Ts/Ms -Scientist

4 days ago

Cork, Cork, Ireland Claran Consultants Ltd Full time

The TSMS Buffer Representative - Scientist will be responsible for providing technical support for buffer in the operations/manufacturing environment.
The successful candidate will be required to provide technical expertise in the area of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities.
They will also work to ensure the process is in-control, capable, compliant and maintained in a validated state through continual monitoring.
Also supporting the day to day operations of the buffer area to ensure that issues are resolved and maintain supply of process solutions to the respective upstream and downstream areas.
Key Responsibilities: Understand the purpose and science of the process; have an in-depth knowledge of the science (including analytical) behind the molecule and the process.
Expert in buffer operations.
Understand the process control strategy for the biotech products.
Perform data analysis and process monitoring, and be able to assess whether process is in control and capable of meeting its stated purpose and is in a constant state of validation Understand and ensure compliance with regulatory expectations Have a working knowledge of the manufacturing equipment set and control system Understand historic and potential failure modes for the process and equipment Document and communicate work and learnings Leverage internal and external expertise to improve existing production processes Work in a cross-functional team with members of QA, QCL, TSMS Lab, Ops, H&S, Warehouse and bring the deep technical expertise to the team.
Establish partnership with operations to understand interface between the science/engineering with the operations on the floor.
Provide technical support during regulatory audits.
Provide technical expertise during RCA for process deviations/changes.
Identify and implement process improvements.
Attributes for the Role: Demonstrated technical capability with high productivity Proven track record of curiosity with learning agility Demonstrated excellent problem-solving skills Self-starter with high initiative and data-driven approach to problem-solving Demonstrated ability to participate in and facilitate decision-making Demonstrated strong interpersonal skills with demonstrated adaptability and flexibility to working in different environments, teams etc.
Demonstrated strong verbal and written communication skills Educational/Experience Requirements: BSc/MSc in Chemistry, Microbiology, Biotechnology, Biochemistry, Cell Culture or related discipline).
Work Environment: The role is an 8-hr day position, but as a manufacturing support role, the need for occasional evening or weekend support can arise.
Skills: Cell culture Biochem buffer prep analytical science manufacturing support

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