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About the Role
Lead AAV process characterization, technology transfer, control strategy development, and PPQ readiness activities across Sf9/baculovirus and HEK-based manufacturing platforms. 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.
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.
Requirements
- Advanced degree in biochemical engineering, bioprocess engineering, molecular biology, cell biology, biotechnology, or related discipline.
- Master’s degree 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
- Process characterization
- Technology transfer
- Control strategy development
- PPQ readiness
- Sf9/baculovirus manufacturing
- HEK-based manufacturing
- Risk-based strategies
- Process robustness evaluation
- Critical process parameters
- Process performance evaluation
- Product quality attributes
- Validation readiness
- Regulatory documentation
- Cross-functional leadership
- Priority management
- Clear communication
- Collaboration with internal teams and CDMOs
- Process optimization
- Scale-up
- Scale-down models
- Upstream AAV manufacturing
- Downstream AAV manufacturing
- Bioreactor operations
- TFF
- Chromatography
- Formulation
- DoE
- Stage 1 Process Design
- Stage 2 Process Qualification
- PPQ
- CPV
- Validation strategy
- BLA/PAI readiness
- Process parameters
- CQAs
- Risk assessments
- Late-stage CMC decision-making
- Technical protocols authoring
- Technical reports authoring
- Regulatory documentation authoring
- Manufacturing support documents authoring
- Technical protocols review
- Technical reports review
- Regulatory documentation review
- Manufacturing support documents review
- Technical troubleshooting
- Continuous improvement
Location
- New York City
Work Type
- Hybrid
Experience Level
- Senior Manager
- Associate Director
Education Level
- Master's degree
- PhD
Salary/Compensations
- $176,000 - $187,000 a year
About the Company
- 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.
Equal Opportunity
- LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.