Immunome, Inc.
oncology
PrincipalScientist,PurificationProcessDevelopment
Neural analysis suggests this role is
optimal for Principal candidates.
“Principal Scientist, Purification Process Development at Immunome, Inc.. Skills: Purification Process Development, Monoclonal Antibody Purification, Chromatography, Filtration, Scale-up, GMP Manufacturing, Regulatory Submissions, CDMO Management. Oversee Purification Process Development strategies. Optimization of purification processes for antibody intermediates (mAbs)”
What You'll Achieve.
Ensure alignment on program goals, deliverables, and objectives
Industry & Context.
Overcoming some of the challenges encountered in these workflows
Occasional travel to advise and oversee development and GMP manufacturing processes will be expected
What They're Looking For.
Must Have
Bachelor’s, Master’s, or Ph. D. degree in Chemistry, Chemical Engineering, Biotechnology, or a related field, A minimum of 5 years of biopharmaceutical industry experience with a Ph. D., 8 years with Masters, 10 years with Bachelors, Primary focus on purification process development, Prior experience with tech transfer, Prior experience with external CDMO engagement, Prior experience with internal coordination with relevant functions, Prior knowledge of/experience working with GMP manufacturers and processes, Familiarity with regulatory submissions, Lead/support authoring and reviewing of relevant module 3 sections of regulatory submissions (IND, IMPD, BLA, etc), Familiar with laboratory operations and needs for establishing a highly functioning development lab, Demonstrated success in developing and optimizing purification processes for monoclonal antibodies and recombinant proteins, Experience in regulatory submissions, Experience responding to information requests, Experience interfacing with health authorities, Knowledge and Skills: A understanding of the common purification, analytical, and characterization approaches used for mAbs, Solid foundation in overcoming some of the challenges encountered in these workflows, Must be a purification subject matter expert, Chromatography separations, Filtration operations (depth, dead-end, virus and ultrafiltration/diafiltration), Expert user of AKTA chromatographic instruments (such as AKTA Avant, AKTA Ready or similar), Design, plan, schedule, organize, prioritize, execute, document and present complex experiments using Design of Experiment (DOE) when needed, The ability to manage multiple projects simultaneously, Ability to prioritize and balance hands-on tasks with strategic responsibilities, Exceptional communication skills, Effective collaborations with both internal stakeholders and external partners
Nice to Have
High-throughput liquid handling systems (Tecan) experience is a plus
What You'll Do.
Oversee Purification Process Development strategies
Optimization of purification processes for antibody intermediates (mAbs)
Coordinate and/or execute purification strategies
robust purification strategies applicable to clinical and commercial-stage manufacturing of mAbs
Support the Immunome pipeline from pre-clinical
through clinical and commercial stages
Prepare essential documentation (SOPs
Stay current with emerging trends
and regulatory requirements for mAb purification processes
Integrate necessary or potentially beneficial features into internal company strategies and workflows
How You'll Work.
Team & Collaboration
Fulfill the role of a purification subject matter expert (SME) on cross-functional CMC teams; Ensure alignment on program goals, deliverables, and objectives; Collaborate with external CDMO partners; Coordination with relevant functions; Effective collaborations with both internal stakeholders and external partners
Communication Scope
Exceptional communication skills; Effective collaborations with both internal stakeholders and external partners
Process & Methodology
Manage multiple projects simultaneously, Prioritize and balance hands-on tasks with strategic responsibilities, Design, plan, schedule, organize, prioritize, execute, document and present complex experiments
Full Job Description
Company Overview 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 solid tumor targets. Position Overview We are seeking an experienced and motivated Principal Purification Process Development Scientist to support our growing ADC pipeline. This role will be responsible for the optimization of purification processes for antibody intermediates (mAbs). The preferred candidate will coordinate and/or execute purification strategies including scale-up to tox/GMP, while demonstrating expertise in practical, robust purification strategies applicable to clinical and commercial-stage manufacturing of mAbs. 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 purification technologies is essential, as is experience with standard analytical and characterization approaches used for biologics. Responsibilities Oversee Purification Process Development strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for critical process parameters. Fulfill the role of a purification subject matter expert (SME) on cross-functional CMC teams to ensure alignment on program goals, deliverables, and objectives. Collaborate with external CDMO partners to support the Immu
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