Senior Scientist-LVV, Process Development

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

• Masters 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.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.