Senior/Principal Scientist, Analytical Development and QC, Linker Payload

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. 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 targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

We are seeking an experienced Senior or Principal Scientist of Analytical Development and Quality Control to support Linker Payload (LP) development for our Antibody Drug Conjugate (ADC) portfolio. This role will be responsible for overseeing aspects of analytical method development in collaboration with Contract Development and Testing Labs (CDMOs and CTLs). In addition, this role will be part of a team to build and enhance internal analytical development capabilities, including method development, validation, and transfer processes. The ideal candidate will have a proven background in developing complex LP analytical methods spanning characterization and QC testing. Extensive experience in CDMO interactions, and experience in authoring analytical documents for regulatory submissions.

Responsibilities

• In collaboration with Contract Development/Manufacturing Organization (CDMO), develop robust analytical testing methodologies to support complex small molecule manufacturing, characterization, release and stability testing.
• Oversee and manage relationships with external testing labs ensuring alignment with project timelines, quality standards, and regulatory requirements.
• Assume Analytical Lead responsibilities for Immunome pipeline programs, providing scientific guidance on data analysis and interpretation, contributing to the preparation of regulatory submissions and technical reports.
• Participate in the creation of essential documentation (SOPs, protocols, reports) to support GMP activities, regulatory submissions and method transfers.
• Stay informed of emerging trends in analytical development and evolving regulatory requirements, integrating these into the company's development and QC strategy.
• Mentor, coach, and develop scientists and technical staff, fostering a high-performance and collaborative team culture.
• Work closely with cross-functional teams, including discovery and process chemistry, bioanalytical development, and quality assurance, to ensure alignment on project goals and objectives.

Qualifications

• A Bachelors, Masters, or PhD in Analytical Chemistry or a related field.
• A minimum of 5 years of experience performing small molecule analytical method development in an industry capacity.
• Significant experience with highly potent Linker Payloads is required.
• Prior experience managing analytical development with CDMOs, method transfer/qualification, and Quality Control programs is highly preferred.
• Working knowledge of GMPs, experience in regulatory submissions and responding to Information Requests is preferred.

Knowledge and Skills

• Operational and Strategic experience in phase appropriate analytical method development and product characterization, with a thorough understanding of regulatory guidelines (FDA, EMA, etc.)
• Deep expertise in LP product characteristics including understanding of conjugate type and linker-payload properties on product quality.
• Working knowledge in advanced analytical technologies, such as HPLC, UPLC, NMR, and Mass Spectrometry for analysis of Linker Payloads.
• In-depth knowledge of GMP standards and regulatory guidelines, with experience supporting regulatory submission.
• Excellent judgment and the ability to transition seamlessly between hands-on tasks and strategic responsibilities.
• Comfort with ambiguity and complex challenges; adapts quickly and aids teams through dynamic environments.
• Exceptional communication skills with the ability to collaborate effectively across functions.
• Solution-oriented problem-solving skills, with the capacity to manage multiple projects and prioritize in a fast-paced setting.
• Position may require occasional evening and/or weekend commitment.
• Position may require domestic and international travel.

Washington State Pay Range

$144,514-$167,454 USD

E/E/O

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