The Associate Scientist leads the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically, hands-on cGMP mid to large scale purification of bulk drug substance for use in early phase clinical trials.
Key responsibilities include:
• Performs hands-on processing of large scale purification steps under cGMP regulatory conditions. Processing steps include: Column packing, Chromatography, UltraFiltration/DiaFiltration, Depth Filtration, Bulk Drug Fill
• Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee's time depending on production campaigns
• Leads or works on projects and assignments where independent action and a high degree of initiative and knowledge are required for execution or to provide recommendations
• Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently
• Manages daily activities within the area, including personnel efforts
• Serves as floor lead during preparation and processing activities and potentially as area Supervisor, in the absence of the Supervisor
• May be required to perform cleaning/sanitization of equipment and associated parts utilizing equipment washers, Clean-In-Place (CIP) systems as well as manual cleaning methods, on as-needed basis
• May be required to prepares, assembles and sterilizes via autoclave of equipment and process components, on as-needed basis
• May be required to prepare buffers, including weigh and dispense, formulation, and filtration activities, on as-needed basis
Specific Duties include: :
• Executes and overseas production of clinical supplies based on established scientific procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data
• Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to takes action to solve or prevent problems
• Recognizes potential safety and compliance problems and takes action to rectify
• Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and takes action to rectify or communicate to appropriate decision makers
• Authors Standard Operating Procedures (SOPs), Investigation reports, Safety Assessments, and various other protocols with minimal supervision
• Reviews and approves executed load documentation (washer and autoclave), Buffer Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field
• 1+ year(s) of direct GMP manufacturing experience or purification experience
• Thorough knowledge of Good Manufacturing Practices (GMP) regulations
• Thorough knowledge of routine laboratory/plant equipment and demonstrates high level of technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes
• Possess in-depth knowledge of how to analyze and interpret experimental/process data
• Demonstrated ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
• Experience with GE platform of purification equipment and Unicorn software
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
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As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
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