Primary Responsibilities

Lead risk-based process characterization strategies and studies for AAV manufacturing processes using Sf9/baculovirus and HEK-based platforms
Evaluate process robustness, critical process parameters, process performance, and product quality attributes to support control strategy development
Translate development, engineering, and manufacturing data into technical conclusions that support validation readiness, PPQ planning, and regulatory documentation
Partner with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and CDMO teams to align study design, execution, documentation, and deliverables
Support technology transfer, manufacturing readiness, FMEA activities, comparability assessments, and process validation planning
Author and review protocols, reports, technical summaries, regulatory sections, batch record inputs, and manufacturing support documents
Lead technical troubleshooting and continuous improvement activities as appropriate

Required Skills & Qualifications

Advanced degree in biochemical engineering, bioprocess engineering, molecular biology, cell biology, biotechnology, or related discipline; Master’s with a minimum of 7 years relevant experience or PhD with a minimum of 5 years relevant experience
Experience in viral vector, gene therapy, biologics, or advanced therapy process development required; AAV experience strongly preferred
Demonstrated experience with process characterization, process optimization, scale-up, scale-down models, technology transfer, and validation-readiness activities
Working knowledge of upstream and/or downstream AAV manufacturing processes, including Sf9/baculovirus, HEK-based production, bioreactor operations, TFF, chromatography, or formulation preferred
Understanding of DoE, Stage 1 Process Design, Stage 2 Process Qualification, PPQ, CPV, validation strategy, and BLA/PAI readiness preferred
Strong understanding of process parameters, CQAs, control strategy development, risk assessments, and late-stage CMC decision-making
Experience authoring and reviewing technical protocols, reports, regulatory documentation, and manufacturing support documents
Demonstrated ability to lead cross-functional work, manage priorities, communicate clearly, and collaborate effectively with internal teams and CDMOs.