The Role:

The Senior Director, Drug Product will report to the Executive Director (Device Engineering and Drug Product) and will be responsible for leading formulation and manufacturing process development, technical transfer and clinical/commercial manufacturing for drug product processes.  This position will work closely with drug delivery/device development to ensure the integrated development and manufacturing for combination product is in place. This position must work collaboratively with the various functional areas, including manufacturing operations, process and device development, analytical development, packing labeling, distribution, quality, regulatory and clinical operations, both internally and at CDMO/CMO companies. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will be a confident specialist with a proven track record in managing and leading drug product manufacturing for subcutaneous administration in the biotech and/or pharma industry.

Key Responsibilities:

• Lead the formulation development, process development, and manufacturing strategies in the design and implementation of stable formulations of monoclonal antibodies for subcutaneous administration via pre-filled syringe and vials;
• Provide oversight of ongoing drug product production for clinical and commercial processes, ensuring supply continuity.
• 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 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.
• Perform due diligence as needed on potential partners for fit synergies with the current portfolio.
• Provide oversight to combination product related activities and documentation
• Review analytical and clinical data to make scientific conclusions.
• Maintain current knowledge of regulatory environment, specifically requirements for CMC sections of clinical registration submissions
• 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.

Qualifications:

• PhD with 6+ years of experience, Masters with 10+ years of experience, or Bachelors with 12+ year of experience in pharmaceutical sciences, biochemistry or another relevant field;
• Relevant biopharmaceutical industry experience with experience in drug product manufacturing of biologics (monoclonal antibodies preferred) for subcutaneous administration;
• Depth of experience in formulation and drug product process development of biologics delivered subcutaneously;
• Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship;
• Proven leadership in management of CMO production;
• 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:

• The position will be remote;
• Dynamic, interactive, fast-paced, and entrepreneurial environment;
• Domestic or international travel required (10-20%)