Dean Bauer work email
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Dean Bauer personal email
BIOANALYTICAL CHEMIST with extensive GMP experience in Quality Control laboratories performing protein and antibody product release and stability testing (CGE, cIEF, HPLC) in support of late stage clinical trials. Project lead for global analytical technology transfer and laboratory deviations. Known for engineering permanent improvements to problematic assays and identifying opportunities to increase laboratory efficiency as an individual contributor and as project lead on multidisciplinary teams. Mentor for junior professionals.Specialties: • Methods Development and Validation• Methods Transfer• Data Analysis / Interpretation• Protocol / Report Writing• Deviation Management / Investigations• Lab Supervision• Analytical Separations - aqueous and non-aqueous HPLC and SEC-MALS, CGE, GC, SFC, SFE, UV, FL, ED, RI, ELSD, Viscometry, Laboratory on a Chip• Immunochemistry (SEC-Rate Nephelometry)• Polymer Characterization
Teva Biopharmaceuticals Usa
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Biological Researcher LllTeva Biopharmaceuticals Usa Jul 2015 - PresentGlobal method validation and transfer for biologics.Full GMP QC release and stability testing for proteins and antibodies by CGE, cIEF, SEC, HPLC and Lab on a Chip
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ScientistLancaster Laboratories Jul 2013 - Jul 2015Lancaster, Pa, UsAssignment at Janssen Pharmaceuticals, Malvern, PA. Method development and validation for therapeutic proteins and antibodies by capillary electrophoresis (CE) to drive improvements in assay precision with results targeted for improvements in manufacturing process variability and control. Adapt and qualify new generation CE equipment for challenging isoform characterization method to support QC and investigational testing. Use experimental design to demonstrate improvements in method precision for cSDS CE. Antibody conjugation and characterization. -
Principal ScientistLancaster Laboratories Feb 2012 - Jun 2013Lancaster, Pa, UsAssignment at Merck, West Point, PA. Finalization of worldwide regulatory submissions for improvements to analytical testing of in-line vaccine product, worldwide assay transfers of new analytical assay, and assay validation of stability indicating assay. -
Sr. Project ScientistMerck 2007 - 2011Rahway, New Jersey, UsProvided Technical Support leadership for Bacterial / Viral Vaccines, APIs and Intermediates Release and Stability Testing in Bio-Separations, Immunochemistry, and Proteins Testing Laboratories. Served as SME on multidisciplinary teams targeting increased business efficiencies and as liaison to Regulatory Affairs. Investigated assay failures, OOS and out-of-trend results, and laboratory atypical events. Designed experiments to prove root cause. Implemented sustainable and permanent corrective actions. Authored investigation protocols and reports. Managed assay development and validation. Conducted Change Control for new assay implementation. Supported regulatory inspections. -
Sr. Project ScientistMerck 2006 - 2006Rahway, New Jersey, UsSupported worldwide product registration and regulatory inspections. Led assay re-development activities for PNEUMOVAX®23. -
Sr. Project ScientistMerck 2002 - 2005Rahway, New Jersey, UsServed as technical support lead for BioSeparations QC Laboratory performing Bacterial and Viral vaccine release and stability testing for active biomolecules, process intermediates, and raw materials. Supported regulatory inspections. Led investigations. Recovered >$1M in products scheduled for discard. Audited raw material vendor. Qualified contract laboratory to perform amino acid analysis. Improved reliability of light scattering (LS) technology in QC laboratory. -
Project ScientistMerck 2000 - 2002Rahway, New Jersey, UsTroubleshot / optimized SEC and HPLC assays for polysaccharide, protein, and small molecules to improve assay robustness and testing efficiencies. Participated in test investigations for product Out-of-Specification (OOS), Out-of-Process Capability, and results trending. Qualified assay reagents and standards. Mentored Summer Intern. Presented SEC-MALS theory and applications to Quality Organization. -
Senior Research ScientistBetzdearborn Division Of Hercules 1981 - 1999Supervised HPLC and SEC method development supporting R&D, Scale-up, and Customer Applications of anti-corrosion agents, biocides, and water soluble polymers for specialty water treatment from assay levels in product to trace levels in industrial process systems and research applications. Reported results to R&D, engineering and field personnel. Developed and implemented liquid chromatography laboratory including Size Exclusion Chromatography with Multi-Angle Light Scattering Detection for polymer molecular weight and size characterization. Transferred assays to satellite laboratories worldwide.
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Chemist IiWyeth Laboratories Jun 1979 - May 1981
Dean Bauer Skills
Dean Bauer Education Details
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Villanova UniversityChemistry -
Ursinus CollegeChemistry
Frequently Asked Questions about Dean Bauer
What company does Dean Bauer work for?
Dean Bauer works for Teva Biopharmaceuticals Usa
What is Dean Bauer's role at the current company?
Dean Bauer's current role is Over 19 years of improving the human condition. Currently as Biological Researcher at Teva Biopharmaceuticals USA.
What is Dean Bauer's email address?
Dean Bauer's email address is db****@****ast.net
What schools did Dean Bauer attend?
Dean Bauer attended Villanova University, Ursinus College.
What skills is Dean Bauer known for?
Dean Bauer has skills like Analytical Methods Development, Protocol And Report Writing, Hplc, Size Exclusion Chromatography, Capillary Electrophoresis, Ir Spectroscopy, Thermal Analysis, Static Light Scattering, Laboratory Supervision, Rate Nephelometry, Size Exclusion, Ir.
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