Customer Relations, Data Quality, Documentation, Experiment Design, GMP (Good Manufacturing Practices), Identify Issues, Injections, Inventory Management, Manufacturing, Organizational Skills, Performance Management, Performance Tuning/Optimization, Problem Solving Skills, Process Development, Process Improvement, Product Testing, Quality Assurance, Quality Control, Regulatory Requirements, Research & Development (R&D), Scalable System Development, Standard Operating Procedures (SOP), Viruses
PURPOSE OF JOB
Serving as a project leader in Downstream Process Development, the Staff Scientist will collaborate on and drive the planning, execution, and management of assigned purification activities. Working with external clients, R&D, Quality Control/Quality Assurance and Manufacturing, the Staff Scientist is expected to provide expertise and scientific knowledge for design, development, optimization, and manufacturing of protein and virus products. The incumbent will participate in downstream experiment design and execute the downstream process screening, optimization, scale-up, characterization, and stability studies for proteins and viral vectors to meet client specified end points.
The incumbent in this position is expected to have a strong understanding of the principals involved in protein and viral vector purification and extensive hands-on experience in downstream process development. This position involves developing scalable downstream purification processes for GMP production, optimizing process performance for yield and purity, and adapting existing procedures to meet regulatory requirements for the manufacture of protein and viral products intended for human injection. The successful candidate is expected to carry out the work with minimal guidance. This position is expected to interact with other departments involved in technology transfer, GMP manufacturing, product testing and quality assurance for product release.
ESSENTIAL JOB FUNCTIONS
- This is a hands-on laboratory role requiring active participation in experimental execution and process development activities.
- Perform downstream process development studies and generate high-quality data under minimal supervision.
- Service as a downstream technical expert for client projects.
- Generate, manage, and maintain critical data in a highly organized manner in the form of notebook, protocol and SOP.
- Generate, interpret, and document experimental results in the form of technical reports, study summaries, and client-facing documentation.
- Responsible for laboratory maintenance, material ordering, inventory control, and preparation of experiments.
- Stay current with scientific and technical literature and leverage emerging knowledge to solve complex technical problems and improve process performance.
- Formulate and establish process design and performance objectives in consultation with other functions, including Research and Manufacturing, as well as contractors, suppliers, and customers.
- Provide expertise and troubleshooting for all in-house developed processes.
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Advanced BioScience Laboratories Inc