Senior/Principal Scientist Analytical Development and QC, Biologics

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/Principal Scientist of Analytical Development and Quality Control to support our Antibody Drug Conjugate (ADC) portfolio. This role will be responsible for overseeing aspects of physicochemical analytical method development in collaboration with Contract Development and Testing Labs (CDMOs and CTLs). In addition, this role will be key in leading efforts 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 physicochemical ADC analytical methodologies spanning characterization and QC testing. Extensive experience in CTL/CDMO interactions, and experience in authoring analytical documents for regulatory submissions.

Responsibilities

• In collaboration with Contract Testing Labs (CTLs) develop robust analytical testing methodologies to support complex biomolecule 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 the 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, formulation development, and quality assurance, to ensure alignment on project goals and objectives.
  
  

Qualifications

• A Bachelor’s, Master’s, or PhD in Analytical Chemistry, Biochemistry, or a related field.
• A minimum of 5 years of industry experience w physicochemical analytical method development combined with significant experience with Antibody Drug Conjugates.
• Prior experience managing Contract testing labs, method transfer/qualification, and Quality Control programs.
• Working knowledge of GMPs, experience in regulatory submissions and responding to Information Requests.
  
  

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 ADC product characteristics including understanding of conjugate type and linker-payload properties on product quality.
• Working knowledge in advanced analytical technologies, such as Capillary Electrophoresis, Liquid Chromatography, and Mass Spectrometry for analysis of ADCs.
• 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 leads 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 - $172,337 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.