IMVT Corporation is hiring a Remote Associate Director Analytical Sciences & Technology
\nOrganizational Overview:\n\nImmunovant, 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.\n\nThe Role: The (Associate) Director, Analytical Sciences role is responsible for managing analytical development activities at contract testing laboratories for Immunovant Inc. This individual will work closely with other areas such as CMC Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory Affairs to manage the method development, transfer, validation, and trending at testing laboratories to ensure timelines coincide with process development and production schedules. The individual should be knowledgeable in stability of biologics, 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 incumbent will implement and oversee analytical strategies for drug product and device test methods, setting of specifications, and trending of method performance for release, and stability testing and data. The individual is knowledgeable regarding regulations, industry guidances, and global quality systems for methods and stability.\n\nKey Responsibilities: \n\n\n* 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.)\n\n* Implementation and life-cycle management of methods for testing raw materials, components, drug substance and drug product\n\n* Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems, and meet related regulatory requirements\n\n* Ensure contracted third-party testing laboratories are in compliance with appropriate quality and regulatory practices to meet the desired quality attributes of Immunovant\n\n* Author relevant CMC sections for regulatory submission documents\n\n* 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\n\n* Establish current and long-range plans and objectives required to assure quality and regulatory compliance.\n\n* Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to Immunovant; work to remediate any identified gaps\n\n* Maintain an active analytical risk register compliant with current Quality Risk Management practices\n\n\n\n\nRequirements:\n\n\n* 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 development through commercial products; experience in biologics including monoclonal antibodies is highly preferred\n\n* Advanced knowledge in analytical and microbiology methods pertaining to drug product vial, syringe, device is highly preferred\n\n* Experience with development, transfer, and validation activities are required. Demonstrated history of methods continuous improvement is desired\n\n* This role will involve oversight of method development and GMP testing at CMOs/ contract test laboratories as it applies to laboratory and stability functions. Demonstrated experience effectively managing projects with contract testing laboratories is highly preferred\n\n* Experience with, and a good understanding of, FDA and other key regulatory agency regulations and guidances including ICH guidance documents, is required.\n\n* 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\n\n* Broad knowledge of risk-based Quality Systemsโ components including Quality Risk Management is required\n\n* Knowledge of statistics including the use of JMP software is preferred\n\n* MS Office applications, Veeva QMS, Oracle, Empower, LIMS is highly preferred\n\n\n\n\nWork Environment:\n\n\n* Remote-based; will have access to Immunovantโs NYC/NC offices\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (< 10%)\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Testing and Travel jobs that are similar:\n\n
$95,000 — $137,500/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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