Senior Scientist, Drug Product Development

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Senior Scientist, Drug Product Development will lead formulation and drug product (DP) development for our ADC pipeline. This individual will play a key role in establishing internal lab capabilities, executing formulation studies, developing lyophilization cycles, and partnering cross-functionally within CMC and Clinical teams. The ideal candidate will thrive in a fast-paced, startup environment and be comfortable balancing strategic planning with hands-on laboratory execution.

Responsibilities

• Lead formulation development for antibody and ADC drug products, including stability-indicating formulation screening and optimization for early and late stage products.


• Design, develop (internally and/or externally), and tech-transfer drug product processes including lyophilization, for ADC drug products to ensure manufacturability, and scalability.


• Support building internal formulation lab capabilities, including equipment selection.


• Serve as the internal subject matter expert (SME) for DP formulation and lyophilization, guiding both internal scientists, as the team expands, and external CDMOs.


• Collaborate closely with ADC DS Development, Analytical Development, QC and QA teams to ensure end-to-end alignment across CMC.


• Author and review CMC documentation, including development reports, regulatory submissions (IND/IMPD/BLA), and technical transfer packages.


• Evaluate and implement emerging technologies for ADC formulation and lyophilization to drive innovation and efficiency.


• Mentor and develop junior scientists as the team expands.

Qualifications

• A minimum of a of industry experience in biologics or ADC formulation and lyophilized drug product development.


• Proven expertise in lyophilization cycle development, characterization, and scale-up for biologics.


• Experience with ADCs and establishing internal lab is preferred.


• Strong hands-on experience in formulation screening, stability studies, and analytical data interpretation.


• Demonstrated experience establishing or operating in an internal lab environment.


• Excellent understanding of CMC principles and regulatory expectations for biologic and ADC drug products associated to the products’ phase.

Knowledge and Skills

• Deep understanding of formulation principles for biologics and ADCs, including critical quality attributes (CQAs), thermal stability and compatibility considerations.


• Proficiency in fill/finish and lyophilization process development, scale-up, optimization, tech-transfer and troubleshooting.


• Strong analytical skills for interpreting data from formulation and stability studies.


• Working knowledge of regulatory requirements for clinical and commercialization of sterile drug products, including application of Quality by Design principles


• Excellent communication and collaboration skills to work cross-functionally and with external partners.


• Ability to innovate and implement emerging technologies in drug product development.


• Ability to manage multiple projects with tight deadlines and priorities.


• Leadership skills to mentor junior scientists and/or manage projects effectively.

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).