- Develop and implement assays at contract laboratories
- Oversee technical transfers, validate assays, and conduct QC activities for material release, stability, and comparability
- Compile data sets for Regulatory submissions
- Manage lifecycle of analytical methods supporting clinical products
- Support qualification of Reference standards and Control Materials
- Quality representative for cGMP regulations and manage GxP vendors
- Coordinate with internal and external stakeholders
- Ensure timely development and testing of samples
- Identify and mitigate risks in assay performance
- Develop, review, and approve procedures and specifications
- Provide strategic direction on analytical aspects and best practices
- Expertise in testing methodologies for gene therapy products
- Support in-house analytical development capabilities
- BS with 10+ years, MS with 12+ years, or Ph.D. with 8+ years in relevant fields
- 3-5 years' experience in biotechnology or pharmaceuticals
- Experience in cell and gene therapy products
- Successful drug submissions experience
- Knowledge of FDA, cGMPs, ICH guidelines, and QBD principles
- Strong cross-functional acumen and problem-solving skills
- Bias for action and accountability
- Experience in a small company environment
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Director/Senior Director, Quality Control - New York, United States - Lexeo Therapeutics
Description
Role SummaryReporting to the Executive Director of Analytical Development and Quality, the Director of Quality Control provides leadership of a scientific team responsible for executing the development and management of analytical assays related to AAV-based gene therapy programs. This position also involves managing QC testing and release of GMP materials, as well as overseeing vendors to ensure efficient results and resolving quality issues promptly. The role demands collaboration, multitasking, and a desire to thrive in a dynamic environment. Being part of an early-stage company, this role holds great visibility and impact within the organization.
Location
Our work culture follows a hybrid model with some days in the New York City office and others working from home. We encourage applications from candidates in the Northeast and Mid-Atlantic regions. Exceptional candidates may even be considered for a remote working setup.
Primary Responsibilities
Expected base salary range of $175,000-$240,000 per year.
Lexeo Therapeutics is an EEO employer committed to fostering an inclusive and diverse workplace.
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