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 Senior Director Formulation Development will report to the Head of CMC Process Development & Technical Operations and will be responsible for leading formulation development of biologics (monoclonal antibodies). This individual will lead phase appropriate formulation and drug product process development for monoclonal antibody programs to advance the portfolio. This position will work collaboratively with the various functional areas within process and device development, analytical development, packing labeling, distribution, and regulatory and clinical operations. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will be a confident formulation specialist with a proven track record in managing and leading biologic pre-filled syringe formulations for subcutaneous administration in the biotech and/or pharma industry.
- Lead the development of formulation strategies in the design and implementation of stable formulations of monoclonal antibodies for subcutaneous administration via pre-filled syringe;
- Provide technical and scientific direction to CMOs and external laboratories to ensure project deadlines and performance standards are met;
- Lead the development/optimization of scalable, efficient, and cost-effective formulation efforts;
- Responsible for technical leadership in technical issue resolution with CMO partners, including design of experiments and interpretation of results;
- Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions;
- Oversee the development of technical transfer protocols and supervise the transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities;
- Review analytical and clinical data to make scientific conclusions;
- Create and review technical documents, reports, and presentations for cross functional teams;
- Manage SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices;
- Masters or PhD (preferred) in pharmaceutical sciences, biochemistry or another relevant field;
- Eight-plus years of relevant biopharmaceutical industry experience with experience in formulation of biologics (monoclonal antibodies preferred) for subcutaneous administration;
- Depth of experience in formulation development of biologics delivered via pre-filled syringe;
- Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship;
- Proven leadership in developing new formulations/processes and scaling them up for implementation;
- 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.
- The position will be located in Immunovant’s NY office
- Dynamic, interactive, fast-paced, and entrepreneurial environment;
- Domestic or international travel required (10-20%).