Process and Product Science, Senior Analyst

Takeda Pharmaceutical Company Limited; Round Lake (IL); Sur place; USD 90 000 - 141 000; Plein temps

Résumé du poste

Takeda Pharmaceutical Company Limited in Libertyville, IL is seeking a Process and Product Science, Senior Analyst to support deviations, CAPA, and process improvements at the Round Lake site. You will analyze data, perform experiments, and collaborate with Manufacturing, Quality, and Engineering to drive efficiency.

The role requires a chemical engineering or related scientific degree and 5+ years in regulated manufacturing, with a strong emphasis on data‑driven problem solving and technical

Qualifications

• Bachelor's degree in a related scientific or engineering discipline.
• 5+ years of experience in regulated pharmaceutical manufacturing environments.
• Experience applying engineering principles to manufacturing processes and investigations.
• Working knowledge of GMP regulations, quality systems, and process controls.
• Experience writing technical reports, protocols, investigations, or risk assessments.
• Cross‑functional collaboration with Manufacturing, Quality, Engineering, or Technical Services is preferred.

Responsabilités

• Provide deviation and CAPA support, including authoring and reviewing records and root cause analyses.
• Serve as SME for investigations, evaluating data to determine root cause and impact.
• Plan, lead, and execute yield and process improvement projects with limited supervision.
• Apply engineering principles to improve manufacturing processes for efficiency and robustness.
• Collect, trend, and analyze process data to drive data‑based recommendations.
• Perform basic laboratory analyses to support investigations and process understanding.
• Author, execute, and report on technical protocols and studies with proper documentation.
• Collaborate cross‑functionally with Manufacturing, Quality, Engineering, and Technical Services.

Connaissances

CAPA and investigations

Deviations handling

Data trend analysis

Process improvement

Laboratory analyses

Cross-functional collaboration

Formation

Bachelor's degree in Chemical Engineering, Biological Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Description du poste

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 require immunization before performing work within the manufacturing area.

Other Job Requirements

• 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: USA - IL - Round Lake - Drug Delivery

U.S. Base Salary Range: $89,900.00 - $141,240.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes