Scientist, Analytical Development

Role Summary

Reporting to the Senior Director, Analytical Development and Quality, the Scientist provides leadership in the development of analytical assays related to AAV-based gene therapy programs. This includes development of cell based and molecular (e.g. qPCR/ddPCR) assays and establishing the mechanism-of-action of AAVs in cellular systems using novel approaches. This position requires collaborative skills, multi-tasking ability, and desire to strive in a fast-paced environment. We are an early-stage company, so this is a highly visible and impactful role in our organization. 

Location

Lexeo Office located in New York, NY.

Primary Responsibilities

• Development of phase-appropriate testing methodologies – including such assays as digital PCR, potency, quantitative PCR – for AAV gene therapy vectors
• Assist in the development and internal testing of potency assays in a target-specific manner.
• Building in-house capability in analytical development for viral vectors
• Assist in driving the analytical strategy of the organization and support regulatory activities for filing 
• Assist in collaborating with CDMOs and CROs to support production and release of GMP materials 
• Participate in technical transfer between laboratories, qualification/validation of assays and QC activities for material release
• Timely development of assays as well as testing of samples for material release
• Identification and communication of risks in assay performance and their mitigation
• Provide support to the organization regarding analytical aspects, e.g. regulations, compliance and current industry best practices

Required Skills & Qualifications

• BS with 4+ years, MS with 2+ years or Ph.D. in chemistry, biochemistry, life sciences, pharmaceutical sciences, chemical engineering or equivalent
• Experience in cell and gene therapy products.
• Experience with pharmaceutical drug-process validation and manufacture a plus
• Knowledge of FDA, cGMPs, and ICH guidelines and QBD principles a plus
• 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 $110,000-$125,000 per year.

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