David

About David

Developed a life-long career in drug product process development of protein biologics…

Experience

1. Principal Scientist

   Amgen

   Oct 2003 — Present · Thousand Oaks, CA, US

   Clinical and Commercial Tech Transfer Lead; Developed and employed bench scale filling equipment and methodologies to establish offline capabilities for tech transfers into clinical and commercial manufacturing sites Supported the commissioning (FAT, SAT, CQV, characterization and validation) of manufacturing scale filling equipment Automation and High Through-Put Technologies Implementation; Proven leader in establishing an automated high through-put analytical laboratory (automated visible and sub-visible inspection, analytical & compendial test (A280, pH) assays, high-speed printing and labeling of primary containers, automated UF/DF) from the ground-up Effective managing of commercial vendors, hardware & software engineers, and data scientist to create and implement automated analytical instrumentation Successfully lead the formulation development for two marketed commercial products (Repatha® and EVENITY®) Developed and executed assays to assess mAbs and other biotherapeutic physical, chemical, thermal and colloidal stability and manufacturability using multiple analytical techniques Expertise in biophysical characterization of liquid biologic proteins to assess critical quality attributes; Deep understanding of protein aggregation, stability and manufacturability Separation: HPLC (RP, SEC, IEX), and method qualifications/validations Protein: SDS-PAGE vertical and flatbed (IEF, Coomassie, silver staining, western), enzymatic assay, quantitative assay, In-gel digestion, Protein/antibody purification: FPLC, sepharose-bead coupling, affinity purification (protein A/G), Immuno-precipitation (IP), cell factory, Mass spectrometry (LC/MS for Lys-C/Glu-C peptide maps), Capillary electrophoresis; Experience with 7 years of cell culture (mammalian, bacterial, hybridoma), flow cytometry; DNA: Transformation, transient and stable transfection, viral infection, subcloning (restriction digests, PCR), In Vivo Mouse Bioassay

Skills

• Protein Chemistry
• Polymerase Chain Reaction (Pcr)
• Glp
• Drug Development
• Biopharmaceuticals
• Sds-Page
• Immunoassays
• Cell Culture
• Antibodies
• Molecular Biology
• Validation
• Pcr
• Laboratory Information Management System (Lims)
• Elisa
• Ind
• Biotechnology
• Protein Purification
• In Vitro
• Purification
• Art
• Lims
• Good Laboratory Practice (Glp)
• Clinical Development
• Chromatography
• Drug Discovery
• Technology Transfer
• Assay Development