Director, Potency Assay Development

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 a highly experienced and motivated individual to lead our Potency Assay Development team as the leader of CMC Potency Assay Development to support our Antibody Drug Conjugate (ADC) portfolio. This role will be responsible for overseeing aspects of potency assay development tin 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 interactions, and experience in authoring analytical documents for regulatory submissions.

Responsibilities

• Build and lead the CMC Potency Assay development team to design and optimize antibody drug conjugate potency control strategies in support of product release, stability and characterization.
• Oversee the development of phase appropriate functional assays in collaboration with external partners, contract testing labs (CTLs), contract development and manufacturing organizations (CDMOs) to support product release and characterization.
• Provide scientific leadership in addressing technical challenges related to potency assay development including identification, procurement and management of critical reagents.
• Collaborate with cross-functional teams, including research, process and formulation development, and quality assurance, to ensure seamless integration of Potency Assay strategies across all phases of development.
• 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.
• Stay current with industry trends, technologies, and regulatory requirements for potency assay development and emerging technologies.
• Manage the preparation of technical reports, documentation, and regulatory submissions to support clinical development and commercialization.
• Stay informed of emerging trends in ADC functional assay 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.

Qualifications

• PhD in Biological Sciences or related field with a focus on mechanism of action (MoA) assay development for Biologics. Antibody drug conjugate experience preferred.
• A minimum of 10 years of relevant experience in the biopharmaceutical industry, specifically in CMC potency assay development.
• Proven track record of leading successful potency assay development for complex biologics from clinical phase to commercialization.

Knowledge and Skills

• Good understanding of ADC specific potency assay challenges, including control of effector function, bystander activity and other relevant MoAs.
• Prior experience overseeing contract testing labs, method transfer/qualification, and Quality Control programs specifically for potency assays.
• Working knowledge of GMPs, experience in regulatory submissions and responding to Information Requests.
• Operational and Strategic experience in phase appropriate potency assay method development and product characterization, with a thorough understanding of regulatory guidelines (FDA, EMA, etc.)
• Good understanding of ADC specific potency assay challenges, including control of effector function, bystander activity and other relevant MoAs.
• Prior experience overseeing contract testing labs, method transfer/qualification, and Quality Control programs specifically for potency assays.
• Working knowledge of GMPs, experience in regulatory submissions and responding to Information Requests.
• Deep expertise in ADC product characteristics including understanding of conjugate type and linker-payload properties on product quality.
• Working knowledge in the full suite of 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.

Washington State Pay Range

$248,131-$281,511 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.