Senior Manager/Associate Director, MSAT/Process Characterization and Validation Readiness (AAV)

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.