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[QUOTE=Guest-IJT;136102][b]Name [/b]: siddharth ambekar
[b]Email [/b]: siddharth_ambekar AT indiatimes.com
[b]Designation / Skillset[/b] : Sr. Executive API-R&D Process development
Dear Sir/Madam,
I like to inform you that I’m very much interested to join your esteemed organization in R&D -API Process development /Kilo lab/Technology transfer or Quality Assurance -Compliance,
since I have nearly 8-10 years of experience in R&D API- Process development and Technology transfer of Overseas Projects / Site inspections for Contract manufacturing/ Raw materials procurements and handling Purchase, Cost sheet evaluations , where I am made to understand that opportunities, of growth are provided.
Also I worked for reputed companies like Rallis research centre India,Bangalore, Cipla Ltd.,Bangalore and Piramal Healthcare Research centre ,Goregaon,Mumbai as PDG –R&D-Research scientist and presently i'm working as Team leader in API R&D Process development -Tech Transfer in M/s Ajanta Pharma,Advent Research centre in Kandivali,Mumbai.
Be pleased to find herewith, enclosed, my Curriculum Vitae for your kind perusal.
Given an opportunity, to serve, I am confident, that I would be able to fulfill my responsibilities to the best of my capabilities.
I would be earnestly grateful, if given an opportunity to meet you in person.
Awaiting a positive response, I remain, 
Thanking You
Truly yours,
Siddharth Ambekar
Thane-Mumbai
[b]Contact no [/b]: 9594188228
[b]Mail Id [/b]: siddharth_ambekar AT rediffmail.com

[u][b]Resume[/b][/u] :
R E S U M E SIDDHARTH S. AMBEKAR
 siddharth_ambekar AT rediffmail.com 
 
