Quality/Project Manager
Resume:
SHILPA PATEL
(H) 908-***-**** (C) 908-***-****
Email: *********@*****.***
Well-regarded chemist with pharmaceutical experience whose accomplishments reflect excellent laboratory skills, a keen attention to details, and a demonstrated commitment to getting the job done right
SUMMARY OF QUALIFICATIONS
• Meticulous analytical chemist with five years of experience in the testing of pharmaceutical products and demonstrated expertise in HPLC, TLC, UV, IR,KF, Dissolution, Water activity, Disintegration, and wet chemical techniques.
• Familiar with the WATERS HPLC, Hitachi HPLC, Agilent HPLC equipments.
• Excellent knowledge of quality control principles and good manufacturing practices.
• Strong problem-solving skills. Systematic in approach. Thorough in follow-through.
• Organized, accurate, and efficient. Valued for discipline, dedication, and willingness to go the extra mile to achieve goals.
• Flexible and accommodating. Comfortable working both independently and as part of a team.
• Excellent computer skills. A fast learner with a large capacity for growth. Capably conducted testing, ensuring compliance with all appropriate industry standards (cGMP, FDA, GLP, SOP, USP, and NF).
• Performing Out of Specification investigation and documenting result
PROFESSIONAL EXPERIENCE
Bristol-Myers Squibb Company, New Brunswick, NJ Aug.2010/Present
Pharmaceutical Development Technician, Analytical R & D;
• Supported HPLC method validation for determination of API Purity and Impurity.
• Performed analytical testing of different active ingredients and drug finish products by using HPLC.
• Performed the Dissolution test.
• Performed drug product stability study.
• Operate and maintain all laboratory equipment to ensure adherence to “Good Laboratory Practices” (GLPs), Standard Operating Procedures (SOPs), and protocol guidelines.
• Familiar with Empower (Waters) data acquisition systems with analytical instruments HPLC.
• Maintain ELN notebook (Symyx) calculates results and reports the results to supervisor and entry the data in PDLIMS.
• Knowledge of GLPs, and GMPs regulations.
Merck & Co. Inc., Rahway, NJ April 2009/April 2010
Chemist
• Worked in the Atomic Spectrometry Group.
• Skilled in working with ICP-Atomic Emission Spectroscopy, ICP-Mass Spectrometry.
• Supported about 55 projects across Merck (research materials).
• The Lead in supporting Outsourcing Projects to a third party company.
• Kept an accurate Outsourcing record through Microsoft Excel.
• Maintained and kept lab operations, qualifications and maintenance of analytical instrumentation in good working condition as regulated by Merck's Safety dept.
Colgate Palmolive, Piscatway, NJ June2008/Dec.2008
Scientist
• Analyzed raw materials, in-process samples, Finished product and stability samples on oral care products.
• Established strong record in analyzing oral care samples by in-house test methods using Atomic Absorption Spectroscopy and HPLC.
• Followed all General laboratory Procedures.
• Analyzed, reported and documented analytical data according to C-P procedures with cGMP practices.
• Maintain and kept Lab operation, qualification and maintenance of analytical instrumentation according to C-P procedures.
• Familiar with out of specification (OOS) results investigations.
Sanofi-Aventis, Bridgewater, NJ Aug.2007/April 2008
Analytical Chemist
Analyzed raw materials, Stability samples on the pharmaceutical products.
• Established strong record in analyzing pharmaceutical samples by USP, NF, EP, JP and in-house test methods using HPLC, TLC,UV, IR, Karl fisher and wet chemical techniques.
• Proactively troubleshoot problems, taking systematic approach to identifying and addressing anomalies.
• Consistently followed current good manufacturing guidelines in testing process-related samples.
• Working knowledge of large molecules such Oligonucleotides. Worked on analytical methods for large molecules. Supported Stability and API releases.
• Used software for HPLC waters Millennium.
• Experienced in Track wise and LIMS.
• Initiated and supported the primary stability testing of drug substance and drug product batches for Phase III project.
Celsis Lab., Edison, NJ FEB./2006 to Aug.2007
Analytical Chemist
Analyzed raw materials and finished pharmaceutical products in high-volume contract lab environment.
• Analyzed pharmaceutical samples by USP, NF, EP, FCC, JP and in-house test methods using HPLC, TLC, UV, IR, Karl fisher, Dissolution and wet chemical techniques.
• Consistently completed required testing within stringent contractual time constraints, gaining respect of clients while building reputation for efficiency and commitment to service.
• Maintained cGMP compliance, calibrated and maintained laboratory equipment.
• Used software for HPLC waters Millennium & Agilent 1100 Series Chemstation.
ITPL INC., Paterson, NJ OCT./2002 toFEB./2006
Analytical Chemist
Analyzed raw materials, Stability samples, in-process samples and finished pharmaceutical products in high-volume contract lab environment.
• Established strong record in analyzing pharmaceutical samples by USP, NF, and in-house test methods using HPLC, TLC, UV, IR, KF, Dissolution and wet chemical techniques.
• Competently performed dissolution testing of solid dosage forms, physical and chemical testing of raw materials and finished products.
• Analyzed Content uniformity, Dissolution profiles, Assay, Impurity tests by HPLC.
• Capably handled all testing-related processes including preparation of standards, calibration of instruments and equipment, review of analytical data, and preparation of investigation reports.
• Developed and documented standard operating procedures for lab use.
• Proactively troubleshoot problems, taking systematic approach to identifying and addressing anomalies.
• Satisfactorily completed all cGMP and safety training in conformance with departmental requirements.
• Carried out Peer review of the analytical raw data and reports for accuracy and compliance
• Trained Associate Scientists on instrumentation such as HPLC, IR, and UV-Vis etc.
• Actively participated in customer audits and internal QA audits.
• Effectively communicated with other departments such as QA, QC to ensure all the scheduled activities were completed in a timely manner.
SCIENTECH LABORATORIES, INC., Somerville, NJ DEC./2000 to OCT./2002
Chemist
Performed analysis of pharmaceutical products in contract lab environment. Conducted dissolution testing of solid dosage forms. Calibrated and maintained equipment.
• Analyzed of finished products by USP, NF, and in-house test methods using HPLC, AA, UV, IR and wet chemical techniques.
ATUL PRODUCTS, Gujarat, India AUG./1992 to FEB./1994
Chemist
Provided analytical support to the R&D group for this leading chemical manufacturer. Tested raw materials using UV, IR, and wet chemical techniques. Maintained laboratory equipment. Prepared test reports.
• Established quality of raw materials through chemical testing to support efforts of internal groups.
• Assisted in developing product and process specifications.
EDUCATION
GUJARAT UNIVERSITY, India
Bachelor of Science Degree in Chemistry.
Professional Development
Medical Technology Certificate, M.P. Shah Cancer Hospital, India.
Analytical Testing Certificate, Chromak Research, Inc., Somerset, NJ.
Computer Information Systems, Compulearn Institute, Edison, NJ.
COMPUTER SKILLS
Word , Excel , Access , Email , Internet
Oracle , VB , C , C++ , UNIX , HTML Programming
REFERENCES
U.S. Citizen
References gladly provided upon request
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