Process and Product Science, Senior Analyst Round Lake Beach, IL Category: Manufacturing Sciences

Job description

Find jobs for Location Radius Process and Product Science, Senior Analyst Round Lake Beach, Illinois Apply Now Job ID R0193695 Category Manufacturing Sciences Subcategory Manufacturing & Supply Business Unit Plasma-Derived Therapies Job Type Full time By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Title: Process and Product Science, Senior Analyst Location: Libertyville, IL 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. How will you contribute: 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. What you bring to Takeda: 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 working cross-functionally with functions such as Manufacturing, Quality, Engineering, Technical Services, or Regulatory preferred. Physical Demands Must be able to carry up to 70lbs, lift up to 70lbs, push/pull up to 70lbs, with assistance of material handling equipment and/or two-person lifts. Must be able to stand and/or walk for an extended period over an 8-12 hour shift between rooms and across the site. Must be able to walk within and between quality rooms and packaging rooms, as well as throughout the entire plant. May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks. Work in a cold, wet environment. Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection. Indoor working conditions and exposure to loud noises that requires hearing protection Will work around moving equipment and machinery. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment. Work in a controlled environment requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body (Applies to roles in Filling Department only). May be required to work in confined spaces/areas. Some Clean Room and/or cool/hot storage conditions. (Applies to roles in Filling Department only). May be exposed to and must not be allergic to cephalosporin. (Applies only to product touch roles). May require immunization before performing work within the manufacturing area. Must be able to work on multiple shifts, including weekends, to support a 24/7 manufacturing operation as needed. Must be able to work non-traditional work hours, including weekends and holidays, as needed. Requires flexibility to work during off shift hours and/or conduct activities in support of different shifts as needed. Must be able to work overtime as required. Working Environment Work in a cold, wet environment. Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection. Indoor working conditions and exposure to loud noises that requires hearing protection Will work around moving equipment and machinery. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment. Work in a controlled environment requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body (Applies to roles in Filling Department only). May be required to work in confined spaces/areas. Some Clean Room and/or cool/hot storage conditions. (Applies to roles in Filling Department only). May be exposed to and must not be allergic to cephalosporin. (Applies only to product touch roles). May req