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

Lexeo Therapeutics

Senior Manager/Associate Director leading AAV process characterization at Lexeo Therapeutics. Overseeing technology transfer and manufacturing readiness for gene therapy candidates.

Posted 7/13/2026full-timeNew York City • New York • 🇺🇸 United StatesSenior💰 $176,000 - $187,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in AAV manufacturing processes, including process characterization, optimization, and validation readiness. Proficient in cross-functional collaboration and technical documentation to support regulatory compliance and product quality.

Highest-signal resume keywords

AAV Manufacturing ProcessesProcess CharacterizationRegulatory DocumentationTechnical TroubleshootingCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process OptimizationScale-Up ModelsTechnology TransferValidation ReadinessBioreactor OperationsChromatographyFormulationDoEControl Strategy DevelopmentRisk Assessments

Soft Skills

Clear CommunicationEffective CollaborationPriority Management

Industry Keywords

Viral VectorGene TherapyBiologicsAdvanced Therapy Process DevelopmentPPQCPVBLA/PAI ReadinessCritical Quality AttributesLate-Stage CMC Decision-MakingFMEA Activities

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Lexeo Therapeutics Website LinkedIn All Job Openings 11 - 50 employees 💰 Corporate Round on 2023-08 Based in New York City, Lexeo Therapeutics is a clinical-stage genetic medicines company dedicated to transforming healthcare by applying pioneering science to fundamentally change how disease is treated. Building on groundbreaking research from Weill Cornell Medicine and the University of California San Diego, Lexeo partners with preeminent institutions on the cutting edge of gene therapy research. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4 associated Alzheimer's disease programs, and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing and commercialization. Senior Manager/Associate Director, MSAT, Process Characterization and Validation Readiness, AAV 🔥 3 hours ago 🏢🏡 New York City – Hybrid 💵 $176k - $187k / year ⏰ Full Time 🟠 Senior ⚙️ Operations 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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 🎯 Requirements
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
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