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Job Description

About the role:

As a Quality Control Senior Analyst, you will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies. Testing may include samples from drug substance/product and multiple protocol studies using test methods derived from the compendia and non-compendial sources. You will maintain operational and GMP readiness of the QC area. Also, you will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and multiple quality systems (deviations, change controls, investigations), and maybe asked to take lead roles for the QC organization on these projects. You are expected to act as a role model for junior staff in the QC areas. You will report to Quality Control Supervisor.

How you will contribute:

• Product testing: Areas of focus on techniques such as Western Blot, SDS-PAGE, ELISA Potency and Bioassays
• Establish and recommend changes to policies which effect subordinate organizations.
• Work is reviewed and measured based on meeting objectives and schedules.
• Provide guidance to subordinates to achieve goals following established policies and receive assignments in the form of objectives and establishes goals to meet objectives.
• Participate in determining objectives of assignments. Plan schedules and arranges own activities in accomplishing objectives. Work may be reviewed upon completion for adequacy in meeting objectives
• Exert some influence on the objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
• Role is responsible for Cell Biology laboratories performing a broad range of techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing
• Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.
• Support Quality projects and implementation of operational excellence initiatives.
• Product testing: Areas of focus on techniques such as Western Blot, SDS-PAGE, ELISA Potency and Bioassays
• Establish and recommend changes to policies which effect subordinate organizations.
• Testing execution, participate in training analysts, trouble shooting of methods
• Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
• QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)

What you bring to Takeda:

• Typically requires a bachelor's degree and 4+ years of related experience. (science related degree would be ideal).
• 5S/OE experience.
• Method transfers.
• Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices.
• MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding
• Previous experience in a GMP QC role would be ideal.

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. 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.

#GMSGQ #ZR1 #LI-MA1

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 - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$86,500.00 - $135,960.00

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 - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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