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:
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work.
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel is required (10% - 20%)