Organizational Overview:
Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
The Role:
Immunovant is seeking a Director, CMC Quality Assurance (QA) to play a key quality role in ensuring high quality/regulatory compliance during the cGMP manufacture of IMVT-1401, in strategic partnership with critical global service providers. The individual in this position will have the unique opportunity to help grow and shape the IMVT- 1401 Quality processes including those supporting sterile drug product manufacture and clinical packaging at a rapidly growing biotechnology company.
This position will contribute to Immunovant’s success by managing CMC QA activities under the guidance of the Sr. Director, CMC & Distribution Quality, while working closely with internal functions at Immunovant and external strategic manufacturing and testing vendors.
The Director, CMC QA provides QA oversight and direction for Immunovant CMC Drug Product and Device Development operations to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate. In addition, this role provides partners both internally and externally to drive process continuous improvement and mitigation activities pertaining to manufacture and packaging of investigational materials for clinical trials while and ensuring a culture of quality and compliance through effective leadership and strong adherence to Immunovant core values.
Key Responsibilities:
- Provide strong technical leadership in support of activities governed by global Good Manufacturing Practices (GMPs) regulations and guidelines
- Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s, CMOs and Packaging Facilities
- Drive process and product quality through effective CMC quality systems, ensuring adequate supplier oversight/surveillance
- Approve Protocol and Reports, Master Batch Records and Executed Batch Records for Drug Product manufacturing including sterile combination product filling and packaging
- Ensure Process Control Strategy implementation and adherence
- Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate
- Disposition batches for human use in Clinical Trials
- Ensure that Immunovant and its partners are inspection-ready for health authority audits by regulatory agencies; lead engagements with health authorities
- Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures
- Oversee development and maintenance of internal manufacturing and operational SOPs related to GxP activities, with primary focus on cGMP regulations and sterile material manufacturing.
- Partner with internal Device Development in the implementation, maintenance and compliance of Design History Files
- Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements including medical device and combination products
- Responsible for driving efficiencies and supporting the overall manufacturing process including process development activities, device development activities, and sterile drug product manufacturing (filling, labeling, packaging, and distribution)
- Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DS/DP release and CAPAs
- Perform other quality-related responsibilities in support of the QLT as necessary
Requirements:
- Bachelor or master’s degree in Biology, Chemistry, Engineering, or related fields
- A minimum of eight (8) years of GMP experience with a focus on Quality Assurance (QA) with substantial operational experience in sterile drug product manufacture;
- A minimum of five (5) years in roles of increasing responsibility in a biopharmaceutical environment; a minimum of two (2) years managing sterile drug product/sterile drug product facilities; commercial experience optimal
- Strong communication skills: oral/written and listening
- Experience interacting with FDA and global regulatory bodies/health authorities; pre- approval readiness (PAI) for commercial manufacturing
- Experience in medical device, combination product and commercial biologics strongly preferred
- Experience with clinical or commercial distribution processes is a bonus.
Work Environment:
- Remote location
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic and international travel is required (up to 35%) including required quarterly onsite meetings
