Job Description
Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry. Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support. Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls. Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems. Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization. Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions. Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services. Strong technical writing, communication, presentation, and project management skills. Abi...