Experience

Prolong Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Scientist

  • Sep 2015 - Present

  o Develop and validate methods for experimental drug candidates o Perform characterization studies for impurities, degradants, intermediates, and active components of drug substances and drug products o Write and review method transfer protocols and method SOP’s o Perform analytical testing to support process development and release/stability testing Background 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 sequencing o Working knowledge of important aspects of analytical development in the pharmaceutical industry, particularly pertaining to cGMP and method validation requirements Show less



Medtronics Inc.

• United States
• Medical Device
• 1 - 100 Employee

• Chemist

  • Oct 2014 - Sep 2015

  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 methods Assist 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 Show less



Merck & Co

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Scientist

  • Jun 2004 - Nov 2013

  • 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. Show less



Schering-Plough Research Institute

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Analytical Chemist

  • Sep 2003 - Jun 2004

  • 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. • 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.