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Click here or scroll down to respond to this candidateCandidate's Name
Street Address -16 84th Avenue Home: PHONE NUMBER AVAILABLE
Jamaica, NY Street Address EMAIL AVAILABLE Cell: PHONE NUMBER AVAILABLE
SUMMARY
Senior Quality Management Scientist with diverse education, training and experience in building teams, reducing cycle time, prioritizing and organizing work schedules. Manages labs that are in compliance with FDA regulations of cGMP and GLP. Well trained in analytical techniques in solids, semisolids, liquid pharmaceutical products, both in quality and R&D.
Highly educated and broadly experienced in Pharmaceutical and Dietary/Nutraceutical with hands on experienced in Quality and Production to understand and locate the position of deep down problem associate with Production and Quality. I have all the potential to fix these problems and bring back the delivery on time.
PROFESSIONAL EXPERIENCE
SPI Pharma Inc. Lewes DE June-2014-Present
Analytical Chemist
Developed method and Validated method as per USP.
Planned and wrote validation protocol and its report.
Corrected and verified the existing methods
Developed and wrote operational SOP for the instrument.
Updated existing SOPs and changed control.
Piping Rock Health Products Farmingdale NY Oct-2010-Aug-2013
QC/QA Manager
Created policies and wrote protocols and SOPs and in order to set up the QC lab
Oversaw Release raw materials and finished products
Trained chemists in SOPs, Methods and cGMP
Oversaw planning of the stability program and its maintenance
Corrected and reviewed production formula as per dosage
Developed assay method in HPLC,UV, IR, ICPMS for dietary active ingredients.
Developed specification sheet of Raw materials release and finished Products.
Developed a proven method to retained samples more than 3years for both raw material and finished products.
Pharbest Pharmaceutical Inc. Farmingdale NY March, 2008-Oct-2010
Manager (QC/R&D)
Maintained daily operation of QC laboratory
Carried out stability program and scheduled testing on time.
Managed the flow of samples through the lab according to priorities.
Maintained laboratory supplies and inventories.
Assured all testing is carried out under the FDA guidelines
Lead validation group with method development and method validation works.
Opened investigation report and point out the root cause of an error and suggested
corrective action plan.
Enforced department policies and guidelines in the company
Maintaining cGMP regulation for drug and drug product from start to finish.
Keeping all cGMP regulations under compliance by biweekly audit and corrective program
Managed environmental inspection for the company and follow-up the corrective action previously FDA inspection
Wrote SOP and managed calibration of all instruments on due time.
Interacted with FDA and answered all the audits taken place in quality.
Explained OOS report to FDA.
Interpharm Inc. 75 Adams Ave Hauppauge, NY Oct.2006-Feb 2008
Scientist Research & Development (supervisor)
Pre-formulation study of new product development
Ordered chemicals and laboratory supplies from different vendors and arranged in stock room.
Study brand product side by with our formulation including binary study using HPLC & UPLC.
Study discriminating method to evaluate our product before file for bio-equivalency study.
Distributing works to analysts and checked their work.
Build Excel sheet to compare different results and show in power point.
Developed method in UPLC and transferred HPLC method to UPLC.
Studied dissolution of new products in fed and fasted condition and analyzed using HPLC/UPLC and UV.
Manage FDA inspection for instrument validation and log book.
Roche Pharmaceutical Company Nutley, NJ Jun,2003- July,2006
Senior Quality Management Scientist
Analyzed Assay,UDU, Impurities and Dissolution of finished products using Water's HPLC.
Calibrated Dissolution Equipment.
Audited Laboratories that ensure regulatory compliance standard were met.
Wrote standard operating procedures for UV and Balance instruments.
Expert at troubleshooting instruments during analysis of drug products.
Investigated OOS results and documented laboratory analytical errors in Track wise to determine root cause.
Trained analyst in new methods and method transfers.
Putting data through LIMS and checking LIMS report for releasing drug product.
BMS Pharmaceutical Garden City, NY Feb,1998- Jun, 2003
Quality Control Scientist
Analyzed raw material from USP/NF compendium using HPLC, UV Karl Fischer and Malvern
Tested Assay, related substances and determined purity of API using HPLC and GC and DSC method.
Analyzed packaging product such as bottle and caps using DSC and TGA.
