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Expertise

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

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              • All Services
                • Pharmacokinetics (PK) Study
                  • Drug Metabolism and Pharmacokinetics (DMPK)
                  • ADME Studies
                • Toxicology (Tox) Study
                  • Dose Formulation Analysis
                • ADA Assay Immunogenicity Testing
                  • Biomarker Testing Services
                    • Biomarker Assay List
                  • Bioequivalence and Bioavailability Studies
                    • Bioanalytical Assay
                      • Biochemical Assay
                      • Mechanism of Action (MOA) Studies
                      • Cell-based Assays
                      • Cytotoxicity Assay

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                              • Cosmetic Testing

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                                                  • GLP Quality Assurance Manager, Bioanalytical Lab
                                                  • Sr. Scientist, ELISA Immunoassay Bioanalysis
                                                  • Sr. Scientist, LC-MS/MS Bioanalysis – Hamden, CT, USA
                                                  • Associate Scientist, Central Laboratory Services
                                                  • Sr. Scientist - Pharmacokinetics (PK) Studies
                                                  • Content Manager, Scientific and Regulatory Writing

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                                                              • GLP Quality Assurance Manager, Bioanalytical Lab

                                                              GLP Quality Assurance Manager, Bioanalytical Lab – Hamden, CT, USA

                                                              NOTE: PLEASE SUBMIT BOTH RESUME AND COVER LETTER TO APPLY FOR THIS JOB. KINDLY DISCUSS YOUR MOTIVATION, RELEVANT EXPERIENCE, SALARY REQUIREMENTS, AND VISA STATUS IN YOUR SUBMISSION.

                                                              Role

                                                              • Ensure high-quality, compliant GLP and non-GLP data for LC-MS/MS and HPLC-UV OR ELISA, MSD, Luminex, and qPCR, bioanalysis projects
                                                              • Host Regulators, Sponsors, Potential Clients, and Lead Audit/Inspection Response Team
                                                              • Review all study documentation covering method development, validation, and sample analysis for drug and biomarker bioanalysis of customized Chromatographic and Ligand Binding Assay
                                                              • Perform/document QA audits and facility inspections, in-life and otherwise, plus monitor lab activities plus against SOPs, method validation plans, study protocols, and FDA/ICH/EMA guidelines
                                                              • Maintain controlled, indexed regulated documents (e.g., Study and Method Registers, GLP Master Schedule, etc), archive onsite (including electronic), and send to (and retrieve from) off-site archive
                                                              • Author, review, and maintain SOPs, report templates, training plans, annual regulatory refresher training, data trending reports, etc
                                                              • Track, trend, and ensure quality and compliance of Corrective Action/Preventative Action (CAPA), Investigations, Deviations, and Change Controls
                                                              • Review computerized system validations, equipment maintenance, and calibration records
                                                              • Conduct assessments and handle information requests for clients, potential clients, suppliers and vendors, test facilities, clinical sites, etc
                                                              • Assist with maintaining current facility certificates and registrations, controlled substances, and safety program documentation
                                                              • Support management and business development or marketing activities, foster client relationships, and onboard new clients

                                                              Qualifications

                                                              • QA Candidates with small or large molecule bioanalytical experience in a deadline-driven and regulated GxP setting
                                                              • Knowledgeable in US FDA 21 CFR Part 58 (GLP), Part 11 Regulations and 2003 Guidance, FDA 2018 BMV Guidance, OECD GLP, US FDA & ICH GCP, EMA requirements, etc
                                                              • BS (3+ years experience) or MS (2+ years) degree in analytical chemistry, biochemistry, pharmacology, biotechnology, biomedical sciences, or related areas
                                                              • Hands-on experience with Sciex Mass Spectrometers and Analyst software, or ELISA, MSD, Luminex, and qPCR Assay platforms is a huge plus
                                                              • Excellent interpersonal communication and relationship building where all feel heard and respected
                                                              • Fast and continuous learner, flexible thinker, self-motivated doer who can independently manage responsibilities, take on new challenges, mentor and train others, and with demonstrated ability to thrive in a fast-paced environment
                                                              • Familiarity with Thermofisher’s Watson LIMS, Non-compartmental Analysis (NCA) on Certara’s WinNonlin, GMP, and CAP/CLIA regulations is desirable
                                                              • Proficient in Microsoft Office, Adobe Programs plus scientific and technical reading and writing

                                                              Compensation And Benefits

                                                              • Competitive compensation commensurate with industry experience
                                                              • Discretionary performance bonus and equity participation at year-end
                                                              • Two weeks paid annual vacation
                                                              • 401k match and healthcare coverage to eligible employees
                                                              • Accelerated career progression with flexibility to expand role and grow into the next level

                                                              Industry

                                                              • Biotechnology
                                                              • Pharmaceuticals
                                                              • Outsourcing/Offshoring

                                                              Employment Type

                                                              • Full Time

                                                              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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