Associate Director, Process Chemistry; Remote

Position: Associate Director, Process Chemistry (Remote)
Position Summary

The Associate Director, Process Chemistry will be responsible for overseeing all aspects of Immuneering's small molecule drug substance manufacturing process development program, from candidate nomination through the clinical development stage of the product lifecycle. This position requires experience in inventing novel, robust, efficient and scalable synthetic routes that comply with all relevant regulatory requirements, and implementing them at scale for early to late-stage development.

This position also requires a thorough understanding of the principles of quality by design (QbD), and extensive experience in scientific technical writing for drug development and regulatory submissions. Prior experience managing small molecule drug substance process development and manufacture at CROs and CDMOs is also critical for this position. The successful candidate will be a highly motivated, proactive team player with a strong background in organic chemistry and a proven track record of accomplishments.

This position will report to the Head of CMC. This position can be remote based in the US but the hired individual must be available to travel to Immuneering work locations for company meetings and other work partner sites as needed (up to approximately 20%).

Job Functions and Responsibilities

• 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

Education, Skills and Qualifications

Required:

• 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 principes 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…