Senior​/Principal Scientist, Formulation and Drug Product Development

Senior / Principal Scientist, Formulation and Drug Product Development

Bothell, Washington, United States

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, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA;

IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

The Senior / Principal Scientist, Formulation and Drug Product Development will lead formulation and drug product (DP) development activities for Immunome's ADC pipeline, with a strong emphasis on late-stage development, regulatory submissions, process validation readiness, comparability assessments, and product lifecycle management.

This individual will be responsible for developing robust, commercially viable drug product formulations and manufacturing processes for liquid and lyophilized biologics and ADCs. The role will provide technical leadership for formulation development, drug product process development, technology transfer, process characterization, control strategy development, and lifecycle management activities across clinical and commercial programs.

The ideal candidate will possess deep expertise in biologics and ADC drug product development and a demonstrated track record advancing products through Phase 3, BLA submission, commercial launch, and post-approval lifecycle management. This individual will thrive in a fast-paced biotech environment and be comfortable balancing strategic leadership with hands-on scientific execution.

• Lead formulation development for antibody, drug substance, and ADC drug products, including formulation screening, optimization, stability characterization, and development of commercial-ready formulations.
• Serve as SME for formulation and drug product process development—including fill-finish, lyophilization, characterization, comparability, and lifecycle management; driving process scale-up and transfer to ensure manufacturability, robustness, and commercial readiness.
• Lead formulation and drug product comparability strategies and assessments associated with formulation changes, manufacturing process changes, site transfers, scale-up activities, raw material changes, and post-approval improvement plans.
• Establish and justify normal operating ranges (NORs), proven acceptable ranges (PARs), control strategies, and process characterization approaches for late-stage and commercial products.
• Collaborate closely with Drug Substance Development, Analytical Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and Clinical teams to ensure alignment across product development and commercialization activities.
• Author and review technical reports, comparability assessments, risk assessments, control strategy documents, development reports, regulatory submission sections (IND, IMPD, BLA, sBLA), and technology transfer packages.
• Support regulatory interactions and responses related to formulation development, process development, comparability, process validation, and lifecycle management activities.
• Provide strategic leadership for product lifecycle management initiatives, including process improvements, manufacturing investigations, post-approval…