Job: Downstream Process Development Associate/Scientist, StrideBio, Inc, Durham, NC
Downstream Process Development Associate/Scientist
Durham, NC 27709 United States
Title and Compensation commensurate with experience.
Manufacturing and Production
Research and Development
StrideBio, Inc. is seeking a highly self-motivated, talented Associate/Scientist level to join the AAV Process Development team in RTP, NC. The candidate is expected to have a strong scientific background in performing a variety of downstream unit operations as well as excellent oral and written communication skills. This successful candidate will play a key role in the downstream purification of recombinant adeno-associated virus (rAAV) vectors to support research, preclinical studies, and gene therapy clinical trials.
The incumbent will utilize homogenization, micro and ultrafiltration, centrifugation, column chromatography (affinity, ion exchange, size exclusion, etc.) and other methods for the purification of rAAV viral vectors. Work activities will also include preparing protocols, SOPs and final study reports related to production documentation and process development work with minimal supervision. They may also provide assistance in the production of both preclinical and cGMP materials. It is expected that the incumbent will work independently while accomplishing the timely completion of assignments and necessary resolution of unexpected technical issues. The candidate is expected to multitask in the daily execution of these activities. The position will need a person who can work independently and who will be able to effectively carry out complicated procedures and complete all documentation associated with the purification steps. The associate/scientist will work to meet production goals, notify management of any potential delays in the schedule, and make recommendations to resolve the issues.
Duties and responsibilities:
• Design, development, optimization of downstream purification technologies related to rAAV purification
• Performance of rAAV manufacturing at the bench and pilot-scale (0.5-500L) using centrifugation, detergent lysis, microfluidization, filtration (depth, hollow fiber, TFF), and FPLC chromatography
• Assist in the production of preclinical and clinical materials in a laboratory or cleanroom settings
• Author method development and characterization reports and SOPs
• Accurate and timely documentation of work in electronic laboratory notebooks
• Interface with other departments (Quality Control, Quality Assurance, Business, etc.) and external partners as necessary.
• B.S. in Biochemistry, Chemistry, Biology or related disciplines with minimum of 2 years post degree experience in industrial process development lab
• Experience with principles and operations of centrifugation, microfiltration, ultrafiltration, cell disruption, membrane filtration at laboratory and pilot scales
• Familiarity with AKTA chromatography systems and Unicorn software, and standard chromatographic methods (IEX, SEC, HIC, and affinity)
• Experienced working with viral vectors or vaccines and performing bioassays is preferred
• Previous experience working in a GLP/cGMP environment is preferred
• The candidate must be a highly motivated and self-driven individual with the ability to work under minimal supervision
• Proficiency with MS Excel, GraphPad Prism, and ELN is essential
• Must have demonstrated experience effectively managing projects and troubleshooting experiments
• Experience with mammalian suspension cell culture is desired
• Strong writing, verbal, and organizational skills are critical
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