Neurogene Inc.
Senior Scientist, Upstream Process Development
Neurogene Inc., Houston, Texas, United States, 77246
Senior Scientist, Upstream Process Development
Join to apply for the
Senior Scientist, Upstream Process Development
role at
Neurogene Inc. Location: Houston, TX Overview
The Upstream Process Development group will focus on the planning, execution, and analysis of studies targeted to support Neurogene's viral vector platform. The role will center on supporting late-stage development, process characterization, and leading recombinant AAV vector preparation laboratory work to support preclinical studies, toxicology batches, reference material, and clinical products. Responsibilities include supporting routine cell expansion, cell screening, production of viral vectors in small to mid-scale bioreactors, and filtration. Other duties may include laboratory maintenance, procurement of essential consumables, and cross-collaborative assistance with downstream process development and manufacturing groups. The ideal candidate will have expertise in late-stage upstream process development, process characterization, and recombinant AAV vector preparation at small- to large-scales, including purification, titer assessment, and quality control. Knowledge of regulatory guidelines surrounding cGMP manufacture, and a deep understanding of viral vector bioprocessing, and/or experience with capsid engineering and process development of AAV gene therapy products is preferred. Experience working in AAV gene therapy is required. Responsibilities
Independently perform routine suspension cell culture (sampling, cell counting, passaging) Maintain upstream equipment Support upstream technology strategies in various platforms (shakes flasks, rocker, 2L, 10L, 50L) from development to GMP manufacturing; Lead unit operations for development, toxicology, and GMP batches for viral vector production Ensure adequate inventory of materials and collaborate with supply chain Draft, edit, and review data capture forms, batch production records, SOPs, or standard work for process development equipment and unit operations Maintain laboratory records and data using GDP Collaborate with pre-clinical, analytical development, quality control, and manufacturing on upstream process development project timelines Minimum Requirements
Education: Minimum BSc in Biological Science/ Chemistry/ Chemical Engineering Experience: Expertise in AAV gene therapy; experience with biosafety cabinet operations, cell culture incubators, shaking platforms, centrifugation equipment, aseptic technique, and cleaning procedures Experience with media preparation, monitoring cell culture, routine sampling, and analysis of cell expansion Experience handling various sized shake flasks and small-scale bioreactors in a process development setting Proficiency with MS Office and basic cell kinetic analysis Large-scale bioreactor experience is a plus; AAV bioprocessing and development is a plus; experience with cell line development is a plus; GMP environment experience is a plus Knowledge, Skills & Attributes
Deep understanding of AAV bioprocessing Understanding of late-stage process development Cell kinetics analysis (doubling times, growth curves, viabilities) Pilot-scale filtration experience is a plus Ability to draft and execute SOPs/Standard Work Elements GMP operations understanding is a plus Time-management and forward-thinking Effective oral and written communication Proficiency in MS Office and Excel MFCS/SCADA software experience is a plus Problem solving and critical thinking Interest in PD/GMPW environment focusing on gene therapy viral vector bioprocessing Strong focus on delivering results and meeting metrics Self-starter with energy, initiative, and ability to drive pace Desire to contribute to a growing company with a patient-focused mission Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Biotechnology
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Join to apply for the
Senior Scientist, Upstream Process Development
role at
Neurogene Inc. Location: Houston, TX Overview
The Upstream Process Development group will focus on the planning, execution, and analysis of studies targeted to support Neurogene's viral vector platform. The role will center on supporting late-stage development, process characterization, and leading recombinant AAV vector preparation laboratory work to support preclinical studies, toxicology batches, reference material, and clinical products. Responsibilities include supporting routine cell expansion, cell screening, production of viral vectors in small to mid-scale bioreactors, and filtration. Other duties may include laboratory maintenance, procurement of essential consumables, and cross-collaborative assistance with downstream process development and manufacturing groups. The ideal candidate will have expertise in late-stage upstream process development, process characterization, and recombinant AAV vector preparation at small- to large-scales, including purification, titer assessment, and quality control. Knowledge of regulatory guidelines surrounding cGMP manufacture, and a deep understanding of viral vector bioprocessing, and/or experience with capsid engineering and process development of AAV gene therapy products is preferred. Experience working in AAV gene therapy is required. Responsibilities
Independently perform routine suspension cell culture (sampling, cell counting, passaging) Maintain upstream equipment Support upstream technology strategies in various platforms (shakes flasks, rocker, 2L, 10L, 50L) from development to GMP manufacturing; Lead unit operations for development, toxicology, and GMP batches for viral vector production Ensure adequate inventory of materials and collaborate with supply chain Draft, edit, and review data capture forms, batch production records, SOPs, or standard work for process development equipment and unit operations Maintain laboratory records and data using GDP Collaborate with pre-clinical, analytical development, quality control, and manufacturing on upstream process development project timelines Minimum Requirements
Education: Minimum BSc in Biological Science/ Chemistry/ Chemical Engineering Experience: Expertise in AAV gene therapy; experience with biosafety cabinet operations, cell culture incubators, shaking platforms, centrifugation equipment, aseptic technique, and cleaning procedures Experience with media preparation, monitoring cell culture, routine sampling, and analysis of cell expansion Experience handling various sized shake flasks and small-scale bioreactors in a process development setting Proficiency with MS Office and basic cell kinetic analysis Large-scale bioreactor experience is a plus; AAV bioprocessing and development is a plus; experience with cell line development is a plus; GMP environment experience is a plus Knowledge, Skills & Attributes
Deep understanding of AAV bioprocessing Understanding of late-stage process development Cell kinetics analysis (doubling times, growth curves, viabilities) Pilot-scale filtration experience is a plus Ability to draft and execute SOPs/Standard Work Elements GMP operations understanding is a plus Time-management and forward-thinking Effective oral and written communication Proficiency in MS Office and Excel MFCS/SCADA software experience is a plus Problem solving and critical thinking Interest in PD/GMPW environment focusing on gene therapy viral vector bioprocessing Strong focus on delivering results and meeting metrics Self-starter with energy, initiative, and ability to drive pace Desire to contribute to a growing company with a patient-focused mission Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Biotechnology
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