Principal Scientist, Upstream Process Development

Immunome, Inc. • Bothell, WA

1d

About The Position

We are seeking an experienced and motivated Principal Scientist to join the Upstream Process Development function and support our growing ADC pipeline. This role will be responsible for being the lead on upstream development projects for antibody intermediates (mAbs). The preferred candidate will plan and execute strategies for cell culture process development including leading screening and pilot scale runs to enable material generation. The ideal candidate will have experience with executing bioreactor experiments including high throughput systems like the ambr250, technology transfer and coordination with CDMO partners. A strong working knowledge of key process parameters, scale-up strategies and upstream CMC deliverables is essential, as is experience working with CDMOs to support key milestones in upstream process development.

Requirements

• A Bachelor’s, Master’s, or Ph.D. degree in Chemistry, Biology, 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 upstream cell process development
• Extensive hands-on experience leading and managing automated and bench scale bioreactor experiments. Additionally, prior pilot scale bioreactor, up to 250 L, experience is preferred
• Demonstrated success in optimizing and scaling up upstream processes for monoclonal antibodies and recombinant proteins in a phase appropriate manner
• Prior experience with tech transfer, external CDMO engagement to drive alignment, and internal coordination with relevant functions.
• Prior experience working with GMP manufacturers and processes, including familiarity with regulatory submissions and responding to information requests.
• Subject Matter Expert in upstream development with a strong understanding of mammalian cell culture processes including the ability to troubleshoot and develop process to product understanding
• Ability to statistically analyze data including the incorporation of these concepts into the planning, design, execution and analysis of complex Design of Experiments (DOE)
• The ability to manage multiple projects with CDMOs simultaneously while being able to prioritize and balance strategic responsibilities.
• Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners
• Scientifically curious, with the ability to analyze cell culture data to inform process development decisions and publish/present novel findings in suitable forums

Nice To Haves

• Late stage and BLA experience is preferred.

Responsibilities

• Implement and execute Upstream Process Development strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for process optimization.
• Fulfill the role of a cell culture 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 to support tech transfers, GMP activities, and regulatory submissions for clinical development and commercialization.
• Stay current with emerging trends, innovations, and regulatory requirements, integrating necessary or potentially beneficial features into our internal company strategies and workflows.
• Collaborate extensively with internal stakeholders while fostering a high performing team culture with high commitment towards meeting timelines

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree