Associate Director, Analytical Sciences – Technology

Job Description: • Provides analytical oversight and approval of cGMP documents (change controls, deviations, CAPAs, method qualification and validation protocols and reports, transfer protocols, justification of specifications, etc.) • Implementation and life-cycle management of methods for testing raw materials, components, drug substance and drug product • Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements • Author relevant CMC sections for regulatory submission documents • Coordinate and/or participate in projects related to analytical responsibilities and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies • Work alongside analytical characterization (subject matter) expert and support protocol, data, and report review and finalization. • Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to Immunovant; work to remediate any identified gaps • Maintain an active analytical risk register compliant with current Quality Risk Management practices Requirements: • Bachelor of Science in biology/chemistry/biochemistry field and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations for development through commercial products; experience in biologics including monoclonal antibodies is highly preferred • Knowledge of antibody structure and heightened analytical characterization methods is highly preferred • Experience with development, transfer, and validation activities are Demonstrated history of methods continuous improvement is desired • This role will involve oversight of method development, method validation and support GMP testing at CMOs/ contract test laboratories as it applies to laboratory and stability Demonstrated experience effectively managing projects with contract testing laboratories is highly preferred • Strong organizational and communication skills • Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidance including ICH guidance documents, is required. • Full understanding of GMPs and the pharmaceutical development process is required, as well as transfer of processes and methods from development to clinical manufacturing to commercialization is necessary • Broad knowledge of risk-based Quality Systems’ components including Quality Risk Management is required • Knowledge of statistics including the use of JMP software is preferred • MS Office applications, Veeva QMS, Oracle, Empower, LIMS is highly preferred. Benefits: • full range of medical, dental, vision • 401k • unlimited paid time off • parental leave Apply tot his job