Atsena Therapeutics
Research Associate II, Downstream Process Development
Atsena Therapeutics, Durham, North Carolina, United States, 27703
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 are at the cutting edge of ocular gene therapeutics, bringing therapies to the clinic with excellence, integrity, and urgency. Our lead programs include gene therapies for Leber congenital amaurosis (LCA1) and X-linked retinoschisis (XLRS), currently in Phase 1/2 trials, with additional preclinical programs advancing for other inherited retinal diseases. Position Summary: We seek a motivated self-starter at the Research Associate II level to join the CMC – Process Development team. This lab-based role focuses on vector purification and the development and optimization of downstream vector purification unit operations. The successful candidate will work under the guidance of the process development team to perform purification methods in accordance with standard laboratory practices, company policies, documentation, and biosafety policies. This position is expected to spend ~80-90% of effort in the laboratory. Responsibilities
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 Document all lab work accurately and up to date in an electronic lab notebook (ELN) system Prepare buffers and other reagents as needed for experiments Conduct 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 Qualifications
Bachelor’s degree with 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 Experience with ELN and relevant lab equipment software (e.g., Unicorn, ChromLab) Proficiency in Excel and other data-centric software Preferred Qualifications
Knowledge of cGMPs, USP, ICH, and other guidance documents governing Process Development activities Basic understanding of statistical analyses of large datasets, including software such as Prism, JMP, or Design Expert Location
Durham, NC Employment type
Full-time Seniority level
Associate Job function
Science Industries
Biotechnology
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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 are at the cutting edge of ocular gene therapeutics, bringing therapies to the clinic with excellence, integrity, and urgency. Our lead programs include gene therapies for Leber congenital amaurosis (LCA1) and X-linked retinoschisis (XLRS), currently in Phase 1/2 trials, with additional preclinical programs advancing for other inherited retinal diseases. Position Summary: We seek a motivated self-starter at the Research Associate II level to join the CMC – Process Development team. This lab-based role focuses on vector purification and the development and optimization of downstream vector purification unit operations. The successful candidate will work under the guidance of the process development team to perform purification methods in accordance with standard laboratory practices, company policies, documentation, and biosafety policies. This position is expected to spend ~80-90% of effort in the laboratory. Responsibilities
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 Document all lab work accurately and up to date in an electronic lab notebook (ELN) system Prepare buffers and other reagents as needed for experiments Conduct 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 Qualifications
Bachelor’s degree with 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 Experience with ELN and relevant lab equipment software (e.g., Unicorn, ChromLab) Proficiency in Excel and other data-centric software Preferred Qualifications
Knowledge of cGMPs, USP, ICH, and other guidance documents governing Process Development activities Basic understanding of statistical analyses of large datasets, including software such as Prism, JMP, or Design Expert Location
Durham, NC Employment type
Full-time Seniority level
Associate Job function
Science Industries
Biotechnology
#J-18808-Ljbffr