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Job Description

About the Role:

As a QC Analytical Scientist, you will support multiple Quality Control activities within the AQC department. Main responsibilities are to transfer and implement analytical methods. These methods include raw materials, which are used in a CGMP environment in Quality control. Specifically, they involve both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

How you will contribute:

• Guide special projects that require AQC attention/leadership.
• Improve analytical method development and validation of laboratory methodologies and instrumentation.
• Support investigations and manufacturing investigations requiring analytical method support.
• Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
• Serve on project teams, which will require substantial interaction and communication with other group functions.
• Upgrading of analytical technologies within an established licensed technology platform.
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols
• Support troubleshooting of analytical methods and instruments and support laboratory investigations to provide scientific justification for Out of Specification (OOS), Out of Trend (OOT), and atypical result investigations
• Create laboratory investigations, deviations, CAPAs, and periodic reviews, and other documentation that requires advanced analytical knowledge.
• Ensure all laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation and other technical documents. This includes supporting raw material qualification for new products
• Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.
• Help analyze QC data using statistical tools to identify trends and set limits for results, including data transcription/entry
• Use sound scientific principles and statistical techniques and make recommendations.
• Responsible for deliverables to ensure timelines and milestones are met.
• Support scheduling of AQC and QCM testing (release, execution of protocols).
• May lead small teams to accomplish tasks.
• Ensure Right First Time (RFT) in the method introduction and instrument qualification process.

What you bring to Takeda:

• Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent is ideal.
• Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Write technical documents and reports that meet company and regulatory requirements
• Knowledge of analytical methods and operations with emphasis in problem-solving.
• Knowledge about analytical method validation and critical reagent qualification.
• Intermediate statistical knowledge and experience with data analysis.
• Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
• Basic knowledge about regulatory requirements concerning analytical instrumentation, test methods and licenses
• Substantial understanding concerning regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH
• Complete tasks with minimal direction, demonstration of basic project management skills.
• Ability to multi‐task in a highly dynamic and diverse environment.
• Attention to detail, able to meet deadlines.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• Normal office and laboratory environment.
• May need to work in controlled or clean room environments requiring special gowning.
• May work around chemicals such as alcohol, acids,