Senior Manager/Associate Director, MSAT/Process Characterization and Validation Readiness (AAV) chez Lexeotx · New York, New York

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Lieu de travailHybride

LieuNew York, New York

Bureaux New York, New York

ÉquipeCMC

PubliéJul 10, 2026 · mis à jour il y a 2 sem.

À propos de ce poste Senior Manager/Associate Director, MSAT/Process Characterization and Validation Readiness (AAV) chez Lexeotx

Lexeotx · Hybride · New York, New York

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.

About LEXEO

Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact. 

Our work culture is a hybrid model with 2 days in the New York City office and 3 days working from home.

LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.

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À propos de ce poste Senior Manager/Associate Director, MSAT/Process Characterization and Validation Readiness (AAV) chez Lexeotx

Primary Responsibilities

Required Skills & Qualifications

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