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Job Description

About the role:

As the Site Microbiologist, you will oversee activities within the facility to ensure the microbial quality, safety, and compliance of pharmaceutical products, raw materials, utilities, cleanrooms, and manufacturing processes. You will support routine operations, investigations, environmental monitoring (EM), contamination control strategies (CCS), method development, and regulatory compliance within GMP environments. You will hold a PhD in Microbiology or a related field and have experience in virology within a regulated environment. You will report into the Site Quality Head.

How you will contribute:

+ Perform and/or oversee microbiological testing including bioburden, endotoxin, sterility testing, microbial identification, growth promotion, and water system monitoring

+ Ensure all testing complies with GMP, SOPs, and pharmacopeial standards

+ Oversee troubleshooting and qualification of microbiology laboratory equipment and advanced microbial detection systems

+ Manage the Environmental Monitoring (EM) program, including trend analysis, alert/action limit review, and CAPA activity

+ Support and continuously improve the site's Contamination Control Strategy (CCS)

+ Supervise personnel monitoring, viable and non-viable particulate monitoring, and surface sampling in compliance with EU GMP Annex 1 and FDA guidance

+ Lead microbiology-related investigations, including EM excursions, OOS/OOT results, sterility failures, and water-system deviations

+ Provide microbiological expertise in risk assessments, CAPAs, change controls, and root cause analyses

+ Collaborate with QA, Engineering, and Operations to proactively identify and mitigate contamination risks.

Minimum Requirements/Qualifications:

+ PhD in Microbiology, Virology, Biotechnology, or a closely related life sciences discipline

+ 3–7 years of experience in pharmaceutical microbiology

+ 3+ years of experience with GMP, aseptic processing, and regulatory microbiology requirements

+ 3+ years of experience in environmental monitoring, sterility assurance, and contamination control

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.

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:

Brooklyn Park, MN

$111,800.00 - $175,670.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes