Research Associate II, Downstream Process Development

Overview

Atsena Therapeutics is a clinical-stage gene therapy company leveraging novel AAV capsids for the treatment and prevention of blindness caused by inherited retinal disease. We pride ourselves on being at the cutting edge of ocular gene therapeutics and on bringing them to the clinic with excellence, integrity, and urgency. Our lead programs, gene therapies for Leber congenital amaurosis (LCA1) and X-linked retinoschisis (XLRS), are currently being evaluated in Phase 1/2 clinical trials.

We are also advancing additional preclinical programs to treat other forms of inherited retinal diseases.

Position Summary:

We seek a motivated self-starter at the Research Associate II level to join the CMC – Process Development team at an exciting and successful startup company developing ocular gene therapies. The successful candidate will be responsible for vector purification and the development and optimization of downstream vector purification unit operations. This is a lab-based position that involves employing a variety of purification methods in accordance with standard laboratory practices and company policies, including documentation and biosafety policies.

This position is expected to spend ~80-90% of effort in the laboratory.

• Perform laboratory techniques including preparative chromatography, depth filtration, tangential flow filtration, and ultracentrifugation.
• Follow established procedures to purify rAAV vectors.
• Prepare, execute, and analyze study plans to characterize and optimize downstream unit operations with direction from the process development team.
• Properly document (accurate and up to date) all lab work through an electronic lab notebook (ELN) system.
• Prepare buffers and other reagents as needed for experiments.
• Sample testing and data analysis.
• Comply with standard laboratory practices and company policies, including documentation and biosafety policies.
• Contribute to the overall mission and culture of Atsena Therapeutics.

• Bachelor’s degree and a minimum of 2 to 4 years of related experience; or an advanced degree without experience.
• Prior experience performing FPLC purification of biologics.
• Prior experience in a Process Development laboratory.
• Use of an ELN and relevant lab equipment software (Unicorn, Chrom Lab, etc.).
• Proficiency in Excel and other data-centric software.

• Knowledge of cGMPs, USP, ICH, and other guidance documents controlling Process Development activities.
• Basic understanding of statistical analyses of large datasets, including use of statistical software such as Prism, JMP, or Design Explor.t