Associate Director, CMC Upstream Process Development and Technical Operations

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:

Reporting to the Senior Director, CMC Upstream Process Development and Technical Operations, this position is responsible for supporting development, optimization, manufacturing science and technology oversight, and supporting technology transfer of biologics (monoclonal antibodies). This individual will support phase-appropriate upstream efforts including development, optimization, characterization, and validation of biological processes. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will be a confident upstream specialist with a proven track record in managing and leading biologic (monoclonal) programs through development and in support of licensure and commercialization.

Key Responsibilities: 

• Support the upstream process development strategy and execution enabling consistent, high-yielding, and scalable processes
• Provide technical and scientific direction to CMOs and external laboratories to ensure project deadlines and performance standards are met
• Support the upstream development/optimization of scalable, efficient, and cost-effective processes; Apply scientific and engineering principles to support process scaling for cell culture operations and partner with team members in the design of experiments incorporating Quality by Design (QbD) into process characterization and optimization studies
• Responsible for technical leadership in technical issue resolution with CMO partners, including technical transfer, design of experiments, and interpretation of results
• Utilize product and process knowledge to author Upstream Process Control Strategy and monitor/trend process performance to establish/improve process capability.
• Support upstream process validation activities and strategies including establishing and evaluating process characterization plans, overseeing execution at CMO, reviewing and approving CMO reports
• Manage data and oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions
• Analyze and interpret results and methods, troubleshoot processes, generate solutions to problems and meet regulatory expectations for upstream process development
• Create and review technical documents, reports, and presentations for cross-functional teams. Review and approve cGMP batch documentation (e.g., master batch records, component specifications, validation protocols, material specifications) required to support cGMP production at manufacturing facilities.
• Manage related SOPs, change controls, deviations, and CAPAs with thorough knowledge of Good Manufacturing Practices

Requirements:

• Masters or PhD (preferred) in engineering, chemistry, biological science, or another relevant field
• Eight-plus years of relevant biopharmaceutical industry experience with experience in upstream process development, technical transfer, and implementation of biologics (monoclonal antibodies preferred) for subcutaneous administration
• Expertise in process design and development approaches with a thorough understanding of regulatory requirements
• Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship
• Proven leadership in developing and optimizing upstream processes, scaling them up for implementation, and transferring them to CMOs
• Ability to work 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
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (10-20%)

Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $177,000.00 - $189,000.00.