Senior / Principal Scientist, Formulation and Drug Product Development

The posting, as Immunome, Inc. wrote it

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, 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.

Position Overview

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.

Responsibilities

• 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 improvements 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, Quali

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• Strong understanding of global regulatory expectations for clinical and commercial sterile drug products.
• Expertise evaluating the impact of product and process changes on product quality and developing risk-based comparability strategies.
• Strong analytical and scientific problem-solving skills with the ability to interpret formulation, stability, characterization, and process development data.
• Excellent communication and influencing skills with demonstrated success leading cross-functional teams and interacting with external partners.

Washington State Pay Range
$155,896 — $190,220 USD

Join Our Experienced, Passionate Team

Working at Immunome gives you the opportunity to make a difference in the lives of cancer patients, contribute to developing best-in-class targeted cancer therapies, and work with some of the brightest and most experienced minds in antibody-drug conjugate (ADC) development.

Immunome’s office is charged with the collective excitement and passion of people working together to develop life-changing cancer medicines. Our team thrives in an innovative, collaborative environment where employees are empowered to do their best work.

Immunome also offers a comprehensive benefit program for you and your family, including:

• Medical, dental, and vision insurance coverage for employees and their dependents, including 100% company-paid medical premiums for employees
• A 401(k) with employer match
• Employer-paid life insurance, short- and long-term disability insurance, and AD&D
• Paid time off, company holidays, and a week-long winter break between Christmas and New Years.
• Paid parental leave

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) .