Principal Scientist, Purification Process Development
Immunome, Inc.
2 months ago
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, and support clinical and commercial-stage manufacturing.
Responsibilities
- Oversee purification process development strategies, including DOE and One Factor at a Time (OFAT) approaches for critical process parameters.
- Serve as a purification subject matter expert (SME) on cross-functional CMC teams.
- Collaborate with external CDMO partners across pre-clinical, clinical, and commercial stages; occasional travel to advise/oversee development and GMP manufacturing.
- Prepare documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions.
- Stay current on purification and regulatory trends for mAbs and integrate beneficial updates into internal strategies.
Qualifications
- Bachelor’s, Master’s, or Ph.D. in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or related field.
- Minimum biotech/biopharma experience: 5+ years (Ph.D.), 8+ (Master’s), or 10+ (Bachelor’s) focused on purification process development.
- Experience with tech transfer, external CDMO engagement, and internal coordination.
- Experience working with GMP manufacturers/processes; familiarity with regulatory submissions.
- Lead/support authoring and reviewing Module 3 regulatory submission sections (IND, IMPD, BLA, etc.).
- Familiar with laboratory operations and establishing a development lab.
- Demonstrated success optimizing purification processes for monoclonal antibodies and recombinant proteins.
- Experience with regulatory submissions, responding to information requests, and interfacing with health authorities.
Knowledge/Skills (Required/Preferred)
- Strong understanding of purification, analytical, and characterization approaches for mAbs.
- Purification SME including chromatography and filtration (depth, dead-end, virus, ultrafiltration/diafiltration).
- Expert user of AKTA chromatographic instruments (e.g., AKTA Avant, AKTA Ready).
- Ability to plan and execute complex experiments and document/present using DOE.
- Manage multiple projects; balance hands-on and strategic responsibilities.
- Exceptional collaboration and communication skills with internal and external partners.
- High-throughput liquid handling systems (Tecan) experience is a plus.
Compensation
- Washington State pay range: $180,000 - $200,000 USD.
Principal Purification Process Development Scientist to optimize purification processes for antibody intermediates (mAbs), including scale-up to tox/GMP, and support clinical and commercial-stage manufacturing.
Responsibilities
- Oversee purification process development strategies, including DOE and One Factor at a Time (OFAT) approaches for critical process parameters.
- Serve as a purification subject matter expert (SME) on cross-functional CMC teams.
- Collaborate with external CDMO partners across pre-clinical, clinical, and commercial stages; occasional travel to advise/oversee development and GMP manufacturing.
- Prepare documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions.
- Stay current on purification and regulatory trends for mAbs and integrate beneficial updates into internal strategies.
Qualifications
- Bachelor’s, Master’s, or Ph.D. in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or related field.
- Minimum biotech/biopharma experience: 5+ years (Ph.D.), 8+ (Master’s), or 10+ (Bachelor’s) focused on purification process development.
- Experience with tech transfer, external CDMO engagement, and internal coordination.
- Experience working with GMP manufacturers/processes; familiarity with regulatory submissions.
- Lead/support authoring and reviewing Module 3 regulatory submission sections (IND, IMPD, BLA, etc.).
- Familiar with laboratory operations and establishing a development lab.
- Demonstrated success optimizing purification processes for monoclonal antibodies and recombinant proteins.
- Experience with regulatory submissions, responding to information requests, and interfacing with health authorities.
Knowledge/Skills (Required/Preferred)
- Strong understanding of purification, analytical, and characterization approaches for mAbs.
- Purification SME including chromatography and filtration (depth, dead-end, virus, ultrafiltration/diafiltration).
- Expert user of AKTA chromatographic instruments (e.g., AKTA Avant, AKTA Ready).
- Ability to plan and execute complex experiments and document/present using DOE.
- Manage multiple projects; balance hands-on and strategic responsibilities.
- Exceptional collaboration and communication skills with internal and external partners.
- High-throughput liquid handling systems (Tecan) experience is a plus.
Compensation
- Washington State pay range: $180,000 - $200,000 USD.