 
======================================================================
Seeking a Middle Management assignment as…
Asst.Manager / Manager- ( R&D API-Process development Scientist –Tech. transfer /Quality Assurance -Compliance) in the…
PHARMACEUTICAL / BIOTECH industry
A capable and committed Research Scientist with MSc in chemistry and over 10 years of experience in the pharmaceutical industry as Senior Research scientist - R&D / Technical with excellent organizational team management skills and highly achievement oriented with strong knowledge base and keen on continuously upgrading knowledge.
STRENGTHS
- Ability to generate ideas and use technical expertise to bring them to fruition.
- Strong communication and coordination skills with ability to lead teams of chemists effectively.
- Adaptable with strong will power and perseverance in aggressively pursuing goals.
- Organized and methodical capable of planning and prioritizing work to utilize resources optimally.
TECHNICAL EXPERTISE
- Excellent training and experience in Organic synthesis –Process development ,Scaleup characterization and Technology Transfer to Pilot plant, Kilo lab and bulk drug plant for commercialization.
- Synthesis, Separation, Purification and Spectral analysis of Organic compounds using spectroscopic methods, column chromatographic methods, Vacuum distillation and steam distillation.
- Skilled in conducting literature search through chemistry related software and good in theoretical cost calculations.
- Highly experienced in Process development including validation of methods - Successfully executed high volume low cost and low volume high cost Projects.
- Good in preparing Research reports and manuscripts as well as documents for Validation and Technology Transfer of Overseas-CRO based Projects.
- Identification of API’s as per market potential its commercial value to obtain Drug licence from FDA for manufacturing of API’s with 3rd parties on Loan licence.
- Preparation of CDA and MoU draft to get Contract manufacturing of API’s products and procurement of process Technology from Overseas..
- Selection of Product Specification and Preparation of Specification as per supplier demands.
[b]EXPERIENCE PROFILE [/b]:
1. Sr. Executive / Team Leader (R&D API- Tech.-Transfer) since Oct.’2010 to till date in M/s AJANTA PHARMA LTD., Advent Research Centre, Charkop (W), MUMBAI.
[b]Nature of Job [/b]:
Job responsibilities include handling of short term API projects , Bench Scale up of R & D batches, Process Optimisation, characterization, Process development, Vendors selection for Key Raw materials, Process validation and Commercialization, PDR Preparation, Trouble shooting of Plant batches, Cost evaluation of process . Lab Process Demonstration and process familiarization, coordinate with R&D scientist and their team for their Technology Transfer of robust process to Bulk drug Plant. Also have competency in modification of API product process for DMF and In-house bulk manufacturing of API’s for In-house Formulation development and Documentation for DMF filing and Submission to WHO and Regulatory authorities.
2. ASST. MANAGER (Manufacturing & Technical Dept.) since July.’2009 to till date in m/s G.C. CHEMIE PHARMIE LTD., ANDHERI (W), MUMBAI.
[b]Nature of Job [/b]:
Job responsibilities include identification of API products and its market potential, development of process from N-1 Intermediate and procurement of Technology from overseas also from Indian companies on signing legal agreements like CDA and MoU, Contract manufacturing with third parties on loan license basis by obtaining Local State FDA Manufacturing license for API‘s manufacturing in different companies bulk drug Plant ,Recently I obtain Manufacturing Licence for one of the API manufacturing from state like FDA-Gujarat and for other products from Maharashtra and other states..
Identification of manufacturing sites throughout in India on the basis of Product manufacturing requirements and on Equipments suitability for contract manufacturing /Job work.
Prior to that API’s complete market analysis, import/export data analysis. Preparation of Product Cost sheets as per competitive market prices. Procurment of Raw materials, key intermediates, Understanding of process chemistry, Demonstration of Process on pilot plant and directly on commercial stage.
Presently handling Antiasthmatic MDI products and looking for manufacturing kilo labs from N-1 intermediates to API.
Backward integration of process to make cost effective product. Recently manufactured Diphenhydramine HCl on Loan licence basis in Ankleshwar, Gujarat
Sample submissions to Domestic companies like Lupin, Cipla, IPCA for approval, and its stability studies and data generation for supplier. More to understand the commercial value of API products in competitive market.
Objective behind Job work/contract manufacturing and its Technology transfer from overseas to Local market to make company brand name from Trader to API’s Manufacturer.
3. RESEARCH SCIENTIST (Process Development Group - R&D) from Oct.’2003 to June ‘2009 in m/s PIRAMAL HEALTHCARE LTD., Goregaon, Mumbai.
[b]Nature of Job [/b]:
Job responsibilities include handling of short term API projects, Bench Scale up of R & D batches, Process Optimisation, characterization, development, Validation and Commercialization. Process familiarization study of Contract Manufacturing Project or CMG-Projects of GSK, Merck, 3 M sante Co, Roche..
Characterization of Organic compounds using spectroscopic techniques such as NMR, MS, and IR spectroscopy as well as experience with separation techniques including HPLC and GC; Ability to apply basic scientific/technical knowledge and with general guidance from supervisor and also ability to design, conduct, execute and interpret data from Lab experiments.
Documentation, day to day planning, Resource planning, Patent searching, literature survey, preparation of Technical Transfer Data for plant designing, commissioning and Technology transfer to Kilo lab, Plant scale commercial production.
Project handles Like Oxybutynin HCl, FADCP intermediate for Abacavir, Flacanide acetate, Tolcapone, Iohexol and Quetapine fumarate.
Familiar with E-note book, online samples generation (LIMS), Trouble shooting, Work as per good laboratory standard in accordance with company practice and COSHH / SHE legislation.
4. PRODUCTION OFFICER (R & D- Pilot plant/Bulk drug Plant) from July’2000 to Sept.'2003 in M/s CIPLA LTD., Bangalore.
[b]Nature of Job [/b]:
Job responsibilities include development and scale-up of safe and efficient chemical processes for the preparation of pharmaceutical intermediates. Handling of R & D trial batches in bulk drug - pilot plant, Production of some basic drug (API) like OMEPRAZOLE, TOPIRAMATE, GABAPENTINE, and CTVA (Vinca Lab) in bulk drug manufacturing plant. Also handling documentation of non-DMF, DMF, SOP'S, exposure to SAFETY norms, cGMP, GLP.
5. RESEARCH FELLOW from April'00 to July'00 in m/s RALLIS INDIA LTD., Bangalore, Rallis Research Centre (The TATA Enterprises), presently called as Hikal Limited Bangalore.
[b]Nature of Job [/b]:
The job responsibilities include Development of Organic molecules in Synthetic labs, Kilo Lab and handling of trial batches in Kilo lab,Pilot plant and Scale up in bulk drug manufacturing plant.
6. R& D-CHEMIST from May ‘99 to March '00 in m/s SHRISHMA FINE CHEMICAL & PHARMACEUTICALS (K) LTD., Doddaballapur Industrial Area, Bangalore.
[b]Nature of job [/b]:
The job responsibilities include modification of Bulk drug Plant batch process and Scale up of some basic drug like DPX .HCL (Diphenoxylate hydrochloride) and Intermediates.
[b]ACADEMIC BACKGROUND [/b]:
- D.HRD from National open school of management studies, Chennai in 1998 (Part time Course). 
- M Sc. (Physical Chemistry) from Institute of Science, University of Nagpur, in 1997. 
- B Sc. (Chemistry, Zoology & Botany) from Institute of Science, Nagpur University in 1995.
- 12Th (AISSCE) from Kendriya Vidyalaya School, CBSE, New Delhi in 1992.
- 10Th (AISSE) from Kendriya Vidyalaya School, CBSE, New Delhi in 1990.
 
