JOB SUMMARY:

Immunovant’s mission is to deliver value to patients in the treatment of autoimmune disease and other immunological disorders. The Process Development and Technical Operations organization has the primary responsibility for Chemistry, Manufacturing & Controls (CMC), Supply Chain, and rapidly developing and commercializing biologic/biopharmaceutical assets in support of Immunovant’s strategic objectives. 

A key activity in support of this goal is the development, qualification and validation of analytical / bioassays for monoclonal antibody testing and characterization. The candidate for this highly visible position should have demonstrated experience in early to late stage assay development, product characterization, comparability studies and associated regulatory filing experience. This individual will be responsible for interacting with Immunovant’s Contract manufacturing organizations (CMOs) to enable the timely development, transfer and implementation of analytical methods as well as management of all biologics in process, release testing and stability programs. As a member of the CMC Team, this person will work closely with Process Development, Technical Operations, Quality and Regulatory, as well as key external parties and stakeholders at partner companies. The individual will report to the Vice President and Head of CMC.

 

RESPONSIBILITIES:

• Develop and execute strategy for analytical / bioassay development and product characterization to support clinical development, manufacturing, process characterization and validation
• Lead and manage key scientific initiatives to develop short- and longer-term CMC analytical strategies
• Designs scientific approaches and use best industry practices in support of assay development, assay transfers and assay validation while maintaining compliance with GMP guidelines
• Ensures all analytical and specification reports are available and completed timely to support regulatory filings
• Maintain an awareness of CGMP’s, ICH, FDA and EMA regulatory guidelines
• Author, review, and approve CMC documentation for regulatory filings as well as attending pertinent regulatory meetings as the functional owner
• Manages CDMO’s and external consultants engaged in development and validation of methods, testing and characterization of dosage forms for biologics
• Apply technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track

 

QUALIFICATIONS:

Education & Experience:

•          Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences together with 12+ years’ experience in the biologics industry developing recombinant proteins and monoclonal antibodies.

• Demonstrated ability to successfully manage biologics programs through late stage clinical development and commercialization is required
• Proven track-record of technical excellence and product development
• Authorship of regulatory submissions and interactions with regulatory agencies
• Experience in formulation and / or device development a plus

Other skills/attributes:

• Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
• A keen ability and desire to grow an organization and help manage the dynamics of change
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Ability to navigate with limited supervision and be successful in a fast-paced work environment