Global Capabilities MS&T Materials Scientist

Description: The Scientist I in the Global Drug Substance Materials Science group will support the development of raw material control strategies for the commercial manufacturing of biopharmaceuticals. The scientist will serve as the subject matter expert for raw material characterization and robustness for internal and 3rd party manufacturing sites. 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. The position involves such material management activities as: raw material trending and characterization in relation to process robustness, material specification development, technical material risk assessments, alternate supplier qualifications, supplier change management and regulatory filling support. Responsibilities: Determines critical material attributes for process performance using both traditional and innovative techniques. Provides technical expertise and authorship for: manufacturing investigations, new material implementations, material change controls, technical material risk assessments, and the preparation of regulatory filings in support of commercial manufacturing operations. Implement raw material controls with cross functional partners in Supply Chain, Quality Control and Assurance, Manufacturing, Global Procurement, etc. Demonstrates mastery of SOPs and cGMPs and additional Quality Compliance requirements. Leads cross functional teams for material change management, and process technical transfers. Provides material subject matter expertise for health authority inspections and interactions with regulatory agencies. Requirements: Experience applying, developing or transferring material characterization methods, including but not limited to spectroscopic, physical, and separation techniques. Knowledgeable about sources of variability in biopharma manufacturing operations. Trained in data analysis such as design of experiments or multivariate data analysis. Demonstrated problem solving ability, critical thinking, and communication skills. Awareness of cGMP compliance and regulatory agency requirements. Minimum MS or equivalent with minimum of 4-6 years relevant experience, Ph.D. with 0-2 years relevant experience. Ability to manage multiple project assignments. The position is based at the Bristol-Myers Squibb Devens Facility R1511311
Salary Range: NA
Minimum Qualification
Less than 5 years

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