Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
The Head of CMC Process Development & Technical Operations will be responsible for CMC activities and the Supply Chain for a rapidly developing and commercializing biopharmaceutical assets in support of Immunovant’s strategic objectives. You will provide oversight and technical management for process development activities, which includes oversight of upstream, downstream, drug product and device process development conducted at CROs/CDMOs, process optimization using DOE, technology transfer, clinical manufacturing, supply management, validation, and QbD regulatory filings. In cooperation with finance, you will direct the process development and technical operations program budget as needed to deliver the company’s development programs on schedule
- Direct drug substance/product/device process development and supply chain operational activities for the company’s biologics programs. Work closely with external CROs/CDMOs, collaborators, and/or partners to rapidly advance programs to key decision points.
- Develop and direct strategies for upstream and downstream process development, analytical development, formulation development and device development (including management of associated external CDMOs/CROs).
- Author and review technical sections for company’s global regulatory submissions (INDs, IMPDs, BLAs, MAAs, Meeting Requests, Briefing Documents, responses to Health Authority questions, etc.) related to assigned programs.
- Collaborate with QA and other members of the project team to efficiently evaluate, select, and manage contract service providers (CDMOs and CROs), including technology transfer, process scale-up, design of validation strategies, packaging development, and technical expertise with regards to routine/non-routine development and cGMP activities (e.g., deviations/investigations, process improvements, change controls, shelf-life extensions, CAPAs, etc.).
- Oversee the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work.
- Develop and/or provide technical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.).
- Leadership role in the creation, maintenance, improvement and compliance with of Quality System.
- Contribute to the generation and protection of company intellectual property.
- Lead, develop and mentor direct reports
- Ph.D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field. Exceptionally strong Masters candidates will be considered.
- 15+ years’ experience in the pharmaceutical or biotech industry with 5+ years demonstrated leadership in biologics process development.
- Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage biologics, including upstream/downstream process development, formulation development, analytical development and device development.
- Leadership experience in managing diverse project activities with contract CDMO facilities at different global locations
- Direct experience with successful registrations and commercial launch of cell-based product(s) and strong knowledge base of classical biologics process including USP, DSP, F&F, and packaging operations
- Experience with clinical supply management, process scale-up and technology transfer, cGMPs, ICH guidelines, as well as the CMC content of global regulatory submissions
- Experience with biologics development programs, from early-stage through commercial.
- Experience with parenteral products, including pre-filled syringes and devices.
- Knowledge of cGMP regulations required
- Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results
- Demonstrated communication, problem-solving, and negotiation/decision-making skill
- 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 New York office
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)