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
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