Associate Director Analytical Sciences & Technology Bioassay

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Organizational Overview of Immunovant, Inc.

Immunovant, Inc. is a clinical-stage immunology company that is a pioneer in anti-FcRn technology. The organization is committed to developing advanced therapies designed to transform the lives of individuals suffering from autoimmune diseases. Their goal is to administer normal lives for these patients by focusing on the complexities of their conditions and formulating targeted treatments.

The Role of (Associate) Director, Analytical Sciences

The (Associate) Director, Analytical Sciences at Immunovant is tasked with managing analytical development, validation, and transfer activities in coordination with external testing laboratories. A significant part of the role requires experience in Bioassays and Molecular Biology methods for biologics, along with a background in protein therapeutics. The candidate must possess an understanding of biologics production, protein stability, statistics, and data handling. Moreover, responsibilities include overseeing third-party vendors, managing exceptions such as deviations and out-of-specifications/results, as well as initiating change control procedures.

The individual's responsibility extends to managing programs concerning reference materials, assay controls, and critical reagents needed for laboratory cell banks. They will also be involved in setting specifications and analyzing method performance for various testing procedures across in-process, release, and stability stages. The individual should be knowledgeable about regulations, and global quality systems, and must collaborate with CMC Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory Affairs teams to align deliverables with regulatory submissions and production schedules.

Key Responsibilities

The key responsibilities of the role encompass analytical oversight, managing method life-cycle, interpreting results, troubleshooting processes, authoring regulatory submission documents, proposing improvements to Quality Systems, and maintaining compliance. Moreover, the role involves conducting strategic long-term planning to assure continual quality and regulatory compliance and staying updated with Quality and Regulatory requirements to address any identified gaps.

Requirements

Prospective candidates must have a Bachelor of Science degree (or advanced degrees) with substantial experience in analytical and/or QC operations, specifically with Bioassays and biologics. A strong background in method development, transfer, and validation activities is imperative. Experience with FDA and other regulatory agencies' guidances, full understanding of GMPs, and knowledge of Quality Systems are essential. Proficiency in statistics software, MS Office applications, Veeva QMS, Oracle, and LIMS is also highly desired.

Work Environment

The role is remote-based, with access to Immunovant's NYC/NC offices. The work environment is described as dynamic and fast-paced, requiring less than 10% of domestic or international travel.

Company: IMVT Corporation
Location: New York City, New York, United States

This job offer was originally published on RemoteOK

Resources

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