Senior/Principal Scientist, Bioconjugation Process 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 an experienced and motivated Senior/Principal Development Scientist to support our growing Antibody Drug Conjugate (ADC) pipeline. This role will be responsible for the optimization of critical conjugation parameters for ADC Process Development. The preferred candidate will execute conjugation strategies from milligram to multi-gram scales while demonstrating a particular expertise in practical, robust purification strategies applicable to clinical and commercial-stage manufacturing of ADC Drug Substance (DS). The ideal candidate will have experience with technology transfer, regulatory compliance, and coordination with CDMO partners at GMP manufacturing facilities. A strong working knowledge of different conjugation technologies and cytotoxic linker-payloads is essential, as is experience with standard analytical and characterization approaches used for both biologics and ADCs.

Responsibilities

• Implement and execute ADC Conjugation Process Development (PD) strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for critical reaction parameters.
• Oversee the progression of ADC batch sizes from milligram to >100 g scales to support not only PD optimization, but analytical and formulation development, DS/DP stability studies, and in vivo experiments (including critical GLP tox studies) for both IND- and BLA-stage activities.
• Lead the multi-gram scale purification optimization for both antibody intermediates and ADCs via ultrafiltration/diafiltration (UF/DF), and, if required, preparative chromatography.
• Fulfill role as DS subject matter expert (SME) on cross-functional CMC teams to ensure alignment on ADC program goals, deliverables, and objectives.
• Collaborate with external CDMO partners to support ADC DS pipeline development from pre-clinical, through clinical and commercial stages. Occasional travel to advise and oversee Development and GMP manufacturing processes will be expected.
• Prepare essential documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions for clinical development and commercialization.
• Stay current with emerging trends, innovations, and regulatory requirements for ADC Drug Substance, integrating necessary or potentially beneficial features into our internal company strategies and workflows.
• Mentor, develop, and manage a team of scientists and technical personnel, fostering both a high-performing team culture and individual professional growth.
  
  

Qualifications

• A Bachelors, Masters, or PhD degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
• A minimum of 5 years of biopharma industry experience with a PhD, 8 with a Master’s, or 10 with a Bachelor’s industry dedicated to bioconjugation process development up to at least multi-gram scale. An ADC focus is preferred.
• Demonstrated success with the Development and scale-up of different ADC conjugation technologies and strategies, including a proven ability to work with a variety of different small molecule linker-payloads and antibody intermediate materials.
• Prior experience with tech transfer, external CDMO engagement, and internal cross-functional coordination with antibody, chemistry, analytical, and related teams at the discovery research and development stages.
• Prior experience working with GMP manufacturers and processes, including familiarity with regulatory submissions and responding to information requests.
  
  

Knowledge And Skills

• A strong understanding of the common conjugation, purification, analytical, and characterization approaches used for ADCs, with a solid foundation in overcoming some of the challenges encountered in these workflows.
• Expertise in tangential flow filtration (TFF) at the multi-gram scale for the efficient removal of unreacted linker-payloads and to provide a stable ADC DS formulation.
• Good working knowledge of standard analytical and characterization techniques used for ADCs including, but not limited to, SEC, HIC, IEX, and RP U/HPLC chromatographic methods in addition to LC-MS strategies for biomolecules and related conjugates.
• Knowledge of GMP standards and regulatory guidelines, with experience supporting IND and BLA submissions.
• The ability to manage multiple projects simultaneously while being able to prioritize and balance hands-on tasks with strategic responsibilities.
• Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners.
• Strong leadership and people management skills, fostering a high-performance, collaborative team culture within a dynamic and fast-paced environment.
  
  

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.