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 Device Development Engineer, CMC will report to the Senior Director of CMC and will be responsible for providing development support for medical device and CMC risk management to drive success of the drug development programs. The Device Development Engineer will work collaboratively with the various functional areas within process and device development, analytical development, packing labeling, distribution, and regulatory and clinical operations to ensure planning and completion of appropriate device deliverables and documentation. This individual will also provide oversight of CMOs and must understand process development and optimization, technology transfer, clinical manufacturing, supply management, validation, and QbD principles. In cooperation with the Senior Director of CMC this person will be responsible to deliver the company’s device development programs on schedule. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will be a confident technical resource with a proven track record of execution that supports project success for projects within CMC in the biotech and/or pharma industry.

Key Responsibilities: 

  • Work closely with functional areas to develop and maintain design history file documentation for medical device development.
  • Manage the creation and documentation of risk management files across all CMC activities (upstream, downstream, formulation, device, packaging, labeling, and distribution).
  • Assist with the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work
  • Understand and communicate deliverables, goals, and challenges appropriately to the broader CMC organization
  • Partner with functional areas to develop appropriate prioritization plans and appropriately escalate changes in resource demand, risks, gaps, or challenges
  • Facilitate completion of testing activities external development at contract research organizations
  • Support and author device related sections of US and European Regulatory submissions
  • Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals
  • Effectively manage multiple projects and responsibilities concurrently
  • Track deliverables from team members and support associated action item management
  • Consistently perform duties within established SOPs and in accordance with GxP requirements

Requirements: 

  • Bachelor's degree in science, engineering, or another relevant field; advanced degree beneficial
  • Six years-plus years of relevant biopharmaceutical industry experience with significant experience in medical device development
  • Experience with global pharmaceutical or device development and manufacturing operations for development-stage biologics, including upstream/downstream process development, formulation development (pre-filled syringe) and analytical development.
  • Knowledge of US and European device regulations and submissions with direct experience in bringing devices through approval in those markets
  • Experience managing diverse project activities with contract CMO facilities at different global locations; Experience with process development, process scale-up, and technology transfer
  • Strong computer skills including MS Office (MS Project)
  • 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 are required (10-20%)

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