Associate Director, Analytical Sciences and Technology

The Role:

The Associate Director, Analytical Sciences role is responsible for managing analytical development activities at contract testing laboratories for Immunovant Inc. This individual will work closely with other areas such as CMC Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory Affairs to manage the method development, transfer, validation, and trending at testing laboratories to ensure timelines coincide with process development and production schedules. The individual should be knowledgeable in stability of biologics, statistics, and data management. Additionally, the role involves significant vendor oversight, primary raw data review, support for exceptions management (deviations, CAPAs, OOS/OOT) and change control. The incumbent will implement and oversee analytical strategies for setting of specifications, trending method performance for release and stability tests. The individual is knowledgeable regarding regulations, industry guidance, and global quality systems for methods and stability.

Key Responsibilities:

• 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

Work Environment:

• Remote-based; will have access to Immunovant’s NC offices
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (< 10%)