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Immunovant, Inc. is a company at the forefront of developing novel therapies for autoimmune diseases. They are pioneering the anti-FcRn technology aiming to restore the normal life quality for individuals affected by these conditions. Focusing on the distinctive needs of patients, Immunovant is making significant strides in the clinical-stage immunology landscape.
The position of (Associate) Director, Analytical Sciences is a key role within Immunovant, Inc. that involves managing the analytical development activities at third-party laboratories. This includes collaboration across various departments to ensure testing methods are developed, transferred, and validated in line with production requirements. Candidates should possess experience with biologics, a strong foundation in statistics, and adeptness in data management. Furthermore, the role requires significant vendor management, troubleshooting, exception handling, change control, and the implementation of analytical strategies for testing drug products.
The responsibilities encompass providing analytical oversight, managing testing methods for various materials, and interpreting analytical results. The incumbent must also maintain compliance with quality and regulatory standards, author CMC regulatory documents, and ensure adaptation to evolving regulations. The position involves establishing objectives to meet quality requirements, maintaining an analytical risk register, and driving continuous improvement.
A suitable candidate requires a bachelor’s degree in an analytical field along with extensive experience in biopharmaceutical analytical operations, especially with biologics. In-depth knowledge of specific analytical and microbiology methods, as well as a thorough understanding of FDA and other regulatory guidances, is essential. A holistic understanding of GMPs and the drug development process is also required. Additional expertise in Quality Risk Management and statistical tools would be beneficial.
The role is remote-based with access to offices in New York City and North Carolina, offering a dynamic and interactive setting. It may involve occasional domestic or international travel.
IMVT Corporation is rooted in New York City, carrying a mission to confront and solve challenges faced by those with autoimmune diseases, endeavoring to enable them to lead normal, healthy lives.
This job offer was originally published on RemoteOK
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This job offer summary has been generated using automated technology. While we strive for accuracy, it may not always fully capture the nuances and details of the original job posting. We recommend reviewing the complete job listing before making any decisions or applications.
