Quality Manager, Bioanalytical Lab - Hamden, CT, USA

Company: NorthEast BioLab
Location: Hamden
Posted on: June 21, 2022

Job Description:

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.
Overview

• Collaborate with an interdisciplinary team to support high-quality bioanalysis activities while enabling life-changing, life-saving therapeutics
• Maintain regulator/sponsor trust for excellent bioanalytical study data on Pharmacokinetic (PK), Toxicology (Tox), Biomarker, Bioavailability (BA), Bioequivalence (BE), and other bioanalysis
• Champion quality and compliance with Good Laboratory Practices (GLP), Company Standard Operating Procedures (SOPs), and Sponsor Study protocols
  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
    Qualification
    • 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 and 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
        Other Job Details
        Seniority Level
        • Manager and Individual Contributor
          Industry
          • Biotechnology
            Employment Type
            • Full-time
              Job Functions
              • Quality
              • Management
                Work Remotely
                • No
                  Job Type: Full-time

Keywords: NorthEast BioLab, Hamden , Quality Manager, Bioanalytical Lab - Hamden, CT, USA, Executive , Hamden, Connecticut