Principal Scientist, Purification Process Development at Immunome, Inc.

Bothell, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

211200.0

Posted On

13 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Purification Process Development, Scale-Up, Technology Transfer, Regulatory Compliance, CDMO Coordination, mAb Purification, Design Of Experiment, OFAT, Chromatography Separations, Filtration Operations, AKTA Instruments, SOP Preparation, Analytical Characterization, GMP Manufacturing, CMC Teams, Data Analysis

Industry

Biotechnology Research

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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. 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 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. Stay current with emerging trends, innovations, and regulatory requirements for mAb purification processes, integrating necessary or potentially beneficial features into our internal company strategies and workflows. Qualifications 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 with Masters or 10 with Bachelors with a primary focus on purification process development. 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. 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. 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). 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. Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners. High-throughput liquid handling systems (Tecan) experience is a plus. Washington State Pay Range $173,777—$211,200 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. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

Responsibilities

This role is responsible for overseeing purification process development strategies for antibody intermediates, including optimization using DOE and OFAT approaches for critical process parameters. The scientist will act as a purification subject matter expert on cross-functional CMC teams and collaborate with external CDMO partners through pre-clinical, clinical, and commercial stages.