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Job Description

About the role:

As a Research Specialist where you will provide process support to the Fractionation manufacturing group by solving technical issues within the Social Circle Fractionation manufacturing facility. You will assist your quality and manufacturing partners in maintaining process compliance, aiding in the implementation of yield and process improvements, and supporting process validation activities. As part of the Fractionation Manufacturing Sciences team, you will report to the Associate Director of Manufacturing Sciences, Fractionation.

How you will contribute:

• Troubleshoot and provide resolutions to technical issues to support ramp-up and steady-state operations of pharmaceutical manufacturing facilities.

• Evaluate and prepare product impact assessments for process exceptions.

• Act with guidance to conduct smaller yield and cycle time improvement projects.

• Work with Manufacturing to help promote essential metrics such as yields and capacity.

• Track and trend yield and report on the essential metrics.

• Work to implement experiments in the Manufacturing Sciences lab.

• Support teams to resolve complex problems.

• Contribute to process validation protocols and final reports (e.g. process performance qualification, mixing study, hold study, etc). Coordinate and support training and execution of validation activities.

• Promote the use of DMAIC tools in projects.

• Analyze scientific, and statistical data to draw appropriate conclusions.

• Actively support information sharing and learning between team members.

• Provide technical support for equipment in manufacturing, as second level support. Gain knowledge of systems to grow into an expert (SME) role.

Minimum Requirements/Qualifications:

• Typically requires bachelor’s degree in a science or other related technical field.

• Knowledge of FDA-regulated manufacturing environments is desired.

• Practical and theoretical knowledge of the purification of plasma proteins and biochemistry.

• Experience with basic scientific principles in various scientific disciplines.

• Ability to discuss normally encountered technical and project management issues, both verbally and in written form.

• Must embrace working in a fast-paced, team-oriented, cross-functional environment.

• Experience with Minitab or other statistical software preferred.

• Ability to participate in small teams and work as a collaborative team member.

• Training in concepts of Lean Manufacturing and/or Six Sigma quality techniques is preferred.

• Ability to work shifts including nights, weekends, and holidays in support of project execution on an infrequent basis (< 5%).

• Ability to work in a clean room environment for extended periods of time.

• Ability to wear personal protective equipment (such as hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.

• Ability to travel on an infrequent basis (< 5 %)

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous paid time off for vacation, sick leave, and volunteering

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional development and training opportunities

• Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More About Us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

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