Immunome, Inc.

Immunome, Inc.

Senior / Principal Scientist, ADC Conjugation Process Development

Bothell, Washington, United States · Principal

Sponsorship not specifiedDetected 35 days ago
ComplianceGMPFDA RegulatoryAnimal StudiesLeadership

About the role

  • 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 submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed

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.
  • Fulfill role as ADC DS subject matter expert (SME) on both internal cross-functional CMC teams and for external CDMO partners to ensure alignment on ADC program goals, deliverables, and objectives.
  • Prepare essential documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions for clinical development and commercialization.

Requirements

  • A Bachelors, Masters, or Ph.D. degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
  • A minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 years with a Master's, or 10 years with a Bachelor's degree, or equivalent experience.
  • An ADC or Conjugation/Bioconjugation Process Development focus is required.
  • Expected expertise in relevant laboratory operations and equipment necessary for successful execution of development activities.
  • Prior experience with tech transfer, external CDMO engagement (encompassing both Development and GMP manufacturing activities), and internal coordination with relevant cross-functional teams.
  • 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
  • Lead the multi-gram scale purification optimization for both antibody intermediates and ADCs via ultrafiltration/diafiltration (UF/DF), and, if required, preparative chromatography or other approaches.
  • A minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 years with a Master's, or 10 years with a Bachelor's degree, or equivalent experience. An ADC or Conjugation/Bioconjugation Process Development focus is required.
  • 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. Expected expertise in relevant laboratory operations and equipment necessary for successful execution of development activities.

Nice to have

  • Company Overview
  • Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA
  • IM-1021, a clinical-stage ROR1 ADC
  • IM-3050, an IND-cleared FAP-targeted radiotherapy
  • and IM-1617, an IND-cleared solid tumor ADC.
  • Position Overview
  • This role will be responsible for the optimization of critical conjugation and purification process parameters for ADC Drug Substance (DS) Development.
  • The ideal candidate will have experience with technology transfer, regulatory compliance, and coordination with CDMO partners at GMP manufacturing facilities.
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