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      • HPLC Method Development Validation
      • Mass Spectrometric Analysis
    • ELISA Method
      • Meso Scale Discovery Assay
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                • Method Development
                • Method Transfer

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                                                              • Bioanalytical Chemist

                                                              Bioanalytical Chemist

                                                              Job Description

                                                              • Coordinates projects and work activities with Laboratory Management to meet established objectives
                                                              • Exhibits good interpersonal skills, a professional attitude, and excellent written and oral communication to produce consistently high-quality work
                                                              • Prepare solutions and reagents used in the laboratory and document them in the lab notebook promptly
                                                              • Perform tasks assigned by the senior scientist on sample processing, method validation, method development experiments
                                                              • Maintain calibration records for laboratory equipment and instruments, keep inventory and expiration for materials, chemical reagents, consumables, samples, and solvents
                                                              • Ensure cleanliness, adequate inventory, organization, unambiguous labeling, current calibrations, personal safety, and ensure all reagents for use are not expired or compromised
                                                              • Perform study sample analysis and generates analytical test results in compliance with SOPs/protocols using applicable guidelines: GLP (OECD), EMEA, ICH, FDA, and other GxP requirements
                                                              • Document and communicate any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies)
                                                              • Assist Senior scientists in literature search, plan and carry out complex research projects, such as new method development of new drugs and testing methods
                                                              • Develop and conduct analytical method validation/qualification/ transfer and study sample analysis according to protocol, SOPs, and regulatory guidance (GLP/GCP) and additional regulations as required
                                                              • Perform task assigned by the senior scientist on sample processing and method validation experiments
                                                              • Perform experiments as per Standard Operating Procedure (SOPs) and as required by study protocols
                                                              • Conduct tests on materials and other substances to ensure that safety and quality standards met
                                                              • Revise/review/author test methods and technical reports
                                                              • Generate method procedures, results, validation, re-validation, and analytical reports for direct submission to regulatory authorities (FDA)
                                                              • Support Sponsor audits and reviews compliance with sample management, including central lab services and Environmental Monitoring System-related activities
                                                              • Compile and archive study/validation data
                                                              • Generate method procedures, results, validation, re-validation, and analytical reports for direct submission to regulatory authorities
                                                              • Assist in sample management for long-term storage of biological samples such as plasma, urine, serum, whole blood, CSF, FFPE blocks/ slides of tissue biopsy

                                                              Qualifications / Experience

                                                              • M.S/B.S in biochemistry, analytical chemistry, life sciences, biotechnology, or related areas
                                                              • 3+ years experience in analytical or clinical research setting
                                                              • Familiarity with EDC system is an asset
                                                              • Proven ability to multitask and prioritize
                                                              • Excellent oral and written communication skills
                                                              • Ability to work independently with excellent attention to detail
                                                              • Excellent organization and problem-solving skills
                                                              • Ability to keep detailed and accurate records
                                                              • Proficiency with MS Office, Excel, and Word

                                                              If interested, please e-mail your resume to careers@nebiolab.com.

                                                              Expertise

                                                              • Liquid Chromatography Mass Spectrometry
                                                              • ELISA Method
                                                              • Meso Scale Discovery Assay
                                                              • Luminex Multiplex Assay
                                                              • LI-COR Odyssey Assay
                                                              • PK PD Analysis
                                                              • Method Development Validation and Transfer

                                                              Services

                                                              • Pharmacokinetics (PK) Study
                                                              • Toxicology (Tox) Study
                                                              • ADA Assay Immunogenicity Testing
                                                              • Biomarker Testing Services
                                                              • Bioequivalence and Bioavailability Studies
                                                              • Bioanalytical Assay

                                                              Solutions

                                                              • Bioanalysis
                                                              • GLP Laboratory
                                                              • Clinical CRO
                                                              • Preclinical CRO
                                                              • Analytical Testing
                                                              • Non-GLP Testing

                                                              About Us

                                                              • Overview
                                                              • Why Us?
                                                              • Values
                                                              • Leadership
                                                              • Process
                                                              • Quality and Compliance
                                                              • Facility and Equipment
                                                              • Therapeutic Areas
                                                              • Partners
                                                              • Careers

                                                              Resources

                                                              • Learning Center
                                                              • Blog
                                                              • Case Study
                                                              • News and Events
                                                              • Testimonials
                                                              • Contact Us
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