ANALYTICAL DEVELOPMENT SUPERVISOR Resumes in India: ISMAIL

ANALYTICAL DEVELOPMENT SUPERVISOR Resume

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ISMAIL

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India

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ANALYTICAL DEVELOPMENT SUPERVISOR

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Objective:

Seeking a challenging dynamic position in Pharmaceutical Industry that emphasizes Innovation and creativity, where my knowledge, skills and background related to Formulation and Analytical Development Sciences can be utilized for New Product Development and will enriched with time.

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Saudi Pharmaceutical Industries & Medical Appliances Corp., (SPIMACO ADDWAEIH), KSA

 Responsible for development of analytical testing method for new raw materials and their approval.
 Supervising and guiding for new analytical testing method development activities for complete analysis of all the new pharmaceutical products in various dosage forms.
 Responsible for development of stability indicating analytical methods for drug products.
 Review of analytical test reports for in-process development lots, stability batches, test & reference samples and preparation of Certificate of Analysis of finished products for registration purpose.
 Responsible for quality of documents and test results generated by the analytical development team.
 Responsible for generation of In-vitro drug release profile for test and reference products in different media to establish in-vivo performance indicative of the test product for Bioequivalence study purpose.
 Guiding subordinates for write-up of analytical method & designing of method validation protocols.
 Leading for performance of validation study and preparation of validation reports for assay, Impurities, RS, dissolution test method using HPLC, TLC, GC, UV, dissolution and other analytical techniques.
 Responsible for preparation of quality control test methods, sampling instruction, designing of In-process, release, shelf life & purchase specifications for both raw materials and finished products.
 Provide justification for set specifications for raw materials & finished products based on ICH/FDA/EMEA & other regulatory guidelines, stability data, compendia monographs and available technical dossiers.
 Responsible for Analytical Technology Transfer of new products from Dev. Lab. to QC laboratory.
 Aid the formulation development team with performance of formulation studies, specifically related to testing formulation development samples, evaluation of formula, testing of excipients, compatibility of excipients etc.
 Evaluation of stability performance of new drug products in conjunction with Formulation Development Supervisor, Packaging Development Supervisor, Technical Services Supervisor and PDTSC Manager.
 Liaison for writing, checking and reviewing of Test Method Protocols, Method Dev. Plan, SOPs, Technical Reports, Process Validation Protocols and Reports, Stability Testing Protocols and Reports, Progress Reports and their revision and approval as appropriate.
 Responsible for Qualification & maintenance of in-house working standards, design and/or implementation of strategy for their characterization & assigning of its expiration dating.
 Monitoring & scheduling activities for calibration and maintenance of all lab instruments.
 Handling of change control & investigations, troubleshooting, recommends for corrective action and implementation of solutions pertaining to analytical methodology, finished product process, characteristic and quality and demonstrated ingenuity in resolving problems
 Responsible for development of alternative supplier/vender for cost effective scheme as well as to ensure continued supply of all the raw materials.
 Handling activities related to shelf-life extension of existing products.
 Evaluation of licensor technical dossier for their suitability and verification of analytical test method
 Additional responsibilities for supervising of registration files preparation activities for submission to Ministry of Health (K.S.A.), GCC, Middle East & African countries for new product registration purpose.
 Overall responsible for new biological products (e.g. Insulin & Erythropoietin) and handling activities like development, coordination, planning, preparation of study progress & status reports and action plan. Lead the team to achieve targeted milestones and all outcomes in a timely and efficient manner.
 Demonstrated corporate values in the performance of the work and managed stronger relationships with internal customer’s thorough good communication for the timely delivery of the new projects.
 Recommend strategy and action plan with respect to development of projects to manager.
 Managed the Pharmaceutical Development Center during absence of manager.

