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. Primary Purpose and Overall Objective of the Job:
As part of the Industrialization Analytical department, the Process Scientist (Chemist) 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. Main Accountabilities:
In this position the Process Scientist's primary focus will include the analysis of chemical raw materials for secondary/alternate sourcing projects in order to achieve site securitization and/or cost savings initiatives. Analysis includes hands on laboratory testing at the bench scale, performance testing on final product, and large scale validation activities. Strong knowledge of cGLP and cGMP, practical lab experience of liquid chromatography and gas chromatography is preferred, along with understanding impact to both upstream and downstream processes when considering raw material changes. 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 chemistry in order to provide subject matter expertise in evaluating raw material and process changes in both planned and unplanned circumstances, provide expertise and representation on cross-functional teams, as well as, participate and identify improvement opportunities and strategies. Education and Experience:
Skills and Qualifications:
- B.S. in Chemistry or closely related field with 3 years of experience OR M.S. in Chemistry or closely related field with 1 year of experience.
- Preferred experience in a FDA regulated industry.
- Robust technical background in chemistry formulations and analytical chemistry methods.
- Basic SAP knowledge, or a related ERP system.
- Computational aptitude for scaling formulation recipes
- Knowledge of PCR technique, experience in testing and analysis preferred.
- Experience with data analysis and 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 documentation.
- 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 written/oral communication skills.
- Demonstrated ability to work in a team environment.
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.
Job ID: 16069 Nearest Major Market:
Durham Nearest Secondary Market: