Senior/Principal Scientist, ADC Formulation & DP Development Lead

Immunomeinc; Bothell (WA); On-site; USD 156,000 - 190,000; Full time

Job summary

Immunome, Inc. in Washington state seeks a Senior/Principal Scientist, Formulation and Drug Product Development to lead late-stage DP development for our ADC pipeline, driving regulatory submissions, comparability, and lifecycle management.

You will develop robust liquid and lyophilized formulations, mentor scientists, collaborate across functions, and deliver commercially viable processes from concept to post-approval support.

Qualifications

• Extensive experience in biologics and/or ADC drug product development, including lyophilized dosage forms.
• Demonstrated success leading late-stage development programs through Phase 3, regulatory submission, approval, and/or commercialization.
• Experience establishing NORs, PARs, design spaces, and control strategies to support process validation and commercial manufacturing.
• Hands-on lyophilization cycle development, scale-up, validation support, and technology transfer for biologics.
• Experience authoring and reviewing CMC documentation for INDs, IMPDs, BLAs, and other regulatory submissions.

Responsibilities

• Lead formulation development for antibody, drug substance, and ADC drug products, including 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; drive process scale-up and transfer to ensure manufacturability.
• Lead development of comparability strategies for formulation changes, site transfers, scale-up, and lifecycle management.
• Establish NORs and PARs, control strategies, and process characterization approaches for late-stage and commercial products.
• Collaborate with multiple teams to align development and commercialization activities.
• Prepare and review technical reports, regulatory submission sections, and technology transfer packages.
• Support regulatory interactions related to formulation development and lifecycle management.
• Provide strategic leadership for product lifecycle management initiatives.
• Evaluate emerging technologies to drive innovation and efficiency.
• Mentor junior scientists and contribute to building internal DP capabilities.

Skills

Biologics development

ADC drug product

Late-stage development

CMC submission

Regulatory strategy

Lyophilization expertise

QbD & risk assessment

Technology transfer

Cross-functional leadership

Education

PhD in Chemistry/Biochemical Engineering

MS in related field

BS in relevant field

Job description

Immunome, Inc. in Washington state seeks a Senior/Principal Scientist, Formulation and Drug Product Development to lead late-stage DP development for our ADC pipeline, driving regulatory submissions, comparability, and lifecycle management.

You will develop robust liquid and lyophilized formulations, mentor scientists, collaborate across functions, and deliver commercially viable processes from concept to post-approval support.