Process and Product Science, Senior Analyst

Takeda•Round Lake, IL

2d•$89,900 - $141,240

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. The role provides technical support to Manufacturing Science at the Round Lake site and applies rigorous scientific methods and data-driven analysis to support efficient, high-quality manufacturing processes and products. The position supports deviations and CAPAs, including authoring and reviewing records and serving as a subject matter expert for investigations. It also leads yield and process improvement work, analyzes process data, performs basic laboratory analyses including microscopic analysis, and authors and executes technical protocols and studies. The role partners with Manufacturing, Quality, Engineering, and Technical Services to resolve process issues and implement improvements. Work may involve multiple shifts and non-traditional hours, including weekends and holidays, as needed, to support a 24/7 manufacturing operation.

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 work on multiple shifts, including weekends, and non-traditional hours as needed.
Ability to work overtime as required.
Ability to carry, lift, push, and pull up to 70 pounds with material-handling equipment and/or two-person lifts.
Ability to stand and/or walk for extended periods over an 8–12-hour shift and to perform tasks involving walking, bending, twisting, reaching overhead, and/or squatting.
Ability to work in environments involving chemicals, loud noises, moving equipment, confined areas, and controlled manufacturing conditions requiring safety gear or gowning, as applicable.

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 improve manufacturing processes and make them more efficient, robust, and streamlined.
Collect, trend, and analyze process data to understand process performance and variability and 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.
Support technical problem solving and manufacturing process, product, and raw-material research, development, and testing.
Work across shifts and support off-shift activities, weekends, holidays, or overtime as needed for manufacturing operations.