTRE NAVIMUMBAI- PLANT WAS AT PANOLI

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

VISITED TABLETS, LARGE VOLUME PARENTERALS, INJ, STORES ETC AS PART OF GMP TRAINING

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.

MANUFACTURING
Practical Production training in Pharmaceutical manufacturing in the following Departments.
1. Powder injectibles

2. Large Volume Parenterals (Haemaccel)

3. Small Volume Parenterals (Liquid injectibles)

4. Tablets.

CUSTOM SYNTHESIS OF API, Eg COENZYME Q10, ETC

MANY PROJECTS ON CUSTOM SYNTHESIS FOR CBZ, PFIZER, AVENTIS, ETC WERE DONE DURING THIS TENURE IN INNOVASSYNTH

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)

MULUND, Mumbai. INDIA The job involved all aspects of synthesis and commercialization from research lab to production,
PROJECTS HANDLED:
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
Intermediate)

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.)

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

DID ORGANIC PROCESS DEVELOPMENT AS A RESEARCH FELLOW

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.

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.

4years
Worked as Indian Organic; PhD programme(organic chemistry) on the topic " Synthesis of novel pyrethroids analogues". Simultaneously did project work for IOC.

GLENMARK PHARMACEUTICALS LTD. - DEC ‘05 - Presently working
API ,PROCESS RESEARCH
Currently working with GLENMARK GENERICS LTD research centre as Principal Scientist, process research (bulk actives) API) at Mahape ,Navi Mumbai,(dec05-present) 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 :-
• Providing guidance and support for process development for challenging of patents in regulated market.
• Design patent non-infringing scalable synthetic routes/process and scale-up of API’s
• Bench and Pilot scale synthesis transformations in hands on
• Optimization of the process, ie,developing industrially feasible process.
• Preparation of PDR, filing of patent and DMF
• Lead a group of Scientists and Group Leaders.
• Hands on with GC, NMR, IR, UV, HPTLC
 Technology Transfer:-
• Preparation of technology transfer document(TTD)
• Validation batches
• Timely transfer of cost effective technology for scale up and commercialization.
 Skill sets:- Technical skills:
Synthesis:
• Development of novel synthetic routes/process for pharmaceuticals and successful implementation of the technology in pilot plant
• Conducted various reactions at laboratory and production scales.
• Synthesized various classes of compounds.
 Analytical:
• Excellent skills in the operation and interpretation of analytical data from NMR, IR, UV, GCMS, HPLC, GCMS etc.
• Experienced to work under cGMP condition
 Documentation:
• Literature survey: Should be well conversant with the use of Sci Finder, MS word, MS Excel, Power point, Chem. Draw and Internet sea