Clinical Affairs Lab Tech 2 (Scientist) at Biomerieux, Inc

Posted in Other 10 days ago.

Location: St. Louis, Missouri

Job Description:

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

Position Summary:

As a Clinical Lab Tech 2, you will contribute to the conduct of clinical trials carried out for registration purpose on new in-vitro diagnostic solutions developed by bioMérieux (reagent, instrument, software) or for regulatory compliance purpose on existing IVD solutions already on the market.

Primary Responsibilities:

  • Carry out the experiments and tests required for clinical studies of simple to moderate complexity, while respecting the study protocol and its requirements, the timelines and all applicable Quality Assurance and Safety standards

  • Carry out the experiments and tests required as part of the validation of the instruments and their configurations in accordance with the study protocol and its requirements

  • Provide accurate, high quality test results and reliable data

  • Document and record all activities to ensure traceability and quality of the clinical studies conducted

  • Contribute to the preparation of clinical studies carried out on external sites in the US by managing all logistical, administrative, operational and technical activities: ordering of materials, preparation of biological materials (samples and strain sets), shipments to external sites, tracking of supplies, management of instrument configurations and qualifications on site, follow-up of instrument calibration and maintenance

  • Contribute to site visit and study set-up on external sites in the US by providing technical training to site operators for instrument, reagent, testing and data management in accordance with the study protocol

  • Provide Level 1 support to external sites by managing complaints and technical problems observed during the conduct of clinical studies

  • Participate in the maintenance and management of the Clinical Affairs laboratory in accordance with the applicable Quality Assurance and Safety standards

Education and Experience:

  • Bachelor's degree in Microbiology, Biology, Biochemistry, Medical Technology or related field.

  • Medical Technician License preferred.

  • 2+ years of laboratory experience

Knowledge, Skills and Abilities:

  • Ability to travel up to 30%

  • Scientific knowledge and advanced organizational skills (laboratory reference techniques, norms and standards for the conduct of experiments and tests) allowing an autonomous realization of technical tasks

  • Thoroughness, ability to perform complex and technical demanding tasks

  • Ability to work in a team and in interface with many other bioMérieux internal functions

  • Teaching skills to transfer technical knowledge to peers in Europe (training of operators on external sites)

  • Ability to positively represent the laboratory and Clinical Affairs department outside bioMérieux

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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