Senior Scientist, Formulation & DP Development (ADCs)

Immunome, Inc.; Bothell (WA); On-site; USD 156,000 - 190,000; Full time

Job summary

Immunome, Inc. in Bothell, WA is seeking a Senior / Principal Scientist to lead formulation and drug product development for our ADC pipeline.

You will drive late-stage development, regulatory submissions, and lifecycle management while delivering robust, commercially viable DP formulations. The role requires deep expertise in biologics and ADCs, experience with lyophilization, process characterization, and cross-functional leadership across Regulatory Affairs, Manufacturing, QA, and Clinical

Qualifications

• PhD/MS/BS in relevant field with biotechnology industry experience.
• Experience leading late-stage development programs (Phase 3, regulatory submission).
• Proven expertise in lyophilized dosage forms and ADC DP development.

Responsibilities

• Lead formulation development for antibody, drug substance, and ADC DP.
• Serve as SME for fill-finish, lyophilization, comparability, and lifecycle management.
• Drive process scale-up and technology transfer to ensure manufacturability.
• Develop NORs, PARs, control strategies and process characterization.
• Collaborate with cross-functional teams for regulatory readiness.
• Author regulatory submission sections (IND, BLA) and tech transfer packages.

Skills

Biologics formulation

ADC development

Lyophilization

Process scale-up

Technology transfer

CMC documentation

Regulatory submissions

QbD

Cross-functional leadership

Mentoring

Education

Ph.D. in Chemistry/Biochemical Engineering/Biotechnology

MS in related field

BS in related field

Job description

Immunome, Inc. in Bothell, WA is seeking a Senior / Principal Scientist to lead formulation and drug product development for our ADC pipeline.

You will drive late-stage development, regulatory submissions, and lifecycle management while delivering robust, commercially viable DP formulations. The role requires deep expertise in biologics and ADCs, experience with lyophilization, process characterization, and cross-functional leadership across Regulatory Affairs, Manufacturing, QA, and Clinical