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Position Description: Serve as TS/MS Product/Process representative of manufacturing/packaging process teams to provide technical support:
- Responsible for ensuring for its area of expertise that complex process issues are addressed in a structured and resolved manner and, if necessary, scaled to the Secondary Loop.
- Supports product process and sterile manufacturing process related studies and validation activities due to change or project.
**Key Objectives/Deliverables: **
Product Process related：
- Overseeing process capability (process in control and capable) and yield variables, including: Assisting the Process Team with identifying sources of variation (i.e. common or special cause variability) and recommending appropriate improvements; Owning the process mass balance and the potential sources of product losses including waste.
- Understand the Operational Control Strategies and own the process /product related portions of the Control Strategy including how the process parameters and other input variables (e.g. CPP and CIPC) can potentially impact the Critical Quality Attributes (CQA),as well as the historic and potential failure modes for the process and their associated countermeasures (e.g. iMCS).
- Know the product/process control factors, the analytical control strategy and the development and validation history.
- Ensure there is an accurate Process Flow Document (PFD) that describes the process, analytical methods, the control strategy, the Process Parameters, Critical Quality Attributes (CQA)and includes references to supporting data.
- Perform routine process monitoring, appropriate product and process assessment (e.g. end of campaign summaries, Annual Product Reviews, etc.) and re-validation activities as appropriate.
Others：
- Actively present/participate Process Team activities.
- Understand the purpose and science of the process within their scope and have a thorough understanding of the entire process and its associated equipment, facilities, computer systems and operations.
- Owning product/process related deviations, complaints, corrective and preventative actions, and changes. Providing expert process knowledge in all investigations. Ensuring changes to process have no adverse impact on product quality.
- Owning the batch records and revisions and ensuring they remain current and accurate.
- Educating, coaching and providing ongoing reinforcement of Process Team members and frontline staff on the product and process, e.g., Process School.
- Ensuring approved process and sterility assurance related procedures and instructions can be executed as written so that practice matches procedure, e.g. PMX, SOP/WI.
- Participate in the design and execution of process, cleaning, sterility and bioburden control strategies, analytical transfers and validation exercises.
- Serve as the point of contact between the process team and TSMS functional team. Represent key priorities in both teams and ensure alignment or escalate as needed.
- Serving as a liaison to other scientific and/or technical experts outside the process team such as Molecule Stewards, development scientists or others as needed to interpret process control data and resulting implications for process control strategies.
- Communication and collaboration with cross-functional teams, Lilly Global platforms, and SMEs from other Lilly sites.
- Follow various HSE management procedures and fulfil the work safety responsibilities.
- Accept the delegation from supervisor.
- Finish the other duties assigned by supervisor.
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