[b]COMPUTER LITERACY  [/b]:
Familiar with MS-Dos, Win-XP, MS-Word, Power point, Excel, Chem draw, Patent search, Sci-finder and LIMS.
[b]AREA OF INTEREST [/b]:
Process Development of API’s in R & D Lab and Technology transfer to Bulk drugs plant, Contract Research and Manufacturing of API products for Domestic and for Overseas market and also in Quality assurance –Compliance.
[b]EXTRA CURRICULAR INTEREST [/b]: 
 
 * Literacy & Culture forum Executive member of Institute of Science, Nagpur.
 * Joint Secretary of Chemical society, Institute of Science, Nagpur.
* Steering Committee member of Institute of Science, Nagpur.
* Training on c-GMP by eminent personality Dr.Nitin Shilgaokar,Pune consultant.
* Training on Personality development by Cipla Limited, Bangalore.
 * FDA (Gujarat) approved -Chemist for manufacturing of API’s.
 
 
[b]REFERENCES [/b]:
 
 * Dr.Sivaramakrishnan (R&D -President)
 M/s Piramal life sciences ltd.,
 1-A,1-B & 1-C, Nirlon complex,
 Opp. Western express high way,
 Goregaon (East), Mumbai– 400063
 
 [b]mail Id [/b]: h.sivaramakrishnan AT piramal.com
 * Mr.Pravin karnik ( Director, Custom Synthesis)
 M/s Anant Pharmaceutical Pvt.Ltd.,
 Ambernath, Dist. Thane
 Maharashtra, INDIA 421501
 Ph.no.9322310064 (P) 
 * Mr.C.Manjunatha (Production Head -Bulk drug)
 M/s Cipla limited, 
 Virgonagar,old madras road,
 Bangalore –560049 
 
 [b]mail Id [/b]: c.manjunatha AT cipla.com 
 * Mr. A.V Kutumbe (Unit Head)
 M/s Cipla Ltd.,
 LBS Marg, Near Station,
 Vikhroli (West), Mumbai-40079
 
 [b]Mail Id [/b]: av.kutumbhe AT cipla.com
 
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[b]More Information about this submission and submitter [/b]:-
___________________________________________________
[b]Submission ID  [/b]: 4351566
[b]Date & Time  [/b]: 9th Jul 2011 5:20 PM (UTC)
IP Address : 121.245.142.229
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Predicted Country : India[/QUOTE]

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