Robert Fu

Scientist (Contract) at Purdue Pharma L.P.
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Contact Information
us****@****om
(386) 825-5501
Location
Raritan, New Jersey, United States, JE

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5.0

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/ Based on 2 ratings
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Andrew Morel

During the time Bob and I worked together at Johnson and Johnson, I found him to be an outstanding analytical scientist. He was well respected by his peers and was a great team player. He had the right attitude to ensure GMP compliance in all areas of his work.

Ronnie McDowell

Robert worked under my supervisor for two of the ten years we worked in the same analytical department. He has always shown himself to be a very good analytical Scientist with capabilities to operate various types of laboratory instrumentation, including automated systems. He is also fundamentally sound in method development and validation as well as pharmaceutical product development. Robert would certainly be a welcomed addition to any analytical laboratory and I highly recommend him.

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Experience

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Scientist (Contract)
      • Feb 2013 - Present

      •Developed, optimized extraction and HPLC methods for API and new formulation products and its impurities. •Performed routine dissolution, degradation assay and assay test for stability products. •Support of new and improved Tamper Resistance Design formulation product. •Tested and release clinical stability study products. •Ensured safe laboratory operations and documentation were compliance to cGMP, GLP, ICH, and FDA requirements. •Developed, optimized extraction and HPLC methods for API and new formulation products and its impurities. •Performed routine dissolution, degradation assay and assay test for stability products. •Support of new and improved Tamper Resistance Design formulation product. •Tested and release clinical stability study products. •Ensured safe laboratory operations and documentation were compliance to cGMP, GLP, ICH, and FDA requirements.

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Contract Chemist II
      • Jul 2010 - Jun 2012

      •Performed methods development, methods validation, methods transfer. •Performed API assay and impurities profiling. •Performed forced degradation study and identify impurities/degradation products. •Design and carry out experiments to solve technical problems related to products and processIssues. •Responsible for conducted analytical technical support for development of consumer products. •Preparation of documentation for support product lunches and regulatory submissions. •Ensured laboratory operations were compliance to cGMP, GLP, ICH, and FDA requirements. Show less

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Scientist
      • Jan 1999 - Jan 2010

      •Developed and optimize HPLC method for drug substance, impurities and products. •Use non- routine approaches to solve challenging technical problems related to product development., •Performed solubility studies for new drug substance and pharmaceutical intermediate. •Analyzed and released cGMP API Drug substance, stability, and clinical samples. •Analyzed Monoclonal antibody for purity aggregates and fragments in the downstream purification process and stability CENTO products released for Centocor. •Wrote/reviewed drug substance, assay, SOP for analytical test methods and specification for cGMP release samples. •Developed, validated, assay and USP 1,2,4 &7 dissolution methods plus methods transfer for a broad range of drug products in various phases of pharmaceutical development. •Managed new analytical project development and execution of deliverables and coordinated with multidisciplinary group at multi-site, which support project transfer between phases (early & late) and NDA regulatory filling documentation requirements. •Developed and validated automated test methods and automates existing manual methods, result in 50% increased in productivity. •Used Fiber Optic system to conducted routine API screening with Mini-Intrinsic dissolution and with different media plus FeSSIF & FaSSIF media, result in shorter method development time. Show less

    • Senior Associate Research Scientist
      • Jan 1992 - Jan 1999

      •Collaborated cross-functionally with operations,marketing and R&D to identify new business opportunities. •Evaluated drug stability and degradation of products by using HPLC, UV and TLC. •Designed and developed analytical methods and validations for new products. •Applied knowledge of tablet coating and manufacturing processes to resolve problems. •Hands-on experience of basic solid, liquid, liquid suspension, effervescent and softgel dosage forms. •Ensured laboratory compliance of cGMP,GLP, ICH, FDA and USP/NF regulations and requirements. •Wrote/reviewed analytical methods and standard operating procedures (SOP) for lab instruments. Show less

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