Scientist, Process Development

• Design and execute process development experimental plans, author associated protocols and reports, and present data and insights to cross-functional teams
• Develop phase-appropriate cell therapy manufacturing processes using Quality by Design (QbD) principles
• Support technology transfer of processes to CDMOs for early-phase cGMP clinical manufacturing, as needed
• Contribute to the development of platform manufacturing processes and ensure readiness for clinical and future commercial manufacturing
• Identify and evaluate opportunities to improve manufacturing performance, including cost, throughput, robustness, and quality
• Maintain laboratory materials and sample inventory to support experimental planning and execution
• Accurately document experimental data in a timely manner, ensuring data integrity, traceability, and compliance with protocols
• Maintain individual training requirements in a compliant state
• Contribute to regulatory filings (e.g., IND/CTA) and technical documentation, as needed
• Other related duties, as assigned

• Bachelor’s Degree with 4+ years of experience, or Master’s Degree with 2+ years of experience, within biologics process development and manufacturing under cGMP processes
• Experience with cell therapy manufacturing scale-up, technology transfer, and process development methods is required
• Experience with basic biological laboratory techniques such as cell culture, PCR, cell-based bioassays, and/or ELISA
• Extensive experience in flow cytometry and cell-based assays is required
• Strong problem-solving skills are preferred
• Experience supporting regulatory documentation, including but not limited to INDs, CTAs, and BLAs
• Previous experience and working knowledge of T-cells or immunological cell therapies
• Good working knowledge of cGMP manufacturing for biological processes and ICH regulations
• Highly organized and efficient, with a curiosity for cutting-edge science
• Strong team orientation and a passion for continuous self-development
• Ability to coordinate parallel tasks across multiple projects, demonstrating strong prioritization skills

Strong problem-solving skills are preferred

• health and retirement
• PTO
• stock option plans