Associate Director, Analytical Sciences and Technology

Role Summary

Associate Director, Analytical Sciences responsible for managing analytical development activities at contract testing laboratories, coordinating with CMC Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory Affairs to manage method development, transfer, validation, and trending to align with development and production timelines. Oversees vendor interactions, raw data review, exception management, and change control, and implements analytical strategies for specifications and method performance for release and stability.

Responsibilities

• Provides analytical oversight and approval of cGMP documents (change controls, deviations, CAPAs, method qualification and validation protocols and reports, transfer protocols, justification of specifications, etc.)
• Implementation and life-cycle management of methods for testing raw materials, components, drug substance and drug product
• Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements
• 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
• Work alongside analytical characterization (subject matter) expert and support protocol, data, and report review and finalization.
• Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to Immunovant; work to remediate any identified gaps
• Maintain an active analytical risk register compliant with current Quality Risk Management practices

Qualifications

• Required: Bachelor of Science in biology/chemistry/biochemistry and 6 years (or MS with 5 years, PhD with 4 years) of experience in biopharmaceutical analytical and/or QC operations for development through commercial products; experience in biologics including monoclonal antibodies is highly preferred
• Preferred: Knowledge of antibody structure and heightened analytical characterization methods
• Required: Experience with development, transfer, and validation activities; demonstrated history of methods continuous improvement is desired
• Required: Oversight of method development, method validation and support GMP testing at CMOs/contract test laboratories as it applies to laboratory and stability; demonstrated experience effectively managing projects with contract testing laboratories is highly preferred
• Required: Strong organizational and communication skills
• Required: Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidance including ICH guidance documents
• Required: Full understanding of GMPs and the pharmaceutical development process; transfer of processes and methods from development to clinical manufacturing to commercialization
• Required: Broad knowledge of risk-based Quality Systems’ components including Quality Risk Management
• Preferred: Knowledge of statistics including the use of JMP software
• Preferred: MS Office applications, Veeva QMS, Oracle, Empower, LIMS

Education

• Bachelor of Science in biology/chemistry/biochemistry

Additional Requirements

• Remote-based; will have access to Immunovant’s NC offices
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (< 10%)