Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
Responsible for supporting the daily production and testing needs of a Reagent Manufacturing team. Includes investigation and resolution of assay failures during in-process or final testing. Includes maintenance of bills of materials, material specification changes due to new material qualification or supplier changes and updating/correcting SOPs in compliance with current quality system standards. Supports the routine production and testing of reagents for IVD assays. All work will be in compliance with governing regulatory requirements such as FDA, ISO 13485, and QSR. Activities may include maintenance, validation and calibration of equipment. Experience with immunoassays is required, ELISA and lateral flow technology is preferred.
Principal Duties and Responsibilities
Provide technical expertise and direction in multiple Immunoassay manufacturing areas
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 and testing for the manufacture of IVD tests
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 statistical analysis (including control charts)
Use of various graphing programs
Create and revise standard operating procedures
Ensure accuracy of bill of materials and update as required
Understands, promotes, and 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
Expected Areas of Competence
Candidates with practical experience in the development, validation and/or manufacture of diagnostic assays is required
Work experience with ELISA assays is preferred
ISO 13485 or cGMP experience preferred
Proficiency in Microsoft Office software is required.
The ability to read, interpret and analyze scientific data is required.
The ability to effectively communicate through written and oral form is required, along with strong organizational and time management skills
Bachelor’s Degree in a scientific or engineering related field is required. Advanced degree (MS/PhD) preferred and can substitute for experience.
3+ years of experience in a relevant production/manufacturing environment.
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.