Immunome, Inc.
Principal Scientist, Purification Process Development
Bothell, Washington, United States · Principal
Sponsorship not specified$180k-$200kDetected 34 days ago
ComplianceGMPFDA RegulatoryLeadershipCommunication
About the role
- Washington State Pay Range $180,000 - $200,000 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.
Responsibilities
- Oversee Purification Process Development strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for critical process parameters.
- Collaborate with external CDMO partners to support the Immunome pipeline 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.
- Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners.
Requirements
- A Bachelor's, Master's, 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 Masters, or 10 years with a Bachelors, with a primary focus on purification process development, or equivalent experience.
- Prior experience with tech transfer, external CDMO engagement, and internal coordination with relevant functions.
- Prior knowledge of/experience working with GMP manufacturers and processes, including familiarity with regulatory submissions.
- Knowledge and Skills
- A strong understanding of the common purification, analytical, and characterization approaches used for mAbs, with a solid foundation in overcoming some of the challenges encountered in these workflows.
- Must be a purification subject matter expert including chromatography separations and filtration operations (depth, dead-end, virus and ultrafiltration/diafiltration).
- 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, responding to information requests, and interfacing with health authorities.
- 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 while being able to prioritize and balance hands-on tasks with strategic responsibilities.
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 purification processes for antibody intermediates (mAbs).
- The ideal candidate will have experience with technology transfer, regulatory compliance, and coordination with CDMO partners at GMP manufacturing facilities.
Compensation
- Washington State Pay Range
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