Main Accountabilities and tasks Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, OfficeThe Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific and technical expertise for QC and transfer activitiesThese activities include the timely qualification of in-process and release testing of drug delivery systems, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratoryThe manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectlyReview and approval of customer manufacturing batch recordResponsibilities include hiring, training, goal setting, and performance evaluationThe manager collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditionsAdditionally, the manager serves as the primary technical liaison with clients and Regulatory BodiesLead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testingBuild a trained, competent team of QC analysts to support GMP testingCoordinate any required daily Quality Control activitiesEnsure compliance, accuracy, and timeliness of testing processesLead the introduction of new technology, equipment, methodologies, and validationsProvide QC leadership and support across the organizationHire and develop employees within the departmentAssign work, coach staff, and take vital disciplinary actionsServe as primary QC Bioanalytical contact for regulatory inspections and client auditsProvide support for method qualification and validation from Assay Development and Analytics and/or clientsProvide frequent overall departmental feedback to senior managementEnsure adequate staffing is hired and trained
