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: 

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

Key Responsibilities:

  • Responsible for design, planning, execution and delivery of formulation and process development
  • Work with 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
  • Support data analysis of the development studies and provide technical assessment risk assessment
  • 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
  • Design and execute formulation and process characterization Ensures appropriate design principles including DOE are used where applicable. Ensures fit-for-purpose scale-down models are developed and employed
  • Optimization of formulation to support any change in clinical plan or clinical
  • 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
  • Eight-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
  • Dynamic, interactive, fast-paced and entrepreneurial environment
  • Domestic or international travel is required (10-20%)

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