Major responsibilities

• Plan dual-path development strategies for adherent (cell factories/fixed-bed) and suspension (HEK293-based) processes and assess platformization and scale-up pathways.
• Define the relationships between critical quality attributes (CQAs) and critical process parameters (CPPs) to establish the upstream control strategy and design space (proven acceptable ranges, PAR), supporting late-stage regulatory filings.
• Optimize upstream processes (e.g., DNA:PEI ratio, plasmid quantity, cell density, temperature/DO/pH, feeding and medium exchanges, harvest window) and implement robustness-by-design to mitigate inter-batch variability.
• Develop scale-up strategies, execute engineering runs, and support late-clinical/PPQ readiness.
• Transfer the process to internal GMP manufacturing or CDMOs, author process development reports, batch records, SOPs, and risk assessments (FMEA).
• Lead or contribute to quality activities during manufacturing, including deviation investigations, change control, and CAPA (corrective and preventive actions).
• Contribute to drafting and responding to queries for late-stage CMC sections of IND/BLA/IMPD filings related to process and control strategy.
• Serve as the upstream technical representative and collaborate cross-functionally with DSP, Analytical Development (AD), Manufacturing, and QA/RA on program execution.

Education, Qualifications, Skills and Experience

• Master’s degree or above in Bioengineering, Biopharmaceuticals, Cell Biology, Virology, or a related discipline.
• 4+ years of upstream process development experience in gene therapy or viral vectors, with late stage (Phase II/III), PPQ, or commercial support experience.
• Dual-track experience in adherent and suspension process development, has led at least one scale-up and tech transfer project for adherent (cell factories/fixed-bed) and at least one for suspension (HEK293 suspension). Experience with stable packaging cell lines is a plus.
• Hands-on experience with single-use bioreactor platforms (shake flasks/shakers, bioreactors, tubing and bag configurations) and GMP facility operations, with the ability to troubleshoot scale-up issues.
• Proficient in DoE, multivariate analysis, and statistical analysis.
• Excellent English writing and communication skills, clear verbal communication and able to represent Upstream in program meetings.
• Strong project management and cross-functional collaboration skills, able to drive decisions and deliver under time pressure across multiple workstreams.