Senior Principal Scientist, Upstream Process Development

Role Summary

Senior Principal Scientist, Upstream Process Development. Lead a team supporting upstream process development projects, overseeing clone selection, platform fit, process optimization, characterization, scale-up, and tech transfer for clinical manufacturing. Provide support for IND/IMPD and regulatory filings, authoring technical reports, and advancing platform improvement within the upstream workflow.

Responsibilities

• Develop high-performance upstream processes for recombinant protein production (including complex fusion proteins, bispecific antibodies, and antibody-drug conjugates).
• Establish robust upstream process platforms and toolboxes for early-stage programs; collaborate with Cell Line Development (CLD) and Downstream Process Development (DSP) to streamline workflows.
• Lead projects related to continuous improvement or development of new approaches/technologies of strategic importance.
• Apply Quality by Design (QbD) principles in process characterization studies for late-stage programs and jointly develop suitable control strategies for commercial processes.
• Lead pilot-scale runs with single-use bioreactors for scale-up testing and material generation for other functions, including GLP toxicity studies.
• Support tech transfer to internal Clinical manufacturing operations and external CMOs, perform risk assessments, and develop mitigation strategies; provide PIP support and troubleshooting as needed.
• Represent downstream systems in cross-functional CMC teams (including external CMOs) to advance programs toward milestones.
• Evaluate new technologies and external collaborations to improve process understanding.
• Develop IP strategies to ensure freedom to operate and strengthen patent estate.
• Write technical summaries and development reports for knowledge management and regulatory filing support.
• Publish or present scientific findings and contribute to industrial collaborations.
• Provide coaching and feedback to develop team members and colleagues.

Qualifications

• Ph.D. with 6‚Äì8 years, M.S. with 9‚Äì12 years, or B.S. with 12‚Äì15 years of relevant industry experience in Chemical Engineering, Biological Sciences, or related field.

Skills

• Proven track record in design, development, and implementation of industrial cell culture processes for recombinant protein production, including bispecific and fusion proteins.
• Hands-on experience with upstream lab activities and pilot-scale single-use bioreactors; experience with high-throughput mini-bioreactors.
• Knowledge of bioreactor characterization, mass transfer, mixing, shear, and cell metabolism; strong biochemistry knowledge.
• Expertise in cell culture media composition, preparation, analysis, and cell-media interactions; experience with batch, fed-batch, and perfusion.
• Experience with technology transfer to GMP facilities, PIPs, and troubleshooting support.
• Familiarity with PAT, molecular biology, Omics tools, and assays to correlate cell physiology with performance and product quality.
• Familiarity with late-stage process development, process characterization, and control strategies.
• Understanding of CMC timelines and cross-functional collaboration (CLD, DSP, Analytical, Manufacturing, MS&T, Regulatory).
• Ability to evaluate and introduce new technologies to accelerate upstream development and improve efficiency.
• Strong project leadership and resource management; excellent verbal and written communication; adaptable to a fast-paced environment.

Education

• Ph.D. (6‚Äì8 yrs), M.S. (9‚Äì12 yrs), or B.S. (12‚Äì15 yrs) in Chemical Engineering, Biological Sciences, or related field with relevant industry experience.