Senior Scientist-LVV, Process Development Full-time

Job Title

Plan dual-path development strategies for adherent and suspension processes and assess platformization and scale-up pathways.

Define the relationships between critical quality attributes and critical process parameters to establish the upstream control strategy and design space, supporting late-stage regulatory filings.

Optimize upstream processes 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.

Lead or contribute to quality activities during manufacturing, including deviation investigations, change control, and CAPA.

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, 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, 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 and at least one for suspension. Experience with stable packaging cell lines is a plus.

Hands-on experience with single-use bioreactor platforms 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.