Principal Scientist, Purification Process Development
Immunome, Inc.
June 28, 2026
Remote friendly (Bothell, WA)
United States
Operations
Position Overview:
Principal Purification Process Development Scientist to optimize purification processes for antibody intermediates (mAbs), including scale-up to tox/GMP, with expertise in tech transfer, regulatory compliance, and coordination with CDMO partners.
Responsibilities:
- Oversee purification process development using DOE and OFAT for critical process parameters.
- Serve as purification SME on cross-functional CMC teams.
- Collaborate with external CDMO partners across pre-clinical to commercial stages; occasional travel to support development and GMP manufacturing.
- Prepare SOPs, protocols, and reports for tech transfers, GMP activities, and regulatory submissions.
- Monitor emerging trends and regulatory requirements for mAb purification and integrate improvements into internal workflows.
Qualifications:
- BS, MS, or PhD in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or related field.
- Minimum experience: 5+ years biotech/biopharma with PhD; 8+ years with MS; 10+ years with BS, focused on purification process development (or equivalent).
- Experience with tech transfer, CDMO engagement, and internal coordination.
- Experience with GMP manufacturers/processes and regulatory submissions.
- Lead/support authoring and reviewing Module 3 regulatory submissions (IND, IMPD, BLA, etc.).
- Familiarity with laboratory operations and establishing a development lab.
- Proven success developing/optimizing purification for monoclonal antibodies and recombinant proteins.
- Experience with regulatory submissions, responding to information requests, and interfacing with health authorities.
Knowledge/Skills:
- Purification, analytical, and characterization approaches for mAbs; chromatography and filtration (depth, dead-end, virus, UF/DF).
- AKTA chromatographic instrument expertise (Avant/Ready or similar).
- Ability to plan and execute complex experiments using DOE.
- Ability to manage multiple projects and balance hands-on and strategic work.
- Exceptional communication and collaboration skills.
- Tecan high-throughput liquid handling experience is a plus.
Principal Purification Process Development Scientist to optimize purification processes for antibody intermediates (mAbs), including scale-up to tox/GMP, with expertise in tech transfer, regulatory compliance, and coordination with CDMO partners.
Responsibilities:
- Oversee purification process development using DOE and OFAT for critical process parameters.
- Serve as purification SME on cross-functional CMC teams.
- Collaborate with external CDMO partners across pre-clinical to commercial stages; occasional travel to support development and GMP manufacturing.
- Prepare SOPs, protocols, and reports for tech transfers, GMP activities, and regulatory submissions.
- Monitor emerging trends and regulatory requirements for mAb purification and integrate improvements into internal workflows.
Qualifications:
- BS, MS, or PhD in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or related field.
- Minimum experience: 5+ years biotech/biopharma with PhD; 8+ years with MS; 10+ years with BS, focused on purification process development (or equivalent).
- Experience with tech transfer, CDMO engagement, and internal coordination.
- Experience with GMP manufacturers/processes and regulatory submissions.
- Lead/support authoring and reviewing Module 3 regulatory submissions (IND, IMPD, BLA, etc.).
- Familiarity with laboratory operations and establishing a development lab.
- Proven success developing/optimizing purification for monoclonal antibodies and recombinant proteins.
- Experience with regulatory submissions, responding to information requests, and interfacing with health authorities.
Knowledge/Skills:
- Purification, analytical, and characterization approaches for mAbs; chromatography and filtration (depth, dead-end, virus, UF/DF).
- AKTA chromatographic instrument expertise (Avant/Ready or similar).
- Ability to plan and execute complex experiments using DOE.
- Ability to manage multiple projects and balance hands-on and strategic work.
- Exceptional communication and collaboration skills.
- Tecan high-throughput liquid handling experience is a plus.