Job Description
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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
U.S. Base Salary Range $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.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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
Job Tags
Minimum wage, Full time, Temporary work, Local area,