Director/Senior Director, Quality Control

Reporting to the Executive Director of Analytical Development and Quality, the Director of Quality Control provides leadership of a scientific team that will execute the development and management of analytical assays related to AAV-based gene therapy programs. This role will also manage the QC testing and release of GMP materials and the oversight of vendors necessary to ensure rapid and efficient turnaround of results or resolving of Quality-related issues. This position requires collaborative skills, multi-tasking ability, and a desire to strive in a fast-paced environment. As we are an early-stage company, this is a highly visible and impactful role in our organization.

Primary Responsibilities

• Responsible for the development and implementation of assays at contract laboratories
• Oversight of technical transfer between laboratories, phase-appropriate validation of assays and QC activities for material release, stability and comparability
• Compile data sets (release and stability, analytical validation) for Regulatory submissions.
• Monitors and manages the life cycle of assigned analytical methods supporting clinical products including oversight of stability programs and reference standards.
• Support characterization and qualification of Reference standards and Control Materials used for all analytical testing
• LEXEO Quality representative with regards to cGMP regulations for manufacturing and testing including deviation/OOS investigation, product impact assessments, change management, and other Quality documentation to address non-conformances at external GxP vendors
• Support Gxp vendor management through LEXEO’s vendor qualification procedures in collaboration with Quality Assurance and conduct routine audits of GxP vendors
• Coordination with internal and external stakeholders, including Process Development, External Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, Clinical Supply, Clinical Operations, and Program management
• Manage timely development of assays as well as testing of samples for material release
• Identification and communication of risks in assay performance and their mitigation
• Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
• Provide strategic direction to the organization regarding analytical aspects, e.g. regulations, compliance and current industry best practices
• Provide expertise regarding the development of phase-appropriate testing methodologies to assess strength, potency, impurities, and safety– including such assays for as digital PCR, potency, quantitative PCR, in– for AAV gene therapy vectors, drug substances, and starting materials
• Supporting in-house capability in analytical development for characterization of viral vectors, drug substances, and starting materials

Required Skills & Qualifications

• BS with 10+ years, MS with 12+ years or Ph.D. with 8+ years in chemistry, biochemistry, life sciences, pharmaceutical sciences, chemical engineering or equivalent
• At least 3-5 years of experience in a biotechnology or pharmaceutical company
• Experience in cell and gene therapy products
• Experience with successful drug submissions IND, BLA, etc.
• Experience with pharmaceutical drug-process validation and manufacture
• Strong knowledge of FDA, cGMPs, and ICH guidelines and QBD principles pertaining to analytical development, method validation, technology transfer and quality control testing.
• Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity. Results oriented with breadth and depth in pharmaceutical development and commercial products to resolve complex problems
• Results oriented, has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion
• Accustomed to “roll up their sleeves” and execute the tasks needed in a small company environment

About Lexeo
Lexeo Therapeutics is a New York City-based, clinical-stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. 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.
Our work culture is for most roles is a hybrid model with days in the New York City office and days working from home.  We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.
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