Scientist I, Global MS&T Capabilities

The Scientist I in Global Manufacturing Sciences & Technology Capabilities will support the Materials Science group in the life cycle management of consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The scientist will serve as the subject matter expert for single-use technologies and consumable material management within the biologics network. The successful candidate will collaborate closely within the Manufacturing Sciences and Technology organization as well as with representatives from Process Development, Global Procurement, Supply Chain, Manufacturing, Manufacturing Technology, Quality Assurance, Analytical Sciences and Global Regulatory Sciences on cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives. Responsibilities: Provide technical expertise for single-use systems implementation including the authorship of qualification and validation technical documentation Support consumable specification development in support of network strategies Evaluate and manage supplier changes to single-use systems (component design, manufacturing process, specification, etc.) to maintain GMP compliance. Perform material testing and assessments to determine suitability of new single-use systems for commercial biologics manufacturing Lead the testing of single-use systems as necessary to qualify use of the new components in GMP manufacturing Lead and assist in material related manufacturing investigations Provides single-use system subject matter expertise for health authority inspections and interactions with regulatory agencies. Requirements: An understanding of industrial single-use technology applications, with a strong background in polymer chemistry/synthesis. Experience in applying, developing, or transferring polymeric characterization methods including but not limited to spectroscopic, physical, and separation techniques Minimum MS or equivalent with minimum of 4-6 years relevant experience, Ph.D. with 0-2 years relevant experience, in the polymer, material sciences, or chemical engineering. Awareness of cGMP compliance and regulatory agency requirements. Proven project management skills, including leading cross functional teams and balancing project assignments. Demonstrated problem solving ability Strong oral communication and technical writing skills R1511897
Salary Range: NA
Minimum Qualification
5 - 7 years

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