Director/Senior Director, Analytical Development And Quality Control

Role Summary

Reporting to the Executive Director of Analytical Development and Quality, the Director of Analytical Development and 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 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.

Location

Lexeo Office. New York, NY

Primary Responsibilities

• Management of Lexeo responsibilities in collaboration with Quality Assurance to establish, maintain, and improve Lexeo’s cGMP compliance and documentation and oversees the effective utilization of the Quality Management System 
• 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 
• 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
• Identification and selection of contract testing organizations for performing development as well as product release testing
• Responsibility 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
• 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
• 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
• Development  and validation of phase-appropriate bio-analytical assays – including qPCR bio-distribution/ vector shedding in different matrices, immunogenicity, and other bio-marker assays specific for cardiac and CNS based AAV gene therapies 

Required Skills & Qualifications

• BS with 15+ 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

Depending on qualifications and overall experience, base salary is likely to be $175,000-$240,000 per year.

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

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