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Job Description

About the Role:

As the Quality Control Analyst II - Bio Chemistry, you will focus on the daily lab operations and execution of testing to support manufacturing operations. Testing may include samples from drug substance and drug product, manufacturing, stability, raw materials and various protocol studies using test methods. The assays range from pH, enzyme concentration to more complex assays such as SDS silver Gels, PCR, and enzyme activity. You will maintain operational and GMP readiness of the QC areas and participate in more complex projects, operational excellence projects and quality systems.

You will report to the Quality Control Supervisor.

How you will contribute:

• Testing execution of A280, SOLO A280, Compendial methods (pH. Moisture, OSMO, Appearance, Subvisible particles), Enzyme Activity assays, PCR, Free Thiol.

• Data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab house keeping, support for other QC groups.

• Compliance and quality systems (SOP revisions, input to quality system records).

What you bring to Takeda:

• Bachelors degree and minimum of 2+ years of experience of QC testing.

• MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and proven science understanding.

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 time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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.

• Limited to no travel expected.

• Repetitive bending and reaching to setup and break down equipment

• Walk and stand for periods of time

• Individual may be required to participate in an environment 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, encourages innovation, and strives for excell