Organizational Overview:

Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.

The Role:

The Director, Validation will be responsible for supporting lifecycle activities associated with the production of a biologic (monoclonal antibody) therapy and delivery by a subcutaneous prefilled syringe (PFS) and autoinjector (AI). This role will provide scientific and technical support to Immunovant’s drug substance and drug product third-party manufacturing, developing qualification/validation plans and documentation (e.g. protocols and reports) satisfying internal and external regulatory expectations. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate must be a confident validation engineer capable of driving results in a fast-paced, dynamic environment. 

Key Responsibilities:

  • Lead the development and execution of validation procedures and templates to standardize approaches to preparation, execution, and reporting of activities
  • Ensure compliance with regulatory agency requirements, internal company standards and review of SOP’s and validation master plans
  • Author and/or review technical documents related to health authority submissions, PPQ deliverables, technology transfer, process monitoring, and non-conformance (deviations/investigations) to support process transfer and ongoing manufacturing
  • Develop, review, and implement modifications to company engineering and validation policies and procedures to achieve corporate goals and objectives
  • Direct the development of strategic validation programs/initiatives, determine metrics for
  • program success, and evaluate performance
  • Ensure processes and systems are current with industry best practices and regulatory expectations
  • Assist with preparation of regulatory filings, answering questions from regulatory agencies and with presentation/review of materials during inspections/audits
  • Coordinate process validation activities performed at multiple locations including contract laboratories and contract manufacturing facilities

 

Requirements:

  • Bachelors or advanced degree in a technical discipline (physical, engineering, chemical or biological sciences
  • Six-plus years of relevant biopharmaceutical experience working in a cGMP regulated environment with exhibited knowledge in process validation, process sciences and change control
  • Strong understanding of the Product Life Cycle, with reference to industry standards and guidelines related to validation activities
  • Experience with manufacturing or process development within the pharma/biotech industry, preferably in complex biologics and combination products
  • Involvement in preparation of regulatory submissions and interaction with health authorities
  • Experience in the development and execution of validation protocols in a biopharmaceutical environment
  • Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
  • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
  • Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
  • Ability to think outside of the box and challenge the status quo
  • Natural entrepreneurial spirit with unrelenting dedication to delivering results
  • Desire to work in a fast-paced, innovative environment
  • Natural collaborator who enjoys working on a cross-functional team.

 

Work Environment:

This position has been filled.