Position Summary
Responsible for developing controls, calibrators, working solutions, and intermediates according to approved standard operating procedures in an in vitro diagnostics environment. Responsible for developing quality products on schedule. Applies general laboratory research knowledge and practices.
Duties and Responsibilities
- Develop OEM in-vitro diagnostic controls and calibrators (Cardiac, Immunoassay, Urinalysis, Tumor Markers, Drug monitoring, Proteins).
- Assist in developing new products/methods; optimize/refine current product lines.
- Create products using approved procedures; maintain detailed, accurate records.
- Prepare feasibility, development, and transfer summary reports.
- Perform in-process analyses; adjust analytes to meet specification.
- Troubleshoot and support root cause analysis (basic).
- Manufacture liquid chemistry/serum-based bulks, intermediates, stock solutions, and raw materials.
- Verify instrument/procedure readiness; perform maintenance and calibrations as needed.
- Measure quantities volumetrically/gravimetrically; apply chemical/biochemical handling knowledge.
- Continually evaluate and/or create work instructions, QCRs, SOPs; modify through formal change process.
- Perform documented processing steps (centrifugation, diafiltration, filtration, column separation).
- Perform final release testing on analytical instruments.
- Perform aseptic procedures (filtration, filling, capping, microbial plating).
- Assist with training, validation testing, assay testing for value assignment, and new product transfer.
- Assist with laboratory/equipment maintenance and