Development Quality Control
Resume:
SUSHIL ZINZUWADIA
************@*****.***
Bedminster, NJ-07921
Day Time Phone #: 908-***-****(Home) 908-***-****(Cell)
SUMMARY OF EXPERIENCE
SUMMARY
• Twenty years of experience as a researcher, scientist in the pharmaceutical
industry.Combination of excellent technical and communication skills with laboratory
experience. Extensive experience with methods development, validation, reference standards
qualification, pre-clinical to Phase III drug development. Excellent analytical skills and
demonstrated proficiency in leading and mentoring individuals to maximize levels of
productivity, while forming cohesive team environments. Strong communication skills and
an ability to work individually or as part of a team, self motivated and quick learner on new
technologies that improve the business.
Expertise:
Highly familiar with USP,EP, FDA, ICH guidelines
GC, HPLC, UPLC and Dissolution Methods Development and Validation as per ICH
guidelines
Working expertise with GC, UPLC, HPLC, Dissolution, FT-IR/ATR, UV/VIS, TLC,
Karl-Fischer and Sotax automated dissolution system
Familiar with Wet chemical analysis, Raw material analysis using LC-MS, Particle
size analysis and Water TOC analysis.
Analysis of APIs, liquid, solid and suspension dosage forms and aerosol products
Preparation of regulatory documents
Reference standards qualification
Laboratory investigations (OOS/OOT Investigation.)
Expertise in problem solving and troubleshooting in analytical methods and instruments
Analytical method transfers
Excipients compatibility
Working under cGMPs and GLPs
Process and cleaning validation
Drug substance and drug product stability and Release
Drug product development/formulation support
Expertise in Millennium, Empower and TotalChrom, Chromeleon and Sample
management (Labware)
Working knowledge of Track-wise, Document management system (DOMASYS),
Web based training (Le@rn), CQ LIMS, database, SALSA, NASCA, and familiar
with environmental system (Amega view)
Professional Experience
Merial LTD (SANOFI Company), North Brunswick NJ, Apr 2011 – Jan2012
Chemist (Temp), Analytical Department
Working knowledge of LC-MS using Xcaliber software.
Working knowledge of NMR using TopSpin software.
Participate in analytical method development/validation for active pharmaceutical
ingredients and finished products.
Prepared validation protocol, report and method for stability indicating method and
dissolution
Performed instrument troubleshooting and method problem solving when necessary
Responsible for Stability and release testing of developmental products.
Understands and complies with Safety, Good Laboratory Practices (GLPs), GMPs,
Standard Operating Procedures and Policies.
Records, evaluates, interpretsand summarizes technical data.
Developed and validated calculation procedures.
Document the all activities in technical notebooks or validated approved electronic
media. Prepares reports, memos or regulatory documents.
Performed second chemist check function.
Novartis, East Hanover NJ, Jan 2011 – Mar 2011
Scientist II (Temp), Analytical Development
To support formulation development study and stability testing
Maintain lab according to site safety regulations
Maintain a laboratory notebook and ensure data and report quality in compliance with
GLP/GMP requirements
Perform laboratory investigations
Sun Pharmaceuticals, Cranbury NJ, Oct 2010 – Jan 2011
Reviewer and Chemist
Review Analyst notebook and worksheet
To support formulation development study and stability testing
Developed and validate HPLC and Dissolution method.
Catalent Pharma Solutions, Somerville, NJ, March 2010 – September 2010
Scientist II (Temp), Analytical Department,
Work in method development group, Developed and validate HPLC, GC and
Dissolution method.
Evaluate customer’s new methods.
Trained new scientist for GC method
Sanofi-Aventis Pharmaceuticals, Bridgewater, NJ, Sept 1994 – Dec 2009
Scientist II, QA-QC Department July2007 –Dec 2009
Scientist II, Analytical Science Department Sept 1994 – July2007
• Participated in the method development and validation of site-specific methods (stability
indicating assay/impurity HPLC, UPLC, GC, dissolution, content uniformity and
cleaning verification)
• Experience in HPLC analysis (Dissolution, Assay, Content Uniformity, and Blend
Uniformity).
• Performed Dissolution and Drug Release for Finished and Stability products using auto
UV and HPLC methods
• Prepare documents such as analytical procedures, validation protocols and reports,
stability protocols and reports for drug substance and drug product
• Performed wet chemical analysis. Raw material analysis for release and generate COA
• Responsible for stability chambers monitoring by Amegaview
• Participated in writing and reviewing department’s SOPs
• Conduct deviation investigation, OOS/OOT investigation and prepare deviation or
OOS/OOT investigation reports
• Qualification of primary and secondary reference standards for new molecular entities
• Improved work efficiency by making timely decision, solving problems and organizing
workloads according to priority.
• Interacted with the Chemists in analyzing and solving analysis problems. Trained new
chemist
• Responsible for testing of clinical and stability samples under FDA guidelines and GMP
regulations clinical samples analysis.
• Transferred analytical technology from Development to Quality Control labs
• Set up new labs, coordinate the activities with external contractors to maintain / calibrate
the analytical equipment to appropriate level
• Supported formulation development of Inhalation and Nasal products including
Azmacort® and Nasacort AQ®. Established and validated test methods for release and
stability
• Train new chemist for aerosol testing
• Supported formulation development from Phase I through Phase III.
• Performed laboratory investigations
• Provided CMC documentation for IND filings
• Presented data in project team meetings
R.W. Johnson Pharmaceutical Research Institute, Spring house, Jan 1993 – July1994
Research Assistant (temp)
• Responsible for analytical testing of manufactured intermediates finished products,
stability samples and experimental samples
EDUCATION:
M.S.Organic Chemistry - Natural/Synthetic Drugs: R.A. Science College, Ahmedabad, India
M.S. Analytical Chemistry : University School of Science, Ahmedabad, India
B.S. Chemistry: M.G. Science Institute, Ahmedabad, India
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