Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.

The Role:

The Senior Director, CMC and Distribution Quality will be responsible for Quality Assurance activities in support of the development and commercialization of Immunovant’s biotherapeutic assets. The successful candidate will lead the CMC Quality Team in establishing and providing oversight to all processes related to the manufacturing, packaging, testing, transport, storage and distribution of Immunovant products.  This role will be a key member of the Quality Leadership Team and provide GMP and GDP related cross-functional expertise to the strategic quality direction of the organization.  In partnership with the Sr. Director of Quality Systems, ensure that the CMC processes seamlessly interface with those of the external Contract Manufacturing, Contract Packaging and Contracted 3PL organizations. The successful candidate must have a demonstrated history of Quality leadership in the late-stage clinical development and commercialization space.

Key Responsibilities: 

  • Lead, develop, and mentor direct reports, manage staff priorities, and direct activities of the  CMC and Distribution Quality group
  • Provide relevant CMC and Distribution Quality expertise into the cross-discipline Quality Leadership Team
  • Develop and direct risk identification and risk mitigation strategies for the outsourced manufacturing of biologic drug substance, sterile drug product, and combination products.
  • Develop relationships with and collaborative activities at partner CMOs, laboratories, 3PLs and internal key stakeholders in CMC and Analytical Sciences.
  • Develop and/or provide Quality Assurance review of development documents (records, experimental data, protocols, reports, SOPs, Change Controls, Deviations, etc.)
  • Partner with Process Development, Analytical Sciences, CMC regulatory, and Supply Chain, to develop and improve Immunovant business processes and quality systems
  • Review technical sections of Immunovant global regulatory submissions
  • Establish inspection ready processes as a primary SME in external 3rd party inspections and audits
  • Ensure appropriate compliance oversight and audit of relevant CMC and Distribution vendors.
  • Chair the cross-functional Materials Review Board 

Requirements:

  • BS or equivalent in Biology/Chemistry/Engineering/Pharmaceutics or another relevant field.
  • 15+ years of experience in the biotech industry with 5+ years demonstrated leadership.
  • Leadership experience in manufacturing related Quality Assurance including collaboration with external manufacturing organization.
  • Expertise in drug substance, sterile drug product and combination product Quality Assurance is required, medical device experience is a plus.
  • Direct experience with successful registrations, inspections, and commercial launch of biotherapeutic  moieties
  • Knowledge of cGMP and GDP regulations, and ICH guidelines, and world-wide health authority requirements
  • Ability to 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:

  • Remote-based; will have access to Immunovant’s NYC/NC offices
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • May require up to 25% travel

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