Job Description

We are seeking an experienced Principal Scientist, Chemical Development to join our dynamic team to help advance our pipeline of innovative targeted cancer therapies. The successful candidate will apply their expertise in small molecule process development and manufacturing to support a variety of modalities in the Immunome pipeline with a focus on small molecule linker-payload targets for ADCs. This person will play a key role in leading challenging drug candidate process development programs, enabling treatment of patients in need.

Responsibilities

Leadership

• Provide technical leadership as a key member of the chemical development team while maintaining alignment with the company's goals and objectives
• Function as the technical lead on at least one program while also functioning as an individual technical contributor.
• Provide guidance and leadership to external partners working towards the successful advancement of antibody drug conjugates, radiopharmaceuticals, and other lead programs.
• Support programs at the bench as an individual contributor as needed.

Technical Expertise

• Leverage knowledge and experience in the development and execution of robust and scalable small molecule synthetic processes.
• Devise and evaluate alternative routes of synthesis with the aim of developing robust and efficient routes to APIs while reducing cost of goods (COGs) and shortening manufacturing lead times.
• Develop robust data packages for technical transfer of processes for manufacturing partners at external CMOs.
• Maintain knowledge of the current state of the art in synthetic methods utilized for the construction of complex molecules.
• Carry out thorough analytical data collection both as an individual contributor in the lab as well as via oversight and review of data collected at our external partners
• Contribute to authoring relevant sections of various regulatory documents (IND, IMPD, NDA, briefing books, etc.) and provide SME support for related regulatory inquiries.

Cross-Functional Collaboration

• Execute the integrated CMC regulatory strategies for pipeline programs.
• Collaborate with research, regulatory affairs, and CMC teams to ensure seamless coordination of activities.
• Provide feedback to research on synthetic routes and raw materials that are CMC friendly.
• Foster strong collaborations with internal and external stakeholders.
• Engage colleagues in discovery chemistry to provide CMC input of target molecules under evaluation for future development.

Innovation

• Stay abreast of the latest advancements in synthetic methodology as well as new technologies and methodologies to enhance our capabilities.
• Advance Immunome’s intellectual property portfolio.

Quality and Compliance

• Ensure compliance with relevant regulatory guidelines and industry standards for chemical development processes.
• Uphold high-quality standards and address any compliance issues.

Qualifications

• PhD in Synthetic Organic Chemistry or similar with a minimum of 7 years of industry experience leading small molecule and/or linker-payload programs, or equivalent combination of education and experience.
• Experience as a technical lead overseeing tech transfer, process development and implementation of processes for manufacture at internal and/or external manufacturers is a plus.
• Occasional evening and/or weekend commitment.
• Ability to travel domestically and internationally (5-15%).

Knowledge and Skills

• Ability to design cost effective robust manufacturing processes for complex small molecule targets as well as troubleshoot and solve complex technical challenges quickly.
• Brings a collaborative and open-minded attitude when working with various internal and external teammates.
• Meticulous and detail-oriented scientist with the ability to operate as an individual contributor at the bench while also managing external partners.
• Proficient in generating robust and reliable analytical data utilizing various technologies in a hands-on capacity as well as evaluation of analytical data generated at external partners.
• Proficient in writing technical reports and formulating presentations
• Ability to develop cross functional relationships with discovery chemistry and other pre-clinical groups.
• Experience in leading and managing technology transfers to third party process development and manufacturing partners.
• Knowledge of cGMP requirements and ICH guidelines related to CMC small molecule drug-substance development and manufacturing.
• Track record of working closely with cross-functional teams in a biopharmaceutical or pharmaceutical environment.
• Excellent interpersonal and communication skills.