Description
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 (Associate) Director, Analytical Sciences role is responsible for managing analytical development, method validation, and method transfer activities at contract testing laboratories for Immunovant Inc. The individual should be experienced in Bioassays and Molecular Biology methods for protein therapeutics and knowledgeable in biologics production, protein stability, statistics, and data management. Additionally, the role involves significant vendor oversight, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control. The individual will oversee programs for reference materials, assay controls, critical reagents and laboratory cell banks. The incumbent will work on setting of specifications, and trending of method performance for in-process, release, and stability testing and data. The individual is knowledgeable regarding regulations, industry guidances, and global quality systems for methods and stability, and will work closely with areas such as CMC Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory Affairs to ensure deliverables coincide with process development and production schedules and regulatory submissions.
Key Responsibilities:
- Provide analytical oversight and approval of cGMP documents (method qualification and validation protocols and reports, technical reports, transfer protocols, justification of specifications, etc.)
- Implementation and life-cycle management of methods for in-process, drug substance, and drug product samples as appropriate for clinical development and commercial phases
- Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements
- Ensure contracted third-party testing laboratories are in compliance with appropriate quality and regulatory practices to meet the desired quality attributes of Immunovant
- Author relevant CMC sections for regulatory submission documents
- Coordinate and/or participate in projects related to analytical responsibilities and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies
- Establish current and long-range plans and objectives required to assure quality and regulatory compliance.
- Monitor and assess emerging Quality and Regulatory requirements/issues and determines impact to Immunovant and works to remediate any identified gaps
- Maintain an active analytical risk register compliant with current Quality Risk Management practices
Requirements:
- Bachelor of Science in an analytical field and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations for Bioassays for development through commercial products; experience in biologics including monoclonal antibodies is highly preferred
- Advanced knowledge in bioassays/molecular biology / microbiology method development, transfer, and validation activities are required. Demonstrated history of continuous improvement is desired
- This role will involve oversight of method development and GMP testing at CMOs/ contract laboratories as it applies to laboratory and stability functions. Demonstrated experience effectively managing projects with contract testing laboratories is highly preferred
- Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidances including ICH guidance documents is required, especially as pertain to product potency methodology.
- Full understanding of GMPs and the pharmaceutical development process is required as well as transfer of processes and methods from development to clinical manufacturing to commercialization is necessary
- Broad knowledge of risk-based Quality Systems’ components including Quality Risk Management is preferred
- Knowledge of statistics including the use of JMP software is preferred
- MS Office applications, Veeva QMS, Oracle, LIMS is highly preferred
Work Environment:
- Remote-based; will have access to Immunovant’s NYC/NC offices
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (< 10%)
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