What are the responsibilities and job description for the Associate Process Scientist position at bioMerieux Inc.?
Description
Position Summary:As part of the Analytical Production Securitization Industrialization team in the Engineering and Industrialization department, the Associate Process Scientist, Biochemist will perform projects to support the manufacturing of BACT/ALERT Culture Media products. Within this role the Associate Process Scientist will be required to interface with Manufacturing, Quality Control, Quality Assurance / Validation, R&D, Purchasing, Supply Chain, Warehouse, and other functions as required to ensure successful project achievements to facilitate quality production that meets on-time customer demands.
Primary Responsibilities:
- Primary focus will include the analysis of both biological and chemical derived raw materials for secondary/alternate sourcing projects to achieve site securitization and/or cost saving initiatives.
- Provide subject matter expertise in evaluating raw material and process changes in both planned and unplanned (expedited) circumstances.
- Manage multiple projects, whereby data backed recommendations are prepared to evaluate interim progress and effectiveness, i.e., authoring technical reports/assessments, study protocols/reports, and validation documentation.
- Assess impact to both upstream and downstream processes when considering raw material, instrumentation/equipment, and process changes.
- Manage Change Controls.
- Author/revise documentation/SOPs.
- Develop Job Aids to support routine activities.
- Represent the department on cross-functional teams, as well as, participate and identify improvement opportunities.
- Champion root cause analysis.
- Perform all work in compliance with company quality procedures and standards.
- B.S. in Chemistry, Biology, Biochemistry, Biomedical Engineering, or related field with 0 years of experience required. M.S. preferred.
- 1 year of Project Management experience preferred.
- 1 year of experience working in a cGMP FDA regulated environment preferred.
- Experience with data analysis and statistical software competence, Minitab preferred.
- Project management skills and familiarity with Microsoft Project preferred
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