05/2005 – 12/2005 Development Specialist,
PDTSC Dept., SPIMACO ADDWAEIH, KSA

 Supervising the formulation & analytical development activities for new pharmaceutical products like Tablets, Capsules, Dry syrup, Ointments, Creams, Suppositories, Antiseptic and Aseptic preparation.
 Guiding for and reviewing of new product registration files & evaluation of licensor Know-how files.
 Replying technical queries made by various regulatory bodies during new product registration.
 Responsible for development and/or implementation of new analytical methodology and demonstrated expertise in chromatographic method development and method validation.
 Planning and execution of technology transfer activities of different dosage form from formulation and process development to commercial production.
 Maintains properly documented records of experimental results and associated records. Submits progress reports as appropriate and assists in the preparation of study reports.
 Guide a team on preparation of regulatory requirements pertaining to analytical and stability components for regulatory submissions.
 Lead a team of analytical scientists working on method development on variety of projects and dosage forms including drug substance, immediate and modified release formulations, syrup, suspension and aseptic products.
 Work alongside Product Development Teams to provide guidance and influence around analytical methods, stability programmed design and analytical strategy.
 Preparations of necessary documents require for scale-up and manufacturing batches for the new products of different dosage form in production area (shop floor).
 Assisting QC, production and formulation development team on trouble shooting activity.
 Development of cost effective formulation for existing products.
 Provide training to new development and QC analysts on various analytical techniques / new method development in accordance with all established regulatory, compliance and safety requirement, drive analytical laboratory compliance with cGMP/GLP and ICH/FDA guidances.
 Ensure compliance is maintained in all areas of responsibility.
 Acts as internal technical consultant/advisor and provides expertise/support to projects related to new drug product development.
 Performs addition related duties, as assigned, in accordance with the job responsibilities and necessary department objectives.

10/2001 - 04/2005 Research Scientist, Pharma Research Division, Wockhardt Research Center, Aurangabad, INDIA

 Responsible for development, optimization and scale-up of synthesis of biodegradable homopolymers and copolymers based on lactide, glycolide and ethylene glycol for controlled release formulation.
 Purification and characterization of synthesized polymers by means of recent advance technique.
 Process development for sterile polymer synthesis and its validation.
 To guide for the selection of various polymer for controlled release oral formulation
 Evaluation of in-vivo and in-vitro degradation profile for biodegradable polymers.
 Preparation and implementation of protocols for stability study of polymer, API and final formulation.
 Preparation and implementation of protocols in conjunction with biology department for biodegradation studies of placebo and drug containing microspheres in Sprague-Dawley rats.
 Selection of tailor made biodegradable polymer to achieve desired release profile.
 Part of team involved in controlled release formulation of water soluble and water insoluble anticancer drug molecules in the form of microspheres and gelled dispersion systems.
 To study the assay, drug loading, release kinetics and efficacy of peptide drug from the finished products using HPLC technique.
 HPLC/GPC method development and validation for Assay and impurities for various molecules.
 Worked as a team member responsible for development of various injections for regulated market.
 Worked as a team member responsible for preparations of stability protocol, BMR, technology transfer dossier and development report for ANDA injection projects.

3/2001 – 10/2001 Senior research fellow (extended),
Department of Chemistry. MS University, Baroda, INDIA

 Design, development and optimization of synthesis process for tartaric acid based polyamides.
 Characterization and biodegradation study of above polyamides.
 Preparation of hydrogel using various monomers likes acrylamide, N,N’-methylenebisacrylamide, acrylic acid, N-vinyl pyrrolidone, hydroxyethyl methacyrlate (HEMA) etc.
 Studied gel strength, conductivity and release profile of various molecules from the three-dimension polymeric matrix.

11/2000 - 3/2001 Lecturer in Chemistry,
Department of Chemistry. MS University, Baroda, INDIA

 Taught theory and practical at undergraduate students in chemistry.
 Taken practical classes at post graduation student.
 Taken the examination and assess the results both independently and in a team.

7/2000 -11/2000 Lecturer in Chemistry,
Virani Arts and Science college, Rajkot, INDIA

 Taught theory and practical at undergraduate students in industrial chemistry.
 Taken the examination and assess the results both independently and in a team.

ACADEMIC RESEARCH EXPERIENCE :

4/1998 - 7/ 2000:
Worked as a Senior Research Fellow (SRF) in the Council of Scientific & Industrial Research, (CSIR-SRF) New Delhi sponsored project at Department of Chemistry, Faculty of Science, M. S. University of Baroda. Vadodara, INDIA.
Project Title: Preparation and properties of Biodegradable Copolymers

7/1995 - 2/1998:
Worked as a Junior Research Fellow (JRF) in the Dept. of Biotechnology (DBT), New Delhi, sponsored research project at Department of Chemistry, Faculty of Science, M. S. University of Baroda. Vadodara, INDIA.
Project Title: "Preparation, Characterization and Biodegradation Studies of Tailor Made Polymeric Materials".

PATENTS :

1. Harshal P. Bhagwatwar, Mahesh B. Paithankar, Pradeep Sharma, Varada R. Bapat, Ismail A. Mathakiya, Chandrashekhar Kadam, Bhushan Yeola; “Sterile in-situ microcarrier forming gelled polymeric dispersions and processes to manufacture the same”, PCT application No. PCT/IB/2004/000003

2. Bhagwatwar Harshal, Paithankar Mahesh, Sharma Pradeep, Bapat Varada, Mathakiya Ismail, Kadam Chandrashekhar, Yeola Bhushan; " Sterile gelling agents", PCT application No. PCT/IB/03/04509.