Worked in Inter Laboratory qualification for new methods in HPLC and GC.
Supported R&D for method validation of API using HPLC and GC method.
Worked closely with the Environmental Health and Safety group to ensure safety compliance of the plant.
Putting data through LIMS and checking LIMS report to release drug
Manage FDA inspection on wet chemistry laboratory.
Del Laboratories Farmingdale, NY Aug1997- Feb1998
R&D Chemist
Managed new formulation products for stability study programs .
Tested and reported stability results and its discrepancies at the end of the each stability
time point.
Validated method for Benzocain, alcohol and Fluoride in tooth paste using HPLC, GC and coulometric methods.
Corwood Laboratories Inc. Hauppauge NY Jan.1994- Aug 1997
Quality Control Chemist/supervisor
Responsible for daily laboratory activities of quality control group.
Performed routine tests on raw materials, bulk / finished products and stability pharmaceutical products HPLC,GC, Coulometric/KarlFischer and Refractive index methods.
Analyzed drug product in process validation and method validation HPLC and UV.
Managed and maintained long term and accelerated stability program for cream, ointment, liquid and suspension products.
Analyzed production tank wash for cleaning validation by HPLC and UV method.
Maintained and managed the documents of analysis and provided to FDA and other inspections when needed.
Maintained laboratory supplies and ordered chemicals and column for laboratory usages.
Dow Chemical Company, Midland, MI 1992-1993
Research Fellow - Department of Designed Thermoplastics Research & Consumer Products Research
Synthesized organic molecules and its polymers in pilot plant and its purification and characterization using IR, NMR, MS. Used DSC and TGA for thermal stability and determined molecular weight using GPC.
Made film out of polymer and measured diffusion of different kinds of flavor /aroma solvent molecules through the polymer films using GC/MS.
Synthesized model molecule to study degradation in Saran Wrap.
EDUCATION
MS Chemistry and Polymer science 1989-1993
Central Michigan University Mount Pleasant MI
Thesis: Synthesis and Characterization of Platinated Copolymers of
N-Vinyl-2Pyrrolidone Modified Styrene Monomers as Potential Time -Release Antitumour agents.
MS Chemistry 1986-1988
Depaul University, Chicago, IL
M.Sc Applied Chemistry 1980-1985
Dhaka University, Dhaka, Bangladesh
Thesis: Recovery of nickel from spent nickel catalyst used in the hydrogenation of vegetable oil.
CERTIFICATIONS
Gianco certified for OSHA 40 hour Hazwoper
NJPQCA certified for pharmaceutical quality assurance.
Green belt training certification
Presented a project of rationalization of micropipette in order to reduce cost and error.
SKILLS
Interpretation of IR, NMR, MS, DSC/TGA scans, HPLC, GC,UV, KF, particle
size/Malvern, surface area/Micromeritics, extraction, separation, purification, wet
chemistry analysis. and TLC.
Computer Skill LIMS, Track Wise, Atlas, PowerPoint, Excel
AWARD
Outstanding Thesis and Dissertation Award for 1994
Central Michigan University, Mt. Pleasant, Michigan.
PRESENTATION
Synthesis of an N-Vinyl-2-Pyrrolidone/ModifiedStyrene Copolymer.
ACS meeting at Delta College in Michigan . Nov/1992
Synthesis of 3,4 Dihydroxy Styrene from Catechol Reagent.
ACS meeting at Saginaw State University in Michigan. March/1990
Synthesis of Poly benzoxazoles polyoxadiazole containing preformed imide group
Depaul University, Chemistry Department Symposium. Sept/1987
PUBLICATION
B. A. Howell, B. B. S. Sastry, S. I. Ahmed, P. B. Smith
"Thermal Degradation Characterization of Vinylidene Chloride
2-(3, 4(1, 1-dioxycyclopentyl) Phenyl) Ethyl Acrylate Copolymers" Thermochimica Acta 272 (1996) pp139-146.
B. A. Howell, B. S. Warner, C.V. Rajaram, S. I. Ahmed "Stabilization of Vinylidene
Chloride Barrier Resins". Polymers for Advanced Technologies. Vol. 5, 485
Sharf U. Ahmed, S.I. Ahmed, Poly benzoxazoles polyoxadiazole containing preformed
imide group. Division of Polymeric Material Science and Engineering 59, 949 1988 |
