[Hiring] Associate Director, Process Chemistry @IMMUNEERING CORPORATION

Role Description

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.
• Implementation of these routes at scale for early to late-stage development.
• A thorough understanding of the principles of quality by design (QbD).
• 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.

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 and can be remote based in the US, with travel to Immuneering work locations for company meetings and other work partner sites as needed (up to approximately 20%).

Qualifications

• 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.
• Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies.
• A critical and strategic thinker with exceptional decision-making skills.
• 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.

Requirements

• Experience in IND/IMPD and NDA/MAA submissions is highly preferred.
• Experience with drug substance process validation is highly preferred.
• Experience in developing patent applications.
• Experience in managing quality investigations.
• Experience with modern analytical techniques and process analytical technologies (PAT).
• Experience with modeling and simulation tools, and predictive analytics.
• Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.).
• Self-motivated, detail-oriented, with a continuous quality improvement mindset.
• Excellent communication and problem-solving skills; thrives in a cross-functional team environment.

Benefits

• Travel: 10 to 20%.
• Location: Remote.

Company Description

Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.