Principal Scientist, Purification Process Development

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.