Biological Researcher Lll
CurrentGlobal 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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Dean Bauer is listed as Biological Researcher lll at Teva Biopharmaceuticals USA, based in Blue Bell, Pennsylvania, United States. AeroLeads shows a work email signal at tevapharm.com and a matched LinkedIn profile for Dean Bauer.
Dean Bauer previously worked as Scientist at Lancaster Laboratories and Principal Scientist at Lancaster Laboratories. Dean Bauer holds Master Of Science, Chemistry from Villanova University.
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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
Listed skills include Analytical Methods Development, Protocol And Report Writing, Hplc, Size Exclusion Chromatography, and 20 others.
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Global 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
Lancaster, Pa, Us
Assignment 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.
Lancaster, Pa, Us
Assignment 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.
Rahway, New Jersey, Us
Provided 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.
Rahway, New Jersey, Us
Supported worldwide product registration and regulatory inspections. Led assay re-development activities for PNEUMOVAX®23.
Rahway, New Jersey, Us
Served 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.
Rahway, New Jersey, Us
Troubleshot / 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.
Supervised 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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Dean Bauer works for Teva Biopharmaceuticals USA.
Dean Bauer is listed as Biological Researcher lll at Teva Biopharmaceuticals USA.
AeroLeads has found 1 work email signal at @tevapharm.com for Dean Bauer at Teva Biopharmaceuticals USA.
Dean Bauer is based in Blue Bell, Pennsylvania, United States while working with Teva Biopharmaceuticals USA.
Dean Bauer has worked for Teva Biopharmaceuticals Usa, Lancaster Laboratories, Merck, Betzdearborn Division Of Hercules, and Wyeth Laboratories.
You can use AeroLeads to view verified contact signals for Dean Bauer at Teva Biopharmaceuticals USA, including work email, phone, and LinkedIn data when available.
Dean Bauer holds Master Of Science, Chemistry from Villanova University.
Dean Bauer is listed with skills including Analytical Methods Development, Protocol And Report Writing, Hplc, Size Exclusion Chromatography, Capillary Electrophoresis, Ir Spectroscopy, Thermal Analysis, and Static Light Scattering.
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