Daniel Boster Email & Phone Number

Laval, Québec, Ca

Laval, Québec, Ca

With unrivaled expertise in immunology on both sides of the client/CRO relationship, Nexelis is a leading provider of assay development and specialty laboratory testing. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and soluble large molecules.

Design, develop and qualify preclinical and clinical bioanalytical assays supporting IND enabling studies for novel monoclonal antibody (mAb) drug products. Design, develop, qualify and perform sample analysis of ELISA based potency assays supporting Pharmaceutical Operations characteristics data for IND submission.Coordinate the successful transfer of bioanalytical assays to multiple Contract Research Organizations (CROs) and provide guidance in troubleshooting activities. Provide oversight and scientific expertise in the validation of Pharmacokinetic (PK) and Immunogenicity/Anti-Drug Antibody (ADA) assay platforms supporting analysis of GLP and GCP IND enabling studies. Monitor CRO activities, perform technical review of experimental data and perform review and approval of CRO study protocols, assay validation reports and bioanalytical sub-reports to ensure accuracy, completeness, consistency and regulatory compliance.Organize and manage the bioanalytical assay sample processing, analysis activities and data reporting for internal research studies. Author bioanalytical assay methods, development reports, method optimization reports, qualification reports and bioanalytical sample analysis study reports.

Kagoshima, Kagoshima, Jp

Head of Analytical Biology: Ligand Binding Service for SNBL USA. Principal Investigator and Contributing Scientist roles for multiple Test Facility and Test Site preclinical studies. Provide scientific guidance for GLP method development, qualification, validation and execution of assay methods for evaluation of toxicological and biological endpoints in support of preclinical studies. Design and perform TK/PK/ADA in vitro molecular and Biomarker assays (e.g. ELISA, ECL, multiplexed bead-based technologies). Manage and review data to ensure accuracy, completeness, consistency and regulatory compliance. Provide formal presentations to clients and respond to client inquires as needed to assist in study and assay design. Supervise Ligand Binding personnel.

Thousand Oaks, Ca, Us

Designed, developed and validated early research to late stage PK immunoassays within a GLP lab environment utilizing non-GxP and GxP Electronic Laboratory Notebook systemsPerformed research, GLP and GCP sample analysis for multiple projects concurrentlyOrganized and interpreted project data and authored scientific/technical documentsContributed to the completion of specific programs and projects by participating in the planning and coordination of project activities and providing key input within area of expertise

Lawrence Township, Nj, Us

Bioanalytical Sciences Group Leader providing oversight and guidance in the development and validation of Pharmacokinetic and Immunogenicity assay platforms supporting analysis of GxP preclinical IND enabling studies and clinical assays within a BLII environment for novel monoclonal antibodies and other protein candidates. Identify, analyze and diagnose scientific data and effectively resolve issues to formulate and implement a detailed work-plan to achieve assigned project or technology objectives. Organize and delegate tasks to communicate experimental plans and concepts clearly and cohesively, both orally and in written format by authorship of experimental methods, Standard Operating Procedures (SOPs) and other project related documents to support FDA submissions and regulatory GxP compliance. Analyze, summarize and report bioanalytical data for GLP and non-GLP preclinical studies, and GCP clinical studies through Phase III. Provide scientific expertise on bioanalytical sections of clinical study reports, investigator brochures, INDs, BLAs and manuscripts for publication. Represent department/functional unit with responsibility for coordination and communication between project teams and department/functional units to generate and execute plans and timelines related to project goals. To monitor the analytical experiments and subsequent data results for a specific project and to be a liaison between other functional groups with the company.

Coordinate research study patient enrollment and sample collection (E. coli O157:H7).PCR on O157 cells for presence of various genes including Shiga Toxin genes.EIA and ELISA assays for cytokines and viruses (Rotavirus, Adenovirus, and Astrovirus).DNA isolation and enzyme digestion, with radioactive P32 southern blotting.PCR gel extraction and ligation into T-Easy vectors, DNA Cloning (genomic).Create library efficient cells and plasmids for transformations (electroporation).Bacterial mating of E. coli O157:H7 and non-O157 cells using antibiotic resistances.

Bioengineering lab dedicated to the understanding of structure/function relationship of muscle. Assisted with muscle single cell experiment preparation and procedures. Data entry and SDS-PAGE analysis.