Site Microbiologist
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Job Location:
Brooklyn Park, MN - USA
Monthly Salary:
$ 111800 - 175670
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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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 sites 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
- 37 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 MNU.S. Base Salary Range:
$111800.00 - $175670.00
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 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 MNWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesRequired Experience:
IC
Key Skills
- Laboratory Experience
- Aseptic Technique
- Virology
- Clinical Laboratory Experience
- FDA Regulations
- Laboratory Procedures
- PCR
- Microbiology
- Quality Control
- GLP
- cGMP
- Laboratory Information Management Systems
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
