Organizational Overview:
Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.
The Role:
The Director, Analytical Sciences will be responsible for leading the development of innovative analytical methodologies to enable the development of a novel monoclonal antibody drug product. This role will develop methods to support release testing, stability, and characterization of a subcutaneous prefilled syringe (PFS) and an autoinjector (AI) for the delivery of a biologic (monoclonal antibody) therapy. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate must be a confident analytical scientist with a history of planning and successfully executing analytical strategies to support product development and product submission.
Key Responsibilities:
- Lead the development of stable analytical methodologies for monoclonal antibody programs to be delivered via PFS and AI
- Drive analytical testing support for late-stage process development teams to assist in the development and analytical characterization and improved manufacturing process steps
- Work closely with partner CMOs and partner laboratories for qualification and validation of analytical methods in line with current ICH guidelines
- Develop and implement analytical methods utilized for both formulation development as well as methods for the release and shelf-life assessment of clinical supplies and the autoinjector device.
- Author/Review development reports, study protocols, and respective reports, SOPs and validation reports
- Evaluate CRO/CMO test results and write summary reports of the results when necessary
- Develop strategies to transfer analytical methods across external partners
- Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems and meet related regulatory requirements
Requirements:
- Bachelors, Masters or PhD (preferred) in Biology, Chemistry, Engineering, Pharmaceutics or another relevant field
- Six-plus years of relevant biopharmaceutical industry experience working in analytical and formulation development of biologics, ideally with experience in prefilled syringe and autoinjector devices for subcutaneous administration
- Expertise in analytical techniques used to assess protein stability and familiarity with techniques for evaluating high concentration protein formulations
- Working knowledge of regulatory guidelines governing device development
- Experience with Design of Experiments and statistical principles for experimental design and data analysis
- 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 environmen
- Natural collaborator who enjoys working on a cross-functional team.
Work Environment:
- Currently remote-based; will be located in Immunovant’s NYC office
- Dynamic, interactive, fast-paced and entrepreneurial environment
- May require up to 20% travel