Process Science Engineer II (Lab)

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Job Description

Primary Objectives of this Job

• Perform laboratory experiments, use tests or small-scale investigations

• Support or lead small-scale studies and data gathering for manufacturing operations (process investigations, improvement projects)

• Support or lead the evaluation of process improvements and design of small-scale experiments to implement process improvements

• Provide technical support in small scale experiment troubleshooting

Responsibilities

• Plan and execute laboratory experiments according to internal and external guidelines for small scale process development and validation, process investigations and improvements, qualified scale down models and material use tests

• Support analytical activities relevant to laboratory scale experiments. Work with the relevant cross functional or global teams to ensure that the testing support are in place for experiments.

• Design, plan and execute the laboratory experiments according to experimental plan timelines. Plan and execute activities required for laboratory experiments for eg, and not limited to cell culture/ purification/media/buffer preparation

• Create and review of laboratory documentation including procedures, forms, protocols and reports for routine activities and / or experiments according to relevant quality standards

• Analyse and summarize laboratory results. Compile results into laboratory reports. Support equipment troubleshooting in event of failures.

• Perform laboratory equipment maintenance and calibration as per laboratory procedures

• Plan and implement qualified scale down models through executing the experimental runs and drafting required documentation.

• Lead or support troubleshooting for any issues or atypical results from small scale studies

• Support the implementation of new technologies for small scale model development and improvement

• Lead implementation of new equipment in the laboratory.

• Lead 5S/6S activities within the laboratory and execute housekeeping activities within the lab

• Order and stock materials, including consumables and raw materials

• Support EHS audit walkdowns, and close audit CAPAs on time

• Responsibility to adhere to any applicable EHS requirements.

• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.

• Any other duties as assigned by supervisor.

Education and Experience Requirements

• Bachelor’s Degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 4 years of relevant experience or Master’s Degree with 2 years of relevant experience.

• Hands-on experience with cell culture/ upstream processes and/or downstream purification processes in a manufacturing or development / small scale lab environment.

• Has awareness of cGMP knowledge

Key Skills and Competencies

• Strong experience in laboratory operations for biological upstream or downstream processes.

• Strong knowledge in analytical and cell culture/purification laboratory equipment • Good communication skills

• Good stakeholder management and conflict management skills.

• Willingness to learn

• Team worker/ able to work in matrix environment

• Independent worker/ Self starter

• Flexible to be able to work after office hours where required to support laboratory experiments

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