Posted 6 days ago

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

New York, New YorkHybridFull-time

AI Summary

Leads AAV process characterization, technology transfer, control strategy development, and PPQ readiness for Sf9/baculovirus and HEK platforms; partners with CMC and CDMO teams to ensure late-stage manufacturing robustness and validation readiness.

About this role

Role Summary

The Senior Manager/Associate Director, MSAT/Process Characterization and Validation Readiness will lead AAV process characterization, technology transfer, control strategy development, and PPQ readiness activities across Sf9/baculovirus and HEK-based manufacturing platforms. This role will partner closely with internal CMC functions and CDMOs to ensure late-stage manufacturing processes are robust, well characterized, and ready for clinical and commercial execution.

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.

Skills

AAVBaculovirusBLACMCControl StrategyCPVDOEFMEAHEKPAIPPQProcess CharacterizationRisk AssessmentSf9Stage 1 Process DesignStage 2 Process QualificationTechnology TransferTroubleshootingValidation Readiness

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

About this role

Primary Responsibilities

Required Skills & Qualifications

Skills

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