Quality Control Scientist, Analytical Chemist, Chemist, Scientist.
Resume:
Joseph Belen
Hackettstown, NJ 07840
***********@*******.***
Mobile: 973-***-****
Employment:
Johnson & Johnson Family of Consumer Products, Skillman, NJ June 2013 – May 2018 Quality Analyst; North America Source Quality: (Contractor)
• Receive and review Certificate of Analysis (COA) reports (t=0 or release and stability) from mul- tiple external manufacturing and stability testing sites of Over the Counter (OTC), formulated medical devices, and formulated cosmetic products to ensure that the results meet the require- ments indicated in the applicable Product Specifications.
• Communicate with the manufacturing sites and laboratory testing sites for any issues observed with the release and the stability reports.
• Write the Marketed Product Stability (MPS) Summary Reports at the completion of the MPS study or at the applicable time point and forward the documents to the J&J MPS Coordinator and Quality Systems & Compliance Manager for review and approval.
• Review the MPS section of the ADPR (Annual Drug Product Review) reports for OTC products from multiple External Manufacturing site for accuracy.
• Review and approve protocols to initiate MPS stability studies for New Product Initiative (NPI).
• Archives all approved MPS Summary Reports in the QA file.
• Support external and internal groups for any MPS request.
• Act as a backup with in the MPS group.
Janssen Pharmaceuticals (J&J), Raritan, NJ January 2012 – June 2013 Scientist – Analytical Large Molecules Method Development (Contract-Lancaster laboratories)
• Responsibilities include performing cGMP testing of biopharmaceutical samples using HPLC, cIEF (capillary Isoelectric Focusing), Particulate matter (subvisible) analysis, residual moisture analysis, and other physical testing.
• Troubleshooting methods and instrumentation problems; developing and executing method vali- dation plans; carrying out method transfers; feasibility studies; and method development.
• Use Symyx software for electronic laboratory notebook documentation. Astellas/OSI Pharmaceuticals, Inc., Cedar Knolls, NJ March 2009 – December 2011 Development Scientist – Analytical Operations
• Perform daily activities in the analytical lab, supporting Pharmaceutical Operations and Chemical Operations activities associated with manufacture of API, clinical, and commercial drug product in compliance with cGMP and regulatory requirements. Update laboratory SOPs/Test Methods/Work In- structions to ensure all procedures in the laboratory are current and up-to-date. Ensure the laboratories are operating according to safety procedures and the established GMP guidelines. Present responsibili- ties include High Performance Liquid Chromatography (RP, AX, & SEC). Determination of Resid- ual Solvent by Gas Chromatography. Determine levels of Heavy Metal Elements by ICP-OES (Induction Coupled Plasma-Optical Emission Spectroscopy), Dissolution, Water Determination by Karl-Fisher Titration, Cation Content by HPIC, DSC (Differential Scanning Calorimetry), TGA (Thermogravi- metric Analysis), and UV-Vis spectrophotometer.
Eyetech Pharmaceuticals/OSI Pharmaceuticals, Inc., Cedar Knolls, NJ July 2002 – March 2009 Senior Scientist – Quality Control
• Responsibilities include Reverse-Phase (RP) High Performance Liquid Chromatography (HPLC), Anion-Exchange (AX) HPLC, Size-Exclusion Chromatography (SEC) HPLC, Water Determina- tion by Karl-Fisher Titration, Cation Content by HPIC, Determination of Residual Solvent by Gas Chro- matography (GC), Plate Binding Specificity (PBA), Endotoxin testing, Determination of the USP Heavy Metal Elements in Drug Substance (DS) by ICP-OES, Dissolution, Osmolality, Viscosity Determina- tion, pH determination, Clarity, and Appearance analysis of the DS and drug product (DP) stabil- ity/release test. Performs release testing for the DS starting materials by RP-HPLC.
• Performed and reviewed method validation, method transfers and analytical reports.
• Assisted and supported the Analytical R&D, QA and other groups for the NDA filing and FDA inspec- tions. A member of the Safety Committee Team.
• Support the Pharmaceutical Science (PS) and Pharmaceutical Operation (PO) group in performing HPLC-assay analysis for post DP requirements and Phases 0 to III oncology products.
• Update laboratory SOPs/Test Methods/Work Instructions to ensure all procedures in the laboratory are current and up-to-date. Ensure the laboratories are operating in accordance to safety procedures and the established GMP guidelines.
• Active member of the Safety committee.
Hoffmann-La Roche, Inc., Nutley, NJ October 1989 – July 2002 Scientist – Quality Management (Biotechnology) (September 1999 – July 2002)
• Responsibilities includes: SDS-PAGE (Coomassie blue and Silver), Isoelectric Focusing (IEF) analy- sis, and HPLC assay (Reverse-Phase and Size-Exclusion) analysis of liquid dosage for marketed product release/stability test.
Senior Laboratory Technician – Quality Management & Analytical R&D (October 1992 – August 1999)
• Performed SDS-PAGE (Coomassie blue and Silver), and IEF for the IND and BLA submission to the FDA and EU. Assist in the method validation testing. Supported the QM marketed product group for all release/stability test.
• Performed automated and manual HPLC dissolution tests and HPLC assay analysis on solid dosage forms to support the 1ND and NDA submission to the FDA.
• Perform physical evaluation of stability samples such as moisture determination, particle size analysis, pH, APHA determination and disintegration.
Laboratory Technician II – Formulation R&D (October 1989 – October 1992)
• Set-up topical formulations for formal and informal physical stability studies according to prescribed protocol. Maintained and monitored on-going stability samples to ensure that samples were available for physical stability evaluation.
• Physical tests performed were appearance, pH measurements, microscopic examinations, droplet size determination, viscosity measurements utilizing cone and coaxial viscometer, moisture determination, and color analysis.
Education:
Bloomfield College, Bloomfield, NJ August 1999
Bachelor of Science – General Biology
Additional Skills:
• Microsoft Windows
• SQL*Lims
• Total*Chrom
• Peak-Pro and Ultima R4W
• Millennium/Empower (Waters Corp) data acquisition
• iCE280 Analyzer (cIEF), from Protein Simple
• EZChrom software for data analysis (cIEF)
• Chrom Perfect for data analysis (cIEF)
• Symyx software (electronic notebook documentation)
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