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

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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.