Associate Director, Process Chemistry (Remote)
Not Disclosed•Full-TimeRemote
location_onBig Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
About Immuneering
Immuneering is dedicated to advancing the field of drug development through innovative small molecule therapeutics. Our mission is to transform the drug substance manufacturing landscape by inventing novel, robust, and scalable synthetic routes that comply with rigorous regulatory standards. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect, and we do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status.
About the Role
As the Associate Director, Process Chemistry, you will serve as a pivotal leader overseeing the entire lifecycle of our small molecule drug substance manufacturing process development program, from candidate nomination through clinical development. Reporting to the Head of CMC, you will act as the primary technical expert for drug substance, guiding cross-functional teams to deliver quality materials for clinical trials within strict timelines.
This role is designed for a proactive team player with a deep background in organic chemistry and a proven track record of accomplishments. You will be responsible for inventing synthetic routes that are safe, robust, and cost-effective, while ensuring optimal process performance through advanced understanding, modeling, and characterization. Your day-to-day will involve managing relationships with CROs and CDMOs, evaluating and negotiating contracts, and driving the expansion of Immuneering's intellectual property portfolio. You will also play a critical role in authoring CMC sections for regulatory filings (such as IND, IMPD, NDA, MAA) and responding to agency questions, requiring exceptional technical writing skills and a strategic approach to regulatory compliance.
Hiring Process
Immuneering utilizes the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. We encourage individuals from all backgrounds to apply and join us in our mission. Please note that we do not accept unsolicited resumes from recruitment agencies; all resumes submitted without a prior written agreement will be considered property of Immuneering, and no fee will be paid in the event of a hire.
Work Environment
This position is remote-based within the US. However, the successful candidate must be available to travel to Immuneering work locations for company meetings and other work partner sites as needed, approximately 10 to 20% of the time. The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Work location
Work model: Remote
Big Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
San Diego, California
Key Responsibilities
- check_circleInvent synthetic routes and develop safe, robust, and cost-effective manufacturing processes
- check_circleReview and approve executed batch records and provide technical review for quality investigations
- check_circleEstablish critical quality attributes and critical process parameters for drug substances in development
- check_circleContribute to the expansion of the company's intellectual property portfolio for drug substances
- check_circleEvaluate, negotiate, and manage relationships with CROs and CDMOs for process development and manufacture
- check_circleDirect drug substance manufacturing process development, technology transfer, and manufacturing campaigns at external CDMOs
- check_circleEnsure optimal process performance through process understanding, modeling, and characterization
- check_circleServe as a drug substance subject matter expert for cross-functional project teams
Requirements
- verifiedPhD in chemistry, chemical engineering or related sciences with 8+ years of industry experience; or MS or BS degree with 12+ years of industry experience
- verifiedFoundational understanding of organic chemistry, solid form sciences, and process chemistry
- verifiedStrong understanding of synthetic organic chemistry reactions, techniques and processes
- verifiedExperience in small molecule drug substance process development, technology transfer and manufacture
- verifiedApplication of QbD principles to the drug development process
- verifiedExperience managing CDMOs for research, development and manufacturing campaigns
- verifiedSolid understanding of relevant FDA, EU, and ICH regulatory guidelines
- verifiedExcellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions
Nice to Have
Experience in IND/IMPD and NDA/MAA submissions. Experience with drug substance process validation. 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.
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Skills, education and keywords
Skills: Organic Chemistry, Process Chemistry, Synthetic Organic Chemistry, Solid Form Sciences, Quality BY Design, CGMP, Regulatory Submissions, Patent Applications, Process Analytical Technologies, Modeling And Simulation Tools.
Education: PhD in chemistry, chemical engineering or related sciences; MS in chemistry, chemical engineering or related sciences with 12+ years experience.
Frequently asked questions about Associate Director, Process Chemistry (Remote) at Big Bully Turf
What does a Associate Director, Process Chemistry (Remote) at Big Bully Turf do?expand_more
A Associate Director, Process Chemistry (Remote) at Big Bully Turf is responsible for the following: Invent synthetic routes and develop safe, robust, and cost-effective manufacturing processes; Review and approve executed batch records and provide technical review for quality investigations; Establish critical quality attributes and critical process parameters for drug substances in development; and Contribute to the expansion of the company's intellectual property portfolio for drug substances.
What are the requirements for this Associate Director, Process Chemistry (Remote) role?expand_more
Big Bully Turf is looking for candidates who meet the following requirements: PhD in chemistry, chemical engineering or related sciences with 8+ years of industry experience; or MS or BS degree with 12+ years of industry experience; 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; and Experience managing CDMOs for research, development and manufacturing campaigns.
Where is the Associate Director, Process Chemistry (Remote) role at Big Bully Turf located?expand_more
Associate Director, Process Chemistry (Remote) at Big Bully Turf is based in Big Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States. This is a remote role.
Is this Associate Director, Process Chemistry (Remote) job remote, hybrid, or on-site?expand_more
Big Bully Turf has listed this Associate Director, Process Chemistry (Remote) role as remote.
How much experience is required for this Associate Director, Process Chemistry (Remote) role?expand_more
Associate Director, Process Chemistry (Remote) at Big Bully Turf typically requires 8+ years of relevant experience at the lead level.
What skills do you need for the Associate Director, Process Chemistry (Remote) role at Big Bully Turf?expand_more
Key skills for Associate Director, Process Chemistry (Remote) at Big Bully Turf include Organic Chemistry; Process Chemistry; Synthetic Organic Chemistry; Solid Form Sciences; Quality BY Design; CGMP; Regulatory Submissions; and Patent Applications.
What education is required for Associate Director, Process Chemistry (Remote) at Big Bully Turf?expand_more
Educational requirements for this role: PhD in chemistry, chemical engineering or related sciences; and MS in chemistry, chemical engineering or related sciences with 12+ years experience.
What category does the Associate Director, Process Chemistry (Remote) role belong to?expand_more
Associate Director, Process Chemistry (Remote) at Big Bully Turf is part of the scientific & qa job category on Recrutus.