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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Microbiologist II

Job Summary

Performs biological assays of clinical and/or commercial product raw materials, production in-process samples, finished product, environmental monitoring samples, process & cleaning validation samples and components as well as some specialized techniques. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Guerbet’s standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has mastered most fundamental technical and quality concepts. May provide guidance and training to more junior staff members.

Position Responsibilities

  • Performs biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components.
  • Laboratory assays included Particulate testing, growth promotion of media, sterility testing, raw material testing, bioburden, membrane filtration, plate reading, endotoxin testing and environmental monitoring.
  • Works in a team environment to support internal and external customer microbiology testing services. Identifies basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation process to resolve and correct.
  • Performs studies to support the validation of test methods and ongoing validation studies as needed.
  • Ability to teach and perform gown qualifications for all personnel in the facility. Implements on-going studies to document the scientific suitability of test methodologies fundamental to conformance and assessment.
  • Analyzes results
  • Accountable for the accuracy and validity of testing results.
  • Performs mathematical calculations, interprets results, and records observations.
  • Ability to keep accurate records and performs monthly trend analysis for microbiology data to identify potential concerns with product quality and correct deviant situations. May utilize Laboratory Information Management Systems.
  • Develops problem solving skills.
  • Trains more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor.
  • Mentors analysts by providing technical knowledge and support in resolving technical problems and reviewing documents. Takes initiative; seeks out additional assignments, etc.
  • Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner.
  • May assist in coordinating the testing activities of the group. Ability to represent the microbiology department on relevant teams (Kaizen, Lean Sigma) to help improve processes throughout the facility.
  • Assist in maintaining inventory and reconciliation of laboratory supplies and assist in protocol execution when needed. 
  • SOPs and Admin Learns to analyze and interpret project/study/investigation results and findings.
  • Determines next steps under guidance of manger and in compliance with applicable regulations; carries out technical and administrative duties as assigned.

Minimum Requirements

  • Preferably a Bachelor’s Degree in Microbiology, Biology or similar life science
  • Minimum 4 + years laboratory experience, preferably in the pharmaceutical industry.
  • 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.
  • Microbiology
  • Self-motivated, energetic, enthusiastic, and team oriented.
  • 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.