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Job Description

About the role:

Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.  Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols.  May assist in sampling activities.  This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities.  In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.

How you will contribute:

• Area focuses on 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.
• Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
• Testing execution, participate in training analysts, trouble shooting of methods
• 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)
• Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support

What you bring to Takeda:

• Typically requires a bachelor’s degree and  a minimum of 5+ years of related experience. (science related degree is preferred)

• Previous experience in a GMP QC role is preferred

• Complete understanding and application principles, concepts, practices and standards.

• Full knowledge of industry practices

• MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding

• Travel between sites is required.

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.

• Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)

• Ability to work around chemicals (if working around the laboratories)

• Ability to walk and stand for periods of time

• Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

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, encou