DR. ANTHONY MELVIN CRASTO
PH.D (ORGANIC CHEMISTRY) from UDCT, Mumbai, 1991, with Over 23years of result oriented Experience in Industry and 4 yrs academic (total 19 years). Presently, working for GLENMARK PHARMACEUTICALS LTD as Principal Scientist, process research (Bulk activities – dec‘05 onwards)
Earlier organizations include :-
- INNOVASSYNTH Tech Ltd (2.7 yrs),
- RPG Life Sciences (5.7yrs),
- HOECHST MARION ROUSSEL (GMP dept,7 months),
- HOECHST MARION ROUSSEL (Process Devl. dept, 4 years),
- SEARLE INDIA Ltd (1.7 yrs),
- Indian Organic Chemicals Research Fellow, UDCT,Matunga,Mumbai (4 yrs,academic experience)
Personal Details :
Location : Mumbai (Thane)
Nationality : Indian
Date of Birth : 17th January, 1964
Marital Status : Married
Passport : Number E 5892109 Valid – Travelled abroad (U.K,SINGAPORE)
Postal address : Vijay Nagari Annex, Bldg.26, Flat 34
Ghodbunder Road, Thane (W)-400 601 India.
Email I.D. : firstname.lastname@example.org
Web : http://amcrasto.bravehost.com (ctrl +click to follow link)
Mobile :+91(country code)-9323115463/+91-9867053250
Ph.D – Organic Univ.Department of Chemical Technology, Matunga By Research
Chemistry – (1991) Bombay (Univ. of Bombay) India Thesis : Prof. S.Seshadri
Synthesis of Novel Pyrethroid Analogues.
M.Sc. - (Organic R. J. College, Ghatkopar, Securing 1st Class
Chemistry – (1986) Bombay (Univ. of Bombay) (65.50%)
B.Sc -.Chemistry R .J. College, Ghatkopar, Securing 1st Class
(1984) Bombay (Univ. of Bombay) (62.60%)
H.Sc (1981) R. J. College, Ghatkopar, Securing 1st Class
Bombay (Poona Board) (68.17%)
S.S.C (1979) St. Xavier`s high School, Securing 1st Class
Powai, Bombay (Poona Board) (69.29%)
1. Part time Certificate course in Basic Computer Programming from Students Computer land – Mulund Bombay (First Class)
2. Part time Certificate course in General Electronics from Bombay Inst. Of Tech. – Mulund – Bombay.
3. Postgraduate Diploma Course in Industrial and Analytical Chemistry from Ruia College – Matunga (1986-1987 – Grade A)
Course included:,Electroanalytical Technology,Microbiology,Spectroscopy,Separation Technology,Statistics,Packing,Air-water analysis,Management
4. Diploma Course in Business Management from Prin-L.N.Welingkar Inst. Of Management, Research & Development, Matunga Bombay (Aug. 1989 – 1990 – Grade A), Courses included:,Marketing Research and Advertising,Marketing Management,Personnel Management,Office Management and Administration,Managerial Economics,Financial and Cost Accounting,Industrial Law,Principles and Practice of Management,Organizational Behavior,Stores Management and Inventory Control
EXPERIENCE: (academic 1987-1991, 4years) (Industry 1991-Present, 23
1 Currently working as Principal Scientist, Process research(Bulk Actives) with GLENMARK PHARMACEUTICALS LTD research centre, API division at Mahape ,Navi Mumbai, India job involves research and development work on APIs from lab to commercial production, support for DMF filing, in the process develop novel non infringing routes and file patents,(dec05-present)
2 Worked as Sr Manager R&D with Innovassynth technologies Limited, Khopoli, India (formerly IOC ltd) and led a team of 20 chemists for the custom synthesis business in the area of drugs, organic intermediates, specialty 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.(may03-dec05----2 yrs 7 months)
3 Worked as a Manager (R&D) at RPG Life Sciences Ltd ( formerly Searle India ltd). Thane Belapur. INDIA The job involved all aspects of synthesis and commercialization from research lab to production, including third party activities. (Oct. 1997- may2003, 5 years 6 months )
4 Worked as an Executive, process development at German multinational Hoechst Marion Roussel Ltd, (NOW SANOFI-AVENTIS)Mulund, Mumbai, India in the QA dept, GMP section (Feb.1997 – oct. 1997, 8 months)
5 Worked as an Executive,QA/GMP at a German multinational Hoechst Marion Roussel Ltd, Mulund, Mumbai, India in the Process Development Team. (Jan1993 - Jan1997, 4 years)
6 Carried out Synthetic Research work as a Management trainee (R&D) at an American multinational Searle India ltd, Research and development centre, Thane, India (Now RPG Life Sciences Ltd) (May 1991 to Dec. 1992, 1 year 7 months)
7 Worked as Indian Organic chemicals research fellow at UDCT Matunga, Mumbai, for PhD programme(organic chemistry) on the topic “ Synthesis of novel pyrethroids analogues”. Simultaneously did project work for IOC.(1987-1991, 4 years)
