Job Description:

Role SummaryReporting 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 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.LocationOur work culture 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. A remote working model may be considered for exceptional candidates.Primary ResponsibilitiesResponsible for the development and implementation of assays at contract laboratoriesOversight of technical transfer between laboratories, phase-appropriate validation of assays and QC activities for material release, stability and comparabilityCompile 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 testingLEXEO Quality representative with regards to cGMP regulations for manufacturing and testing including deviationOOS investigation, product impact assessments, change management, and other Quality documentation to address non-conformances at external GxP vendorsSupport Gxp vendor management through LEXEO's vendor qualification procedures in collaboration with Quality Assurance and conduct routine audits of GxP vendorsCoordination with internal and external stakeholders, including Process Development, External Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, Clinical Supply, Clinical Operations, and Program managementManage timely development of assays as well as testing of samples for material releaseIdentification and communication of risks in assay performance and their mitigationResponsibility to develop, author, review, andor approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as neededProvide strategic direction to the organization regarding analytical aspects, e.g. regulations, compliance and current industry best practicesProvide 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 materialsSupporting in-house capability in analytical development for characterization of viral vectors, drug substances, and starting materialsRequired Skills & QualificationsBS with 10+ years, MS with 12+ years or Ph.D. with 8+ years in chemistry, biochemistry, life sciences, pharmaceutical sciences, chemical engineering or equivalentAt least 3-5 years of experience in a biotechnology or pharmaceutical companyExperience in cell and gene therapy productsExperience with successful drug submissions IND, BLA, etc.Experience with pharmaceutical drug-process validation and manufactureStrong 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 problemsResults oriented, has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completionAccustomed to "roll up their sleeves" and execute the tasks needed in a small company environmentAnticipated Salary RangeDepending 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.