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, Analytical Sciences will be responsible for analytical activities in support of the development and commercialization of Immunovant’s biotherapeutic assets. The successful candidate will lead the development, transfer, implementation, and monitoring of analytical methodologies to enable the development and commercialization of a novel monoclonal antibody. This role will manage the Analytical Sciences group which is responsible for methods to support release testing, stability, and characterization of drug substance, drug product, a subcutaneously administered prefilled syringe (PFS), and an autoinjector (AI). This role will be a key contributor within the CMC organization and throughout Immunovant. The successful candidate must have a demonstrated history of analytical leadership in the late-stage clinical development and commercialization space.
Key Responsibilities:
- Lead, develop, and mentor direct reports, manage staff, and direct activities of the Analytical Sciences group
- Develop and direct strategies for analytical methodologies for monoclonal antibody programs to be delivered via PFS and AI including analytical comparability, technical transfer, method development, continuous improvement, method monitoring, and method validation
- Develop relationships with and oversee activities at partner CDMOs and laboratories
- Develop and/or provide technical review of development documents (records, experimental data, protocols, reports, SOPs, etc.)
- Partner with process, stability, regulatory, and quality organizations to develop and support Immunovant business processes and quality systems
- Author and review technical sections of Immunovant global regulatory submissions
Requirements:
- PhD or equivalent in Biology/Chemistry/Engineering/Pharmaceutics or another relevant field. Exceptionally strong Masters candidates will be considered.
- 15+ years of experience in the biotech industry with 5+ years demonstrated leadership.
- Leadership experience in managing analytical projects with contract testing labs and/or CDMOs.
- Expertise in analytical techniques used to assess protein characterization, stability, and techniques for evaluating high concentration protein formulations
- Direct experience with successful registrations and commercial launch of biotherapeutic moieties
- Knowledge of cGMP 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 20% travel