Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jan 23 2025 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 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 This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of the role include the following: Manages daily activities within the production area, including personnel effort Serves as floor lead during preparation and processing activities and potentially as area Supervisor, in the absence of the Supervisor Leads 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 Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to take 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), 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 Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s or Master’s degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field OR 5+ years of equivalent experience Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary Preferred Qualifications: At least 3+ years of direct experience in a Good Manufacturing Practices (GMP) environment Large-scale purification manufacturing experience Experience with GE platform of purification equipment and Unicorn software 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 #GSK-LI Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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