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 practicesRequirements:• 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