BS degree in Chemistry, Biochemistry, chemical engineering or similar with minimum of 5 years of relevant experience. Experience in pharmaceutical or drug combination products. Communicates effectively and concisely pack up information to deliver key points; appropriately scales communication style and depth according to the audience. Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing. Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors. Ability to work independently and collaborate with project teams; organized and self-driven. Strong knowledge of FDA 21 CFR 820 and CFR 210/211. Ability to work in a matrixed environment. Travel up to 10% of the time. Experience in global supplier management, ISO 13485, ISO 9001 strongly desired. Experience with manufacturing support or process development. Experience with project management. Ideally someone with experience in aseptic processes.
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