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Job Description

As the Supervisor Microbiology, you will supervise a team performing multiple biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. You will be responsible for results regarding product quality and conformance to regulations and quality policies.

How you will contribute

• Plan and schedule the work of QA analysts, QA technicians and inspectors.
• Ensure that all document control activities, inspection, and test procedures are completed and documented.
• Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
• Coordinate the release of licensed products, intermediate and clinical/IND lots, and Packaging, according to schedule.
• Track performance indicators such as average number of defects per million units inspected as a process average for all products and document control and retention schedule adherence.
• Work with Production Supervision, Quality, and Engineering to ensure adequacy and appropriateness of inspection parameters, product specifications, test methods, and other controlled documentation.
• Evaluate new raw materials to develop first of code criteria for raw material testing.
• Prepare daily reports and monthly summary on department specific performance indicators.
• Maintain inspection documentation procedures, QA inspection instructions and department policy procedures. Ensure product compliance regulations are followed.
• Oversee the team and direct management of individuals, including goal setting, performance feedback, skills development and mentoring.Navigate, answer alerts and review Batch Records in EBM.
• Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
• Responsible for change control activities/documentation. Required to perform review of submission documents applicable to the product of the department.
• Coordinate quarterly review meetings of quality data and trends to upper management.
• Coordinate customer complaint response and tracking.

What you bring to Takeda

• Typically requires a bachelor's degree in science, engineering or other related technical field and 5+ years of related experience.
• Some leadership experience.
• Working knowledge of statistics and production processes.
• Must have AS400 or PC knowledge.
• Identify when proper practices/ procedures are not performed.
• Follow SOPs and identify processes and results.
• Complete changes and corrections.
• Driver of task proficient.
• Escalate accordingly.
• Ensure communication of issues.
• Ensure communication between personnel, groups, and between departments.
• Coordinate activities, schedules staff.

Important Considerations

• In general, you will have a combination of sedentary work, standing work, and walking around observing conditions in the facility.
• Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
• May work or be assigned to a different shift to meet needs. Must be willing to work off shifts hours.
• Will work supplemental hours to complete work commitments.
• May work in a confined area.
• Inside working conditions.
• Some clean room and cool/hot storage conditions.
• You may be allocated in QC Analytical, Microbiology, Compliance, QCMIS, and Laboratory Operations with general job requirements summarized below:
• Wet/dry chemistry or biochemistry test methods, compendial raw material testing, maintenance of associated assay equipment, and reconcilitation of test results.
• Environment monitoring, critical utility sampling, endotoxin testing, bioburden for raw materials and in process, process samples, microbial identification and final product sterility testing.
• Manage and investigation of non-comformance events (OOL, OOS). Develop the site Contamination Control Master Plan (CCMP).
• Development, validation, and optimization of departmental assays.
• Support laboratory operations through sample control, equipment metrology, data reconciliation/ archiving, or computerized system programming and support.

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.

This posting excludes Colorado applicants.

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.

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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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