Desired Education and Skills:

• Advanced degree in Engineering or Life/Pharmaceutical Sciences.
• 9+ years of upstream process development and MSAT experience in mammalian cell culture, bioreactor, and harvest operations is required.
• Demonstrated understanding of regulatory and cGMP requirements
• Experience with risk assessments, technology transfer, and commercial manufacturing operations.
• Knowledge of regulatory, validation, and documentation requirements for product development, commercial production, and site transfer.
• Strong skills in data trending and analysis using statistical software.
• Strong collaborative and communication skills, and the ability to work well in a cross-functional, matrixed environment are essential.
• Ability to prioritize and perform multiple tasks.