The Engineer or Scientist 2, Material Science supports the design of new single-use consumables in conjunction with our manufacturing teams. This role assists the leachable and extractables program, that includes facilitation of testing based on products evaluated. This role also supports manufacturing investigations involving material science (e.g., raw material variability and concerns, consumable issues and particle sources). The role writes investigation reports and leachable and extractable reports. Job Description What You’ll Do Supports the team with the introduction of new raw materials, and associated document requirements Assesses vendor change notifications, and provides input on raw materials related matters Supports change requests for introduction, modification, and discontinuation of raw materials Provides support between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions) Support troubleshooting, process impact assessments, and facilitation of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects Supports process sub-teams throughout the phases of technology transfer (TT) Supports TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes) Provides comprehensive written manufacturing reports summarizing investigations, studies and projects Supports generation of sampling plans for process validation reports (PVRs) and investigations Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes Assists continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams to improve manufacturability, reliability, yield and cost Assists in solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectives Other duties, as assigned