Organizational Overview:

 

Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.

 

The Role: 

 

Immunovant is seeking a Director, Formulation Development. This individual will report to the Senior Director, Formulation and Device Development and will be responsible for late phase drug product development of biologics. This individual will work to successfully execute drug product development, commercialization studies and process validation at our external manufacturing sites.

 

Key Responsibilities: 

 

  • Design and execute process characterization activities. Ensures appropriate design principles including DOE are used where applicable. Ensures fit-for-purpose scale-down models are developed and employed
  • Be responsible for the technical management of the external drug product manufacturers
  • Manage multiple CROs and CMOs during various phases of drug development and manufacturing to ensure timely clinical supply
  • Work closely with Analytical team to monitor product quality and product stability.
  • Responsible for design, planning, execution and delivery of formulation and process development studies.
  • Provide support to the process performance qualification readiness activities and manufacturing protocols
  • Work collaboratively and cross-functionally with our functions to meet the organization goals
  • Optimization of formulation to support any change in clinical plan or clinical dosing.
  • In collaboration with regulatory, author relevant Chemistry, Manufacturing and Controls (CMC) sections for drug products and address Regulatory reviewer comments with data supporting responses to enable accurate and timely registrational submission

  

Requirements:

 

  • Masters or PhD (preferred) in engineering, chemistry, biological science or another relevant field
  • Ten-plus years of relevant biopharmaceutical industry experience working in development of biologics or drug/device combination products (prefilled syringe) ideally working on large molecule programs (monoclonal antibodies preferred) for subcutaneous administration
  • Working experience in phase-based design control activities with integrated risk management deliverables and engineering studies from research through registration and launch
  • Understanding of primary containers and their interactions with protein, in-depth knowledge of drug delivery, parenteral and protein formulation
  • 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%) 
This position has been filled.