Research Scientist Resume
Little Falls, NJ
SKILLS SUMMARY
Solid analytical experience in R&D and Quality Control.Presented many talks and solved analytical problems. Work independently as well as in a team environment.Excellent project management skills.Implemented GMP/GLP/ICH regulations .Dependable and have good verbal and written communication. Ability to train Junior Chemists.
PROFESSIONAL EXPERIENCE
Aug.2008 - Apr.2009 Confidential, Brigewater, NJ
Toxicology support for new drug development as per GLP. Chemical analysis of drug safety and stability studies and animal dosing samples. Method development and validation
and documenting for new toxicology studies.
May.2006 - Apr.2008 Confidential, Brigewater, NJ
Research Scientist, Analytical Sciences
Method development , validation and stability testing of new pharmaceutical products as per GMP
Jan.2004- Mar.2006 Confidential, New Providence, NJ
Research Scientist, Analytical Sciences Method development , validation and stability testing of new pharmaceutical products as per GMP
Jan. 2001 Jan. 2003 Confidential
Senior Scientist A, R&D Mission Critical Team
Stability studies on marketed products and transfer analytical methods from Block Drug Co. to Glaxo Smithkline faclities.
Dec. 1976 Dec. 2000 , Confidential
Senior Scientist A, R&D Analytical Research
Develop, validate and transfer of analytical methods. Worked on problems of diverse scope where analysis of data requires in-depth evalution with minimal supervision.
ACCOMPLISHMENTS
Develop, validate and transfer analytical methods for new finished products, modify and optimize existing methods from impurity level to major components, and residual methods applied to cleaning validation. Responsible for analyzing special non-routine research projects. Isolation, identification and quantification of competitive products to help new product development.Impurity profile and stability studies on marked products, new formulation, OOS investigation and document preparations. Experience of ANDA and NDA products.Responsible for coordinating with process development group to qualify raw material supplier and update specification for cost reduction.Perform bio-availability of drugs in-vivo and in-vitro study.Knowledgeable in rheological behavior of gums, polymers and finished products. Calibrate instruments as per SOP's.
INSTRUMENTS & TECHNIQUES
Computerized data handling , GC, HPLC, GPC, IC with variety of detectors, TLC, UV, VISIBLE, IR, AA Fluorophotometric, Ion-Selective electrode and polarographic methods. Organic and inorganic Functional group analysts by wet chemistry. Distek and Vanderkamp dissolution apparatus, Zymark Benchmate II and Horiba LA 910 Laser Scattering Particle Size Analyzer. Familiar with Microsoft Word, Excel and Access. Knowledgeable of major drug compendia (USP / NF /EP /BP/ JP )
EDUCATION
Regular participation in attending Courses, Seminars, meetings and training programs such as ACS, EAS, PITTSBURG, ASTM, and FDA.
Many certificates in Analytical field and computers for short courses.
PUBLICATIONS
- Simultaneous determination of Nitrate and Nitrite in Toothpastes by High-Performance Liquid Chromatography. H. Lulla, S. S. Chen and F. J. Sena; Jr. Pharma Sci; Vol. 73, No 7, July 1984
- Simultaneous Determination of Potassium Nitrate and Sodium Momofluorophosphate in Dentrifices by single column Ion Chromatography. S. S. Chen, H. Lula, F. J. Sena; Jr. Chrom. Sci; Vol. 23, August 1985
- Simultaneous Determination of antitussive, Antihistamine, Decongestant and Analgesic Drugs by Reversed Phase High Performance Liquid Chromatography. H. Lulla, Z. Zaide and S. Chen, Poster Presentation, P.A. Meeting, NYC, Dec
In 2000 for solving complex problem which saved approximately $4MM to company as well as averting a recall situation.
In 1980 for analyzing Fixodent a competitive denture adhesive product.
Overtime Team awards for finishing back log.
REFERENCES
Furnished upon request.
