Associate Scientist- Biological Sciences in King of Prussia, PA
                                Job title: Associate Scientist- Biological Sciences in King of Prussia, PA at GlaxoSmithKline
Company: GlaxoSmithKline
Job description: The Senior 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.The key responsibilities of the role include the following:
      
      
      
      
Expected salary:
Location: King of Prussia, PA
Job date: Wed, 30 Apr 2025 04:01:09 GMT
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                        Company: GlaxoSmithKline
Job description: The Senior 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.The key responsibilities of the role include the following:
- 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
 - 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
 - Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee’s time depending on production campaigns
 - Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently
 - Performs cleaning/sanitization of equipment and associated parts utilizing equipment washers, Clean-In-Place (CIP) systems as well as manual cleaning methods
 - Prepares, assembles and sterilizes via autoclave of equipment and process components
 - Prepares buffers, including weigh and dispense, formulation, and filtration activities
 - In addition to manufacturing responsibilities, works on projects and assignments where independent action and a high degree of initiative are required in order to resolve problems and make recommendations
 
- 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
 - Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to take action to solve or prevent problems
 - Represent the group during cross-functional initiatives
 - Serve as Subject Matter Expert (SME)
 - Train and mentor less experienced manufacturing scientists
 - 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), Safety Assessments, and various other protocols with minimal supervision
 - Reviews and approves executed documentation, Buffer Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
 - Leads deviation investigations and implementation of CAPAs stemming from Safety or Compliance observations
 - Identifies process improvement opportunities with impact on safety, compliance, and efficiency/cost
 
- Bachelor’s degree Chemical Engineering, Biology, Chemistry, or other engineering or scientific field OR 2-4 years of equivalent experience.
 - Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary
 
- Experience in a Good Manufacturing Practices (GMP) environment
 - Large-scale downstream manufacturing experience
 - 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
 - Demonstrates good interpersonal skills, and communicates well both verbally and through written communications. Maintains a professional and productive relationship with area management and co-workers
 - Ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
 
Expected salary:
Location: King of Prussia, PA
Job date: Wed, 30 Apr 2025 04:01:09 GMT
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