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 compounds, batoclimab and IMVT-1402, are novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Both are optimized as a subcutaneous injection with potential flexibility in dosing and approach and are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
The Device Development Engineer, CMC will report to the Senior Director of Device Development 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 CMC team 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.
- 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).
- Manage the development of EU Medical Device Regulation (MDR) compliant project documentation and coordinate interactions with the Notified Body.
- 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
- 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
- Effectively manage multiple projects and responsibilities
- Track deliverables from team members and support associated action item
- Consistently perform duties within established SOPs and in accordance with GxP
- Bachelor's degree in science, engineering, or another relevant field; advanced degree beneficial
- Five years-plus years of relevant biopharmaceutical industry experience with 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
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)
We are driven by our vision of enabling normal lives for people with autoimmune diseases, and we embrace #allvoices by bringing a diverse and talented group of people together. We are committed to inclusion & equity across race, ethnicity, gender, age, religion, physical ability, identity, sexual orientation, and experience. We are an equal opportunity employer, and we welcome you to join us on this journey as your whole, authentic self.
Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $117,863-185,500.