Zimmer Biomet - Manufacturing Scientist
Claymont, DE - can assist w/ relocation
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We offer competitive wages and excellent benefits!
We are looking for an experienced Manufacturing Scientist, 3+ years
Supporting daily production, testing needs of a Reagent Manufacturing team. Includes investigation, resolution of assay failures during in-process or final testing. Includes maintenance of BOM, material specification changes due to new material qualification or supplier changes & updating/correcting SOPs in compliance with current quality system standards. Supports routine production, testing of reagents for IVD assays. All work will be in compliance with governing regulatory requirements; FDA, ISO 13485, QSR. Activities; maintenance, validation and calibration of equipment. Experience with immunoassays is required, ELISA and lateral flow technology is highly preferred.
This role produces diagnostic solutions for patients with joint pain and inflammation that aid in a more informed diagnosis.
- Provide technical expertise and direction in multiple Immunoassay manufacturing areas (bioanalytical testing)
- Lead multi-department teams to support/resolve non-conforming issues for existing products
- Communicate investigation status reports, proposals for further investigation, etc. via oral and written reports; develop and implement changes to existing documentation in a timely manner
- Solve immunoassay testing and manufacturing issues as they arise
- Carry out routine reagent production, testing for the manufacture of IVD tests (in vitro diagnostics)
- Training of laboratory personnel
- Assess manufacturing processes and systems, and implement improvements aimed at performance, quality, and cost
- Assure compliance with FDA Quality System Regulations (QSR), Good
- Manufacturing Practice (GMP), and ISO regulatory requirements
- Create validation protocols, execute, draw conclusions and author reports
- Interpolate and analyze data, use of various graphing programs
- Use of statistical analysis (including control charts)
- Create and revise standard operating procedures
- Ensure accuracy of bill of materials and update as required
- Understands, promotes, enforces all applicable safety protocols including chemical, biological hazards, labeling, containment, and waste handling.
- Understand product application and customer expectations
- Work as a member of interdepartmental project teams
- Bachelor’s Degree in a scientific or engineering related field is required. Biochemistry, microbiology, biology, cell biology
- Advanced degree (MS/PhD) preferred and can substitute for experience. 1-2 years experience w/ advanced degree.
- 3+ years of experience in a relevant production/manufacturing environment.
Our culture promises represent our shared commitment for how we work together to deliver on our mission. Zimmer Biomet is an equal opportunity and affirmative action employer. We invite all interested and qualified candidates to apply for employment opportunities.
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.