Associate Director, Process Chemistry

IMMUNEERING CORPORATION•Cambridge, MA

1d•Remote

About The Position

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%).

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 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 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

Nice To Haves

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.), and ability to elevate relevant issues to project lead and line-management
Self-motivated, detail-oriented, with a continuous quality improvement mindset, high personal integrity, and excellent time management and organizational skills
Excellent communication, problem-solving skills; thrives in a cross-functional team environment

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