World leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.
bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l’Etoile, near Lyon, in France.
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.
We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.
We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.
Our Group offers numerous possibilities:
so come and join the 10,000 bioMérieux employees who have already identified with these values!
Primary Purpose and Overall Objective of the Job:
As part of the Industrialization Analytical department, the Process Scientist (Microbiologist) will perform projects to support the manufacturing of BACT/ALERT® Culture Media products. Within this role the Process Scientist will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain, and other functions as required, in order to ensure successful project achievements to facilitate quality production that meets on-time customer demands.
In this position the Process Scientist’s primary focus will include the analysis of biologically derived raw materials for secondary/alternate sourcing projects for site securitization and/or cost savings initiatives. Analysis includes hands on laboratory testing at the bench scale, within final product, and through large scale validation activities. Strong knowledge of cGMP microbial testing (environmental monitoring, bioburden, and others) will be required, along with understanding upstream impact to manufacturing. Management of multiple projects will be required, whereby assessments are generated to assess interim progress and effectiveness. Project leadership is necessary in order to guide timelines, adjust expectations, and collaborate cross-functionally. This position will require a strong knowledge of microbiology in order to provide subject matter expertise in evaluating raw material and process changes in both planned and unplanned circumstances, represent microbiological expertise on cross-functional teams, as well as, participate and identify improvement opportunities and strategies.
Education and Experience:
B.S. in Microbiology or closely related field, with 5+ years of experience.
M.S. in Microbiology or closely related field, with 3+ years of experience equivalent required.
Preferred experience in a FDA regulated cGMP/GxP industry.
Skills and Qualifications:
Robust technical background in microbiological methods, aseptic technique, and environmental monitoring.
Basic SAP knowledge, or a related ERP system.
Statistical software competence, Minitab preferred.
Experience with implementing changes/qualifications through change control process.
Strong project management skills, familiarity with Microsoft Project.
Direct experience in authoring and review/approval of SOPs.
Agility to re-prioritize workload independently due to business needs.
Exhibit instrument and method trouble shooting skills.
Self-directed individual who can work with limited direction.
Excellent organizational, analytical, and communication skills.
Demonstrated ability to work in a team environment.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity
: AMER-AMER-US-NC-Durham, NC
: Mar 1, 2019, 11:27:11 AM
: Day Job
: Yes, 10 % of the Time