SELECTED RESEARCH PUBLICATIONS :
1) "Synthesis and Characterization Studies of Homopolymers of N-Vinyl Pyrrolidone, Vinyl Acetate and Their Copolymers", Ismail Mathakiya, and A.K.Rakshit, J. Appl. Polym. Sci., 68, 91 (1998)*.
2) "Terpolymerization of Acrylamide, Acrylic Acid and Acrylonitrile: Synthesis and Properties", Ismail Mathakiya, Veena Vangani and A.K.Rakshit, J. Appl. Polym. Sci., 69, 217 (1998).
3) "Terpolymers of Acrylamide, Acrylic Acid, Acrylonitrile: Further Characterization and Biodegradation Studies", Bragadish Iyer, Ismail Mathakiya, Avinash K. Shah and A.K.Rakshit, Polymer International, 49, 685 (2000)*.
4) "Synthesis and Characterization of Styrene-Acrylic Esters Copolymers", Ismail Mathakiya, P.V.C.Rao and A.K.Rakshit, J. Appl. Polym. Sci., 79(8), 1513 (2001).
5) "Synthesis and Characterization of Mixed Aromatic-Aliphatic Polyamides", Utkarsh Shukla, Ismail Mathakiya and A.K.Rakshit, Indian Journal of chemistry, 41A, 730 (2002)*.
6) "Novel Biodegradable Polyamides Based on Tartaric Acid", Ismail Mathakiya, P.V.C.Rao and A.K.Rakshit, Int. J. of Polymeric Materials*, 53, 1 (2004).
7) "Preparation, Characterization of Properties of Vinyl Acetate and Acrylic Esters Polymers", Ismail Mathakiya, P.V.C.Rao and A.K.Rakshit – Int. J. of Polymer Analysis and Characterization , 8(5), 339 (2003).

SEMINAR / WORKSHOP /TRAINNING COURCE:
1) "Terpolymerization of Acrylamide, Acrylic Acid and Acrylonitrile: Synthesis and Properties" presented in the 33rd Annual Convention of Chemist at P.S.G.College of Technology, Coimbatoe, 26-31 Dec. 1996.
2) "Synthesis of N-Vinyl Pyrrolidone - Vinyl Acetate Copolymers in Microemulsion Medium : Spectroscopic Characterization of the Polymers" presented in the IUPAC International Symposium on Advances in Polymer Science and Technology at Central Leather Research Institute, Chennai, 5-9 Jan. 1998.
3) "Studies of Thermal Analysis of Homopolymers of Acrylamide, Acrylic Acid Acrylonitrile and Their Terpolymers" presented in the 11th National Symposium and Workshop on Thermal Analysis at Department of Chemistry, University of Jammu, 2-5 March 1998.
4) "Studies of Properties of N-Vinyl Pyrrolidone - Vinyl Acetate Copolymers and Their Hydrolysed Products" presented in the International Symposium on Polymers Beyond AD 2000 at Indian Institute of Technology, Delhi, 12-15 Jan. 1999.
5) "Synthesis and Characterization of Tartaric Acid Based Polyamides" presented in the 36rd Annual Convention of Chemist at Jadavpur University, Culcatta. 11-16 Dec. 1999.
6) "Participates in the one-day workshop on "Application of Nuclear Magnetic Resonance Spectroscopy in Research and Industry" held on 29th January, 2000 at M.S.University of Baroda, India.
7) "Characterization of polymers by NMR spectroscopy" presented in the Second All Gujarat Research scholars Meet at Deptt. of Chemistry, M.S.University of Baroda, Vadodara on 25th February, 2001.
8) “Attended a training program on Fire Fighting organized by Gujarat Safety Council, 16-17 Aug. 2001.
9) “Participated in five days training program on Induction and GMP Course organized Human Resources Department of SPIMACO, KSA, 11-15 March 2006.
10) “Completed an intensive short course on cGMP for Pharmaceuticals organized by The Centre for Pharmaceutical Advancement, at SPIMACO, KSA, 11-13 July 2007.

ACCOMPLISHMENT :

1) Received both CSIR-SRF (Council of Scientific & Industrial Research-Senior Research Fellowship) and CSIR-SRF(EXT) awards to carried out research work in polymer chemistry.

2) Received Second Prize for best presentation in Second All Gujarat Research Scholars Meet held at Deptt. of Chemistry, M.S.U., Baroda on 25th February, 2001.

REFERENCES :

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