o Develop and validate methods for experimental drug candidateso Perform characterization studies for impurities, degradants, intermediates, and active components of drug substances and drug productso Write and review method transfer protocols and method SOP’so Perform analytical testing to support process development and release/stability testingBackground qualifications include the following:o Technical experience must include analysis of proteins by HPLC (SEC, RP-HPLC, IEX), electrophoretic techniques (SDS-PAGE, IEF, Western blotting), and spectroscopy (UV and VIS)o Additional technical experience in the following areas is preferred: biophysical techniques (CD, FTIR, DSC); mass spectrometry (electrospray, MALDI); capillary electrophoresis; peptide mapping; amino acid analysis; protein sequencingo Working knowledge of important aspects of analytical development in the pharmaceutical industry, particularly pertaining to cGMP and method validation requirements

January 2014 – Present Monmouth Junction, New Jersey • Performed and documented the necessary in house physical and chemical testing on all in-process and sterilized product to comply with release requirements, stability and product development.Assist in developing writing or revising test methodsAssist in data collection and trend analysis in on-going monitoring and test results• Cost owner: Maintaining budget and inventory for company supply and providing solutions for effective cost keeping within the company• Training co-workers on various methods and scientific techniques• Safety officer: Ensuring safe practice within the company and per regulations• Performed analysis and report of intermediate raw materials & finished product• Analyzed stability samples• Managed and administered Sampling, Testing and Report of various raw materials• Dispensed various raw materials for batch preparation• Reviewed documents for Quality Assurance at in process stage & before the batch release• Analyzed visual inspection of injectable• Prepared and standardized Volumetric Solutions, Reagents• Operated various technical laboratory instruments such as:• pH Meter• Conductivity Meter• Hardness tester• UV Spectrophotometer, HPLC• Karl Fischer Auto Titrator• Disintegration Tester• Friability Tester• Dissolution Tester

• Position: Scientist• Review analytical work and documentation of chemists.• Developed and validated HPTLC methods for API dosages.• Group leader in maintaining and ordering supplies and equipment for the laboratory, purchasing chemicals and equipment for daily maintenance and laboratory use.• Assisted metrology with instrumentation calibration and dealing directly with vendors with purchasing.• Preparing purchase orders for ordering instrumentation and necessary equipment for the laboratory needs.• Coordinating and arranging annual maintenance for laboratory equipment and as per need basis• Advise Scientists on technical aspects of projects.• Responsible for the GMP analytical development activities and evaluation of various dosage forms such as tablets, liquids, suspensions, topical, powders and implant formulations from proof of concept to commercial launch.• Developed analytical techniques such as Assay, Dissolution, and Mass spectrometry for the evaluation of drug product/API performance, stability and submission documentation. Utilize these techniques to establish acceptable specifications for drug product and drug substance.• Scientific technical reviewer/ approver for methods, specifications, reports, regulatory submissions, protocols and any other document requiring scientific review.• Successfully coordinate, author and execute cGXP and experimental protocols; such as method validation, method transfer, technology process transfer, stability studies and regulatory responses.• Mentored and trained other associates in proper procedures (SOPs), analytical techniques and Good Manufacturing Practices (GMP).• Discovered novel ideas for future products as well as to reduce costs and decrease the time associated with research and developmental functions.

• Performed GMP release and stability testing for investigational drug products (e.g., density testing for injectable solution products).• Maintained the VEI room supplies.• Maintained strict adherence to cGMPs and SOPs.• Performed wet chemistry testing on samples provided.• Performed in-process testing for a 24 hour plant situated in Union, New Jersey.