Senior Scientist, Sterile Manufacturing Operations

3 days ago


King of Prussia, Pennsylvania, United States GSK Full time
Senior Scientist, Sterile Manufacturing Operations

GSK is seeking a highly skilled Senior Scientist, Sterile Manufacturing Operations to join our team. As a key member of our sterile manufacturing operations team, you will be responsible for the sterile manufacture of clinical and pre-clinical sterile drug product, including planning, coordination, and manufacturing operations.

Key Responsibilities:

  • Ensure all activities are conducted in full compliance with cGMPs, safety regulations, and critical business requirements.
  • Develop into a technical subject matter expert for clinical operation activities as they relate to the UM Sterile Pilot Plant.
  • Independently coordinate the daily activities of the area supporting the manufacture of early phase injectable products to support pre-clinical and clinical needs.
  • Ensure products manufactured are of the highest attainable level of quality and right first time.
  • Engage with Product Teams to resolve product development issues related to aseptic processing technology or sterile manufacturing equipment.

Requirements:

  • Bachelor's Degree in Microbiology / Biology/ Engineering or similar science field.
  • 1+ year experience working with cGMPs and documentation principles for the manufacture of drug product in a highly regulated environment.
  • Experience working with aseptic techniques and sterility assurance in aseptic processing.

Preferred Qualifications:

  • 2+ years experience working in a GMP drug product manufacturing environment.
  • Ability to work in a complex, multi-tasking environment across local and functional boundaries.
  • Knowledge of pharmaceutical pilot plant technical operations.
  • Excellent oral and written communication skills.


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