Lexeo Therapeutics

Operations

• 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

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

Compliance

• Provide strategic leadership and operational oversight for the Quality Management System (QMS), Document Control, and Training functions
• Serve as the business owner and subject matter expert for the electronic Quality Management System (eQMS), ensuring system performance, compliance, and continuous improvement
• Lead the development, review, approval, implementation, and lifecycle management of Standard Operating Procedures (SOPs), work instructions, policies, and quality records
• Oversee document control processes, including document issuance, revision control, archival, and periodic review
• Manage GxP and non-GxP training programs, ensuring timely assignment, completion, effectiveness, and compliance with regulatory expectations
• Develop quality metrics and dashboards to monitor system performance and identify opportunities for continuous improvement
• Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, Clinical Development, and other cross-functional teams to ensure quality system effectiveness
• Support internal audits, external audits, regulatory inspections, and supplier audits related to Quality Systems, documentation, and training
• Ensure Quality Systems remain aligned with FDA, EMA, ICH, and applicable global regulatory requirements
• Lead and mentor Quality Systems personnel, fostering a culture of compliance, accountability, and continuous improvement.

Associate Director – Quality Systems and Compliance

Vice President

• Define and lead the global Medical Affairs strategy across Lexeo’s portfolio, ensuring alignment with development milestones and business objectives
• Build, mentor, and lead a high-performing Medical Affairs organization, including external partners and future in-house team members
• Own scientific communications strategy, including publications planning, congress strategy, medical education, and dissemination of clinical and disease-state insights
• Establish and oversee external engagement strategy with key opinion leaders, investigators, medical societies, and patient advocacy organizations
• Serve as the senior Medical Affairs representative in cross-functional governance, partnering with Clinical Development, Regulatory, Market Access, and Patient Advocacy leaders
• Guide medical input into clinical development plans, patient identification strategies, launch readiness planning, and evidence-generation priorities
• Oversee medical review processes and ensure high-quality, compliant externally facing scientific content and response materials
• Lead advisory board strategy and execution, translating stakeholder insights into actionable plans for development and commercialization
• Represent Lexeo externally at major scientific meetings, investigator forums, and executive-level partner interactions
• Drive the development of onboarding, scientific training, and internal medical education initiatives to elevate organizational disease-area expertise
• Lead medical evidence generation and align the same with company objectives

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

Associate Director – Quality Systems and Compliance

Vice President, Medical Affairs