Sr. Microbiologist - (28764)

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

WHAT WE'RE LOOKING FOR:

The Sr. Microbiologist conducts diverse biological assays on raw materials, in-process samples, finished products, and environmental monitoring samples, following USP, FDA, and regulatory guidelines. Utilizes specialized techniques for qualitative, quantitative, and investigative analysis. Ensures compliance with Guerbet’s SOPs and license requirements. Compares results with specifications, documents findings, and collaborates with Microbiology lab personnel to uphold testing protocols. This position is located in Raleigh, NC on 1st shift Monday through Friday.

 

YOUR ROLE:

• Leads diverse protocols, including environmental studies and validations, for microbiology testing services. Conducts biological assays, troubleshoots technical issues, and performs method validation with minimal guidance.

• Ensures scientific suitability of test methodologies, investigates and resolves problems, and teaches gown qualifications within a team environment

• Ensures testing result accuracy and validity, analyzing monthly microbiology data to identify and correct potential product quality concerns.

• Leads studies supporting sterilization and endotoxin removal validation, performing mathematical calculations and maintaining precise records.

• Develops problem-solving skills, utilizing Laboratory Information Management Systems, and compiles data for reports related to investigations, APQRs, KPIs, QMRs, and validations.

• Maintains records, prepares materials, and keeps the work area organized. Coordinates testing activities and represents the microbiology department in process improvement teams.

• Supports inventory management and protocol execution, ensuring the laboratory meets audit requirements. Records results and performs special testing, instrument, and process validations.

• Takes an active role in laboratory QA functions, including OOS investigation, SOP management, validation activities, and auditing, contributing to maintaining an audit-ready status for global regulatory compliance.

• Trains and mentors more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor.

• Analyzes and interpret project/study/investigation results and findings

• Review and approve QC test results as well as logbooks for accuracy and completeness and conformance to SOPs.

 

YOUR BACKGROUND:

Education required/preferred:

• Bachelor’s Degree preferably in Microbiology, Biology or similar life science

Experience:

• Minimum 6 + years working in Microbiology, preferably in the pharmaceutical industry

Preferred Skills/Qualifications/Competencies:

• Good interpersonal and verbal/written communication skills; able to use computer for data analysis

• Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements.

• Self-motivated, energetic, enthusiastic, and team oriented.

Other Skills:

• Ability to train personnel on various procedures. MS Excel, PowerPoint, Access, and investigation writing.

• Effective communication with both team members and other plant support groups.  

 

EQUAL EMPLOYMENT OPPORTUNITY 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity an