Associate Director, CMC Planning + Operations
Lexeo Therapeutics, New York, NY, United States
Role Summary
Lexeo Therapeutics is seeking a highly motivated and experienced CMC Project and Operations Contractor to join our Technical Operations team. This role will support the Chemistry, Manufacturing, and Controls (CMC) functions by organizing activities, driving strategic initiatives and facilitating operational excellence in support of Lexeo’s gene therapy portfolio. The contractor will collaborate within CMC functions to ensure successful execution and timely completion of CMC deliverables, compliance with regulatory requirements, and alignment with organizational goals. Primary Responsibilities
CMC Strategic Planning: Develop and implement CMC strategies to support preclinical product development, clinical trial material manufacture and supply, late-stage development, validation, BLA preparation, launch activities and commercialization. For both pre-clinical and clinical stage projects provide expert guidance on CMC program timelines, risk management, and resource allocation. Harness the strengths of functional areas, establish a cohesive integrated development strategy, set clear team goals Project Management: Lead and manage CMC workstreams, including tracking of milestones, coordinating cross-functional teams, and ensuring timely completion of deliverables. Preparation and execution of comprehensive Project and Development plans and associated documents for each project ensuring the requirements for all relevant areas are achieved. Lead project team meetings. Maintain CMC RAID, “Risks, Actions, Issues, and Decisions” log, project plans and dashboards. Operational Excellence: Optimize CMC processes and workflows to improve efficiency, quality, and compliance. Identify and address operational bottlenecks, implement best practices, and facilitate continuous improvement initiatives. Regulatory Support: Collaborate with Regulatory Affairs to prepare CMC sections of regulatory filings (INDs, CTAs, BLAs). Ensure documentation meets global regulatory standards and supports successful submissions. Vendor and Partner Management: Support relationships with CDMOs, contract testing laboratories and other external partners. Ensure clear communication of requirements, monitor performance, and facilitate resolution of issues. Incorporate third party timelines into Lexeo Tech Ops integrated project plans Budget and Resource Coordination: Support budgeting, forecasting, and resource planning for CMC activities. Track expenditures and provide status updates to Technical Operations leadership. Reporting and Communication: Prepare and present project updates, dashboards, and reports for internal and external stakeholders. Support the communication of CMC strategy and progress effectively across teams. Required Skills & Qualifications
Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; advanced degree preferred. Minimum of 8 years’ experience in CMC operations, strategy, or project management within the biotechnology or pharmaceutical industry. Proven track record in managing CMC initiatives for clinical-stage or commercial products. Strong understanding of gene therapy, biologics, or advanced therapies manufacturing and regulatory requirements. Exceptional organizational, communication, and analytical skills. Excellent leadership, emotional intelligence, and communication skills Ability to work independently and in a fast-paced, dynamic environment. Experience with external vendor management and cross-functional collaboration. About Lexeo
LEXEO Therapeutics is a New York City-based, clinical-stage gene therapy company focused on addressing some of the most devastating genetically defined cardiovascular and central nervous system diseases affecting both larger-rare and prevalent patient populations. LEXEO’s foundational science stems from partnerships and exclusive licenses with leading academic laboratories at Weill Cornell Medicine and the University of California, San Diego. LEXEO is advancing a deep and diverse pipeline of AAV-based gene therapy candidates in rare cardiovascular diseases and APOE4-associated Alzheimer’s disease and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing, and commercialization Our work culture is a hybrid model with 2 days/week in the New York City office and days working from home. Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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Lexeo Therapeutics is seeking a highly motivated and experienced CMC Project and Operations Contractor to join our Technical Operations team. This role will support the Chemistry, Manufacturing, and Controls (CMC) functions by organizing activities, driving strategic initiatives and facilitating operational excellence in support of Lexeo’s gene therapy portfolio. The contractor will collaborate within CMC functions to ensure successful execution and timely completion of CMC deliverables, compliance with regulatory requirements, and alignment with organizational goals. Primary Responsibilities
CMC Strategic Planning: Develop and implement CMC strategies to support preclinical product development, clinical trial material manufacture and supply, late-stage development, validation, BLA preparation, launch activities and commercialization. For both pre-clinical and clinical stage projects provide expert guidance on CMC program timelines, risk management, and resource allocation. Harness the strengths of functional areas, establish a cohesive integrated development strategy, set clear team goals Project Management: Lead and manage CMC workstreams, including tracking of milestones, coordinating cross-functional teams, and ensuring timely completion of deliverables. Preparation and execution of comprehensive Project and Development plans and associated documents for each project ensuring the requirements for all relevant areas are achieved. Lead project team meetings. Maintain CMC RAID, “Risks, Actions, Issues, and Decisions” log, project plans and dashboards. Operational Excellence: Optimize CMC processes and workflows to improve efficiency, quality, and compliance. Identify and address operational bottlenecks, implement best practices, and facilitate continuous improvement initiatives. Regulatory Support: Collaborate with Regulatory Affairs to prepare CMC sections of regulatory filings (INDs, CTAs, BLAs). Ensure documentation meets global regulatory standards and supports successful submissions. Vendor and Partner Management: Support relationships with CDMOs, contract testing laboratories and other external partners. Ensure clear communication of requirements, monitor performance, and facilitate resolution of issues. Incorporate third party timelines into Lexeo Tech Ops integrated project plans Budget and Resource Coordination: Support budgeting, forecasting, and resource planning for CMC activities. Track expenditures and provide status updates to Technical Operations leadership. Reporting and Communication: Prepare and present project updates, dashboards, and reports for internal and external stakeholders. Support the communication of CMC strategy and progress effectively across teams. Required Skills & Qualifications
Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; advanced degree preferred. Minimum of 8 years’ experience in CMC operations, strategy, or project management within the biotechnology or pharmaceutical industry. Proven track record in managing CMC initiatives for clinical-stage or commercial products. Strong understanding of gene therapy, biologics, or advanced therapies manufacturing and regulatory requirements. Exceptional organizational, communication, and analytical skills. Excellent leadership, emotional intelligence, and communication skills Ability to work independently and in a fast-paced, dynamic environment. Experience with external vendor management and cross-functional collaboration. About Lexeo
LEXEO Therapeutics is a New York City-based, clinical-stage gene therapy company focused on addressing some of the most devastating genetically defined cardiovascular and central nervous system diseases affecting both larger-rare and prevalent patient populations. LEXEO’s foundational science stems from partnerships and exclusive licenses with leading academic laboratories at Weill Cornell Medicine and the University of California, San Diego. LEXEO is advancing a deep and diverse pipeline of AAV-based gene therapy candidates in rare cardiovascular diseases and APOE4-associated Alzheimer’s disease and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing, and commercialization Our work culture is a hybrid model with 2 days/week in the New York City office and days working from home. Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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