Highlights in career
1. Selected for PH.D programme ,1987 in IIT Mumbai and UDCT, Mumbai(opted for UDCT).
2. Awarded Rs.20000/- 1992 for best performance in Hoechst Marion Roussel (HMR), MUMBAI,INDIA.
3. Involved in a successful TGA Audit in HMR 1997
4. Promoted to Executive, Process Development from Officer in HMR (1996)
5. Exported 100Kg. MAPO (RPG) 1998 to CBZ U.K. in 3 months time and later awarded a trip to U.K.
6. Promoted from Asst. Manager to Manager (RPG 2000) for commercialization of 25 tons deltamethrin, SPENT SIX MONTHS TIME IN THE PLANT and recd certificate from MD(product instrumental in a gain of 90 crores from sale to isagro limited)
7. Manufactured Raloxifene (2 kg.) in a team work in one months time to be registered in U.K. for CBZ U.K.
8. Registered Donepezil for the 1st time in India and later on manufactured 4 kg. (2002-03)
9. Involved at Innovassynth in commercialization of a dozen projects to the tune of a turnover of 60 crores in the custom synthesis business for reputed foreign clients
10. At Innovassynth contributed 2 products in the first year, guggulsterone and BTE which led to construction of a pilot plant worth 22 crores.
11. stock options:allotted 70,000 shares of innovassynth under key employee stock option
12. Attended international organic chemistry conference in Singapore on 8 dec 2005 -10 dec 2005
13. Filed 6 patents this year-2006
GLENMARK PHARMACEUTICALS LTD. - DEC ‘05 - Presently working API ,PROCESS RESEARCH Currently working with GLENMARK PHARMACEUTICALS 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 8 targets for regulated markets. Provide support to US/European marketing team for developing and execution of new projects
Ø 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 Jr.Group Leaders.
· Hands on with GC, NMR, IR, UV, HPTLC
Ø Technology Transfer:-
· Preparation of technology transfer document(TTD)
· Validation batches
· Timely transfer of cost effective technology for scale up and commercialization.
Ø Skill sets:- Technical skills:
· 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.
· Excellent skills in the operation and interpretation of analytical data from NMR, IR, UV, GCMS, HPLC, GCMS etc.
· Experienced to work under cGMP condition
· Literature survey: Should be well conversant with the use of Sci Finder, MS word, MS Excel, Power point, Chem. Draw 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.
· Risk analysis: Evaluating risk in the new business areas and synergize the team to search for alternatives/reduce/avoid risks that have to be assessed well
Ø Soft skills:-
· Creativity in problem solving, Highly motivated and Self-starting individual, Excellent communication skill,Team leader with good listening
INNOVASSYNTH TECHNOLOGIES. 2 .7 Years CUSTOM SYNTHESIS Worked as Sr Manager (R&D) with Innovassynth technologies Limited, Khopoli, INDIA (formerly IOC Ltd) a custom synthesis company catering to leading American and European Multinationals (May’03 – Dec ‘05, 2 yrs 7 months)
Headed a group and worked on approx 25 custom synthesis projects with 18 scientists /chemists and 2 literature scientists. 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.(may03-dec05----2 yrs 7 months)
Dozen projects already executed and some in pipeline waiting for commercialization in the old and new pilot plants. ( clients include Bedoukain, CCR, polyfine, Novartis, lonza, Synergy, BASF, Austin, FMC, Crompton, Semafore etc)
projects commercialized :
2 COENZYME Q10 Intermediate
3 N-(2,4 Dimethoxy phenyl) piperazine
4 2,6 -DMPI
5 Benzoic acid 4(4-propyl-1- piperazine)
6 2,4- dichloro 5- methoxyaniline
7 2- bromo hexanoic acid
10 Hexyl resorcinol
11 Several in pipeline for commercialization
12 60 samples sent for evaluation to foreign clients
RPG LIFE SCIENCES LTD. 5 Yrs/7Months API/CUSTOM SYNTHESIS Worked as a Manager (R&D) at RPG Life Sciences Ltd (formerly American multinational SEARLE INDIA LIMITED,. Thane Belapur. India. The job involved all aspects of synthesis and commercialization from research lab to production, including third party activities. (Oct. 1997- may2003, 5 years 7 months )
PROJECTS HANDLED AT RPG Life sciences ltd(Drugs, Drug intermediates,Agrochemicals, intermediates for custom synthesis)
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
3. PZL. Chloride an Multi-step process is being continuously modiied intermediate of /developed to meet cost demands.
4. Cilostazole process development development
5. Gatifloxacin Developed a process which was not commercialized due
to cheap drug available from china.
6. Raloxifene Was involved in the scale up team supporting rapid
commercialization of the drug.
7. Chiral Piperazine Developed this intermediate of indinavir
8. Int. of Glimepiride Developed 3 – ethyl – 4 methyl – 3 pyrrolidine – 2 one
1. Deltamethrin manufactured 3 tonnes 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. Later on annually about 25 tonnes were manufactured.
