Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

The Senior Director, Manufacturing Science and Technology (MSAT) is a key member of the CMC team reporting to the Vice President of CMC. The Senior Director, MSAT is an experienced and dynamic professional with capabilities to provide strategic direction and technical leadership for tech transfer, scale up, validation, and trending, monitoring, and troubleshooting of drug substance, drug product, and device manufacturing processes at our contract manufacturing organization’s (CMO) sites. In addition, this individual will lead the support of CMO in the closure of investigations, deviations, and change controls. Experience in troubleshooting and trending process and analytical data is a plus. The successful candidate will work closely with Process SMEs, CMC Project Management, Global Supply Chain, Quality, and Regulatory colleagues.
The successful candidate will have proven experience in leading internal CMC teams and managing external teams consisting of licensed partners, CROs, and CMOs. This leader will possess a deep understanding of cell culture, downstream processing, drug product manufacturing, and device assembly to lead investigation efforts on new and existing products. This is a leadership position with responsibility to build and supervise a team of junior scientists/engineers.
This role will be a key contributor within the CMC organization and throughout Immunovant. The successful candidate must have a demonstrated history of GMP manufacturing support leadership in the late-stage clinical development and commercialization space.

Key Responsibilities: 

• Strong leadership skills including people management and executive presence.
• Collaborate with CMC, Regulatory, Quality, Clinical Operations, and Supply Chain to develop and manage product lifecycle strategies.
• Perform due diligence as needed on potential partners for fit and synergies within the current portfolio.
• Responsible for the design and management of validation studies, protocol development, data evaluation, preparation, and review and approval of study reports to support drug substance and product regulatory submissions section.
• Provide strategic oversight for drug substance and drug product manufacturing, device assembly, and supporting analytical/Quality Control laboratory operations.
• Author and/or review protocols, development reports, batch records, standard operating procedures, and other technical reports to support regulatory filings.
• Manage complex investigations where analysis of situations or data requires an in-depth evaluation of various factors.
• Lead the development/optimization of scale-up/scale-down efforts to support on-going manufacturing.
• Lead the development of in-process control strategies.
• Work effectively in a cross-functional matrix environment, with both internal and external collaborators and proactively communicate with internal and external stakeholders.
• Collaborate with internal resources, partners, consultants, and vendors for all technical operations related activities
• Supports quality and regulatory activities including site inspections, preparation of technical documents for BLA supplements, FDA observations, and all processing-related issues
• Maintain current knowledge of regulatory environment, specifically including requirements for CMC sections of clinical and registration submissions.
• Ability to guide dose presentation strategy development and responsible for understanding and applying data generated from experiments used to modify/optimize formulations.

Requirements:

• Minimum 10 years of experience in an FDA-regulated environment
• Minimum 7 years of experience in Manufacturing Science and Technology within the Pharmaceutical industry with an emphasis on monoclonal antibody manufacturing
• Demonstrated project management skills
• Demonstrated leadership and teamwork skills
• Excellent analytical and communication abilities
• Good understanding of process validation concepts and experience with technical transfer preferred
• Must have strong interpersonal skills, strong customer focus given the need to integrate activities with CMOs, cross-functional and collaborative partners
• Excellent presentation skills and the ability to concisely describe complicated issues to leadership team
• Must have hands on experience with drug manufacturing scale up, technical transfer, product process optimization and improvements
• Thorough understanding of commercialization process
• Direct experience with successful registrations and commercial launch of biotherapeutic moieties
• Knowledge of cGMP regulations, 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 25% travel