Associate Director, Process Chemistry

Role Overview

• Invent synthetic routes and develop safe, robust, and cost-effective manufacturing processes
• Direct drug substance manufacturing process development, technology transfer and manufacturing campaigns at externa CDMOs, including development, review and approval of process development protocols, master batch records and manufacturing campaign reports
• Review and approve executed batch records, and provide technical review and approval for quality investigations and batch disposition records
• Assist in establishing critical quality attributes and critical process parameters for drug substances in development
• Ensure optimal process performance through process understanding, modeling and characterization, and process performance review
• Contribute to the expansion of Immuneering’s intellectual property portfolio for drug substances
• Author or revise development reports and risk assessments
• Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies
• Serve as drug substance SME for cross-functional project teams
• Collaborate within CMC and across the wider development team to deliver quality drug substance for clinical trials within required timelines
• Serve as a technical expert and keep current in the field of organic and process chemistry
• Possess a deep understanding of global regulatory requirements and emerging trends
• Maintain a working knowledge of manufacturers and suppliers of chemical raw materials, reagents, and intermediates capable of addressing the process requirements of the company in a timely and economical manner
• Evaluate, negotiate/establish contracts and manage relationships with CROs/CDMOs for drug substance process development and manufacture
• Work in compliance with cGMP, safety and regulatory requirements

Requirements

• PhD in chemistry, chemical engineering or related sciences with 8+ years of industry experience; or MS or BS degree in chemistry, chemical engineering or related sciences with 12+ years of industry experience
• A foundational understanding of organic chemistry, solid form sciences, and process chemistry
• Strong understanding of synthetic organic chemistry reactions, techniques and processes
• Experience in small molecule drug substance process development, technology transfer and manufacture
• Application of QbD principles to the drug development process
• Experience managing CDMOs for research, development and manufacturing campaigns
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to drug substance manufacturing, and current standards of practice in the industry
• Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies
• A critical and strategic thinker with exceptional decision making skills and the ability to work independently in a fast-paced, high-pressure setting
• Excellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions
• Values-based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture.

Benefits

• Travel: 10 to 20%
• Remote