Process and Product Science, Senior Analyst

USA - 3390 Baxalta U.S., Inc.; Round Lake (IL); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a Process and Product Science, Senior Analyst at Libertyville, IL. The role emphasizes deviation and CAPA support, data-driven investigations, and cross-functional collaboration to improve yield and manufacturing robustness.

You will perform basic lab analyses and author technical protocols, contributing to compliant, high-quality production. The position requires 5+ years in regulated manufacturing, a related bachelor’s degree, and strong GMP knowledge.

Qualifications

• 5+ years of related experience in pharmaceutical/biotech manufacturing environments.
• Experience applying scientific and engineering principles to manufacturing processes, product performance, investigations, or process improvement.
• Working knowledge of GMP regulations, quality systems, and manufacturing process controls.

Responsibilities

• Provide deviation and CAPA support, including authoring and reviewing records per GMP/site procedures.
• Serve as SME for investigations, evaluating data to determine root cause and impact.
• Plan, lead, and execute yield improvement projects with limited supervision.
• Apply engineering principles to improve manufacturing processes for efficiency and robustness.
• Collaborate with Manufacturing, Quality, Engineering and Technical Services to implement improvements.

Skills

CAPA investigations

Data analysis

Documentation

Cross-functional collaboration

GMP knowledge

Education

Bachelor's degree in Chemical Engineering (or related sciences)

Job description

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.

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. For information about our benefits, please click here.

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

About Takeda

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.

Accommodation for Applicants with Disabilities

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