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:
- Performs hands-on processing of large-scale purification steps under cGMP regulatory conditions. Processing steps include: reputed company 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-reputed company (CIP) systems as well as reputed company cleaning methods
- Prepares, assembles and sterilizes reputed company 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 reputed company 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 reputed company 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, reputed company 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 reputed company 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