Process and Product Science, Senior Analyst

Takeda • Round Lake, IL

1d • Onsite

About The Position

The Process and Product Science, Senior Analyst manages and performs scientific research, development, and testing of new products, manufacturing processes, and raw materials, and provides technical support to Manufacturing Science at the Round Lake site. The role supports deviations and CAPAs, yield and process improvement, process-data analysis, basic laboratory analyses including microscopy, and the authorship and execution of technical protocols. It applies scientific methods and data-driven analysis to promote efficient, high-quality manufacturing processes and products.

The Senior Analyst collaborates with Manufacturing, Quality, Engineering, and Technical Services to investigate and resolve process issues and implement improvements. The position requires applying GMP and quality-system practices, scientific and engineering principles, and technical documentation skills, with guidance in developing areas such as investigations, experimental design, laboratory analysis, biotechnology, and downstream processing.

Requirements

• Bachelor’s degree in Chemical Engineering, Biological Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific or engineering discipline.
• At least 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.
• Ability to carry, lift, push, and pull up to 70 pounds, using material-handling equipment and/or two-person lifts as needed.
• Ability to stand and/or walk for extended periods during an 8–12-hour shift, including walking between rooms and throughout the plant.
• Ability to perform tasks that may require bending, twisting, reaching overhead, or squatting.
• Ability to work in a cold, wet environment and around chemicals such as alcohol, acids, buffers, and Celite; respiratory protection may be required.
• Ability to work indoors around loud noises, moving equipment, and machinery, and to use hearing protection when required.
• Ability to follow manufacturing-environment restrictions on makeup, jewelry, nail polish, and artificial fingernails.
• Ability to work in controlled environments and follow applicable gowning and protective-clothing requirements; some roles may involve confined spaces, clean rooms, or cool/hot storage conditions.
• Ability to work multiple shifts, including off shifts, weekends, and holidays, as needed to support a 24/7 manufacturing operation, and to work overtime as required.

Nice To Haves

• Experience working cross-functionally with Manufacturing, Quality, Engineering, Technical Services, or Regulatory.

Responsibilities

• Provide deviation and CAPA support, including authoring and reviewing investigation reports, root-cause analyses, and CAPA plans in accordance with GMP and site procedures.
• Serve as a technical and scientific subject matter expert 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 make manufacturing processes more efficient, robust, and streamlined.
• Collect, trend, and analyze process data to understand process performance and variability and develop 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 with Manufacturing, Quality, Engineering, and Technical Services to implement improvements and resolve process issues.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior