Process and Product Science, Senior Analyst

About the role:

As the Process and Product Science, Senior Analyst, you will manage and perform scientific research, development, and testing of new products, manufacturing processes, and raw materials. You will provide technical support to Manufacturing Science at the Round Lake site. Key areas of responsibility include deviation and CAPA support, including authoring records and serving as a subject matter expert for investigations; yield improvement and process improvement projects;

analyzing process data to better understand and streamline manufacturing processes; and performing basic laboratory analyses, including microscopic analysis, and authoring and executing protocols. This role contributes to Takeda's mission by applying rigorous scientific methods and data-driven analysis to help ensure efficient, high-quality manufacturing processes and products.

• Provide deviation and CAPA support, including authoring and reviewing records (e.g., investigation reports, root cause analyses, CAPA plans) in accordance with GMP and site procedures.
• Serve as a technical and scientific subject matter expert (SME) for investigations, evaluating process and product data to determine root cause and assess impact.
• Plan, lead, and execute yield improvement projects, working independently with limited supervision.
• Apply scientific and engineering principles to improve manufacturing processes, making them more efficient, robust, and streamlined.
• Collect, trend, and analyze process data to build a deeper understanding of process performance and variability, and to drive data-based recommendations.
• Perform basic laboratory analyses, including microscopic analysis, to support investigations and process understanding.
• Author, execute, and report on technical protocols and studies, including experimental design and data summaries.
• Partner cross-functionally with Manufacturing, Quality, Engineering, and Technical Services to implement improvements and resolve process issues.
• Developing practical experience with Good Manufacturing Practices and quality systems, can apply basic principles with guidance, including in deviation and CAPA activities.
• Beginning to understand and apply basic chemical engineering concepts and principles in routine situations with guidance.
• Possesses a foundational understanding of biochemistry, able to perform basic tasks with guidance and apply concepts in routine situations.
• Developing practical writing skills with an understanding of basic grammar and punctuation, still requires supervision and feedback when authoring investigation records and protocols.
• Developing practical experience in investigations and root cause analysis, able to provide technical support with guidance.
• Developing practical experience in analyzing process data, able to apply basic data analysis methods under guidance.
• Developing practical experience in innovation and process improvement, with a basic understanding of how to generate or refine ideas to improve yield and efficiency, still requiring ongoing supervision.
• Gaining practical experience in experimental design and protocol execution, can apply basic concepts and methods under continued guidance.
• Developing practical experience in basic laboratory analysis, including microscopic analysis, able to perform routine tasks with supervision.
• Developing practical experience in biotechnology, can perform simple tasks with supervision and understands basic biological processes and their applications.
• Building practical experience in downstream processing, able to assist under close supervision in the retrieval and refinement of valuable substances.

• Bachelor’s degree in Chemical Engineering, Biological Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific or engineering discipline required.
• 5+ years of related experience in pharmaceutical, biotechnology, biologics, medical device, or other regulated manufacturing environments.
• Experience applying scientific and engineering principles to manufacturing processes, product performance, investigations, process improvement, or technical problem solving.
• Working knowledge of GMP regulations, quality systems, and manufacturing process controls.
• Experience analyzing technical data and authoring or contributing to technical reports, protocols, investigations, risk assessments, or other controlled documentation.
• Experience…