Immuneering Corporation

Director

• Oversee all aspects of the drug product development program from candidate nomination through clinical development
• Conduct pre-formulation studies, including API form characterization and selection, with Process Chemistry
• Design, execute and interpret formulation screening and excipient selection studies
• Define phase-appropriate formulation approaches balancing clinical needs, manufacturability, regulatory expectations and commercial considerations
• Develop robust, scalable and cost-effective drug product manufacturing processes
• Direct drug product process development, technology transfer and manufacturing campaigns at external CDMOs
• Review and approve process development protocols, master batch records, manufacturing campaign reports, executed batch records, quality investigations and batch disposition records
• Provide person-in-plant support for manufacturing campaigns as required
• Assist in establishing critical quality attributes and critical process parameters
• Author or review development reports and risk assessments
• Author assigned CMC sections for IND, IMPD, NDA and MAA filings and respond to regulatory agencies
• Serve as drug product subject matter expert for cross-functional teams
• Collaborate across CMC and the wider development team to deliver quality drug product for clinical trials
• Maintain technical expertise in formulation and process development
• Work in compliance with cGMP, safety and regulatory requirements
• Report to the Head of CMC

Associate Director, Formulation Development