Principal Scientist 35534

Required Skills:

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. Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement. Experience with single-use technologies filling equipment and sterile manufacturing operations is highly desirable

Required Education:

Doctorate (PhD PharmD or MD) with relevant postdoctoral experience where applicable; or Masters degree with 3 years of relevant scientific experience; or Bachelors degree with 5 years of relevant scientific experience. A degree in Mechanical Engineering Chemical Engineering Biomedical Engineering Bioprocess Engineering Pharmaceutical Sciences Biotechnology Biology Microbiology or a related scientific discipline is highly preferred.