(Stayed in plant for a period of 6 months to complete 3 tons campaign and received award from managing director)
2. Acetamiprid Developed a process from scratch. Process was
handed over to isagro for commercialization in 2001
during hiving of the company from RPG
3. M-alcohol an During isagro transition period in 2001, the process
intermediate from Italy was adapted to Indian plant conditions,
of Tetra conazole scaled up with some modification and handed over for
commercialization. This is being produced on a regular
4. Pyrazosulfuron ethyl Developed a process from scatch. Process was handed over to isagro for commercialization in 2001 during hiving of the company from RPG.
intermediates (custom synthesis)
1. Thiol-intermediate Manufactured 2 kilos on pilot plant scale as R & D
of raloxifene demonstration. (for CBZ-U.K.)
2. TPCP Manufactured 1 kilo in lab (Aventis – Germany)
4 Phenyl – 4 Piperidine carboxylic acid tosylate(TPCP)
3. DBAP Manufactured 0.250 kilo in lab (Aventis –Germany)
Ethyl 3 (N-3,4 Dimethoxybenzyl)amino-propionate
4. MAPO Methyl aziridine phoshonium oxide 100kg. in pilot
plant (CBZ – U.K.)
5. 6 HDHQ Int. of Manufactured 0.250 kilo in lab (Davos – USA)
6. p-Triflouromethyl Maufactured 1 kg. for Rhodia – France
7. 6 MDHQ Manufactured 0.5 kg. for Davos
HOECHST MARION ROUSSEL(GMP DEPT) 7 months PHARMA Worked as an Executive with GMP/QA DEPT. in HOECHST MARION ROUSSEL LIMITED Mulund, Mumbai(1997 Feb to Oct. 1997—8 MONTHS)
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 (Haremaccel)
3. Small Volume Parenterals (Liquid injectibles)
HOECHST MARION ROUSSEL(PROCESS. DEVELOPMENT) 4YRS PHARMACEUTICALS Worked as an Executive in the Process Development Team. At HOECHST MARION ROUSSEL (Mulund, Mumbai).(now sanofi-aventis) (Jan1993 - Jan1997, 4 years)
1. Pentoxyfylline Independently developed a new route
2. Roxatidine In a team worked on some of its intermediates.
3. Deltamethrin Process developed and production trouble shooting
4. ECPPA Independently developed a 5 step route for the sythesis
of this single isomer(Enalapril/Ramipril)
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
7. Several Drugs/ Trouble shooting for production (e.g. Pitofenone HCI
Frusemide Ramipril etc.)
SEARLE INDIA LIMITED ( R & D DEPT) 1yr/7 months PHARMA Worked as management trainee at SEARLE INDIA LIMITED(American multinational) (May 1991 to Dec. 1992, 1 year 7 months)(Drugs and Natural products )
RESEARCH GROUP :
Worked with Dr.K. Nagarajan and Dr. (Mrs.) S.J. Shenoy
1. Azathioprine Partially workded on all the steps without having
much exposure on the projcect
2. Cis – Menthadienol In a team worked on a 6 step stereospecific
3. Trans-Menthadienol In a team isolated it from Ginder grass oil in its
4. Olivetol In a team worked on its 3 step synthesis
5. Iothalamic acid In a team worked on its process development
6. Diatrizoic acid In a team worked on its process development
7. Iopamidol In a team worked on its process development
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.
2) 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.
3) Worked as a technology transfer man and provide all data required for transfer from lab to commercialization.
4) Assist in stability studies/impurity profiles/dossiers and act as a coordinator between lab and commercial production. Also required to synthesize some impurities in pure form to meet the dossier demands.
5) Complete command for use of computer, ability to use all programs( word,excel,powerpoint) and no need for secretarial assistance.
6) Use of Internet and manual literature search methods to decide the synthetic strategy and upgrading of literature information for existing entities. Well versed with CAS scifinder program for literature search. Also having the ability to look for free information on the web( patents, etc). well versed with use of a german program for lit search ie spresiweb,ability to handle programs like integrity etc
7) Use of modern spectroscopy/analytical methods to monitor the synthetic scheme.
8) Guide a team of chemist/technologists during commercialization.
9) Use of GLP/GMP wherever required i.e. lab, pilot plant, plant and maintain documentation as per norms applicable.
10) Assist the technologist during unit operations during manufacture.
11) Strictly follow the safety norms, educate and implement the safety
Procedure as per norms, conduct hazop studies.
12) Training and development of fresh chemists and up-gradation of skills of existing ones, Maintain a cogenial atmosphere for the team and encourage team work.
13) Finally look for excellent standards of working, which will minimize reworks / cost and maximize output.
14) Excellent ability to understand and communicate to foreign customers via email, documents and telephone. Maintain good documentation in this respect. Excellent presentation skills for presenting to top management or clients.
15) Ability to work with original inventor in US and the drug company needing the final product in Europe, eg coenzyme q10 . Interact with both of them and produce results acceptable to both.
16) Maintain confidentiality and stick to the agreement.
17) 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
18) Ability to develop novel routes for API,s and draft patents,well versed with polymorphism issues