Organizational Overview:
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 Role:
The Director, Downstream Process Development will report to the Sr. Director, CMC and will be responsible for leading downstream development of biologics (monoclonal antibodies). This individual will lead phase appropriate downstream development efforts including optimization, characterization and validation of purification process for multiple indications. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will be a confident downstream specialist with a proven track record in managing and leading biologic (monoclonal) programs through development and in support of licensure and commercialization.
Key Responsibilities:
- Lead the downstream development strategy and execution enabling consistent, high-yielding, high-purity and scalable downstream purification
- 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 downstream efforts; Partner with team members in the design of experiments incorporating Quality by Design (QbD) into the process characterization
- Responsible for technical leadership in technical issue resolution with CMO partners, including design of experiments and interpretation of results
- Lead process validation activities and strategies including evaluation of downstream process characterization plans from process validation protocol creation to report writing
- 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 process development
- Create and review technical documents, reports, and presentations for cross functional teams 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 downstream process development and implementation of biologics (monoclonal antibodies preferred) for subcutaneous administration
- Expertise in process design and development of downstream 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 downstream process approaches 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
Work Environment:
- Currently remote-based; will be located in Immunovant’s NYC office
- Dynamic, interactive, fast-paced and entrepreneurial environment
- May require up to 20% travel