Associate Director, Process Chemistry
Immuneering Corporation
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • California • Massachusetts • United States
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Salary
💰 $170,000 - $210,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
synthetic routesdrug substance manufacturingprocess developmenttechnology transferquality investigationscritical quality attributesprocess performance revieworganic chemistrysynthetic organic chemistryQbD principles
Soft Skills
critical thinkingstrategic thinkingdecision makingindependent worktechnical writingleadershipintegrityethicscollaborationcommunication
Certifications
PhD in chemistryPhD in chemical engineeringMS in chemistryMS in chemical engineeringBS in chemistryBS in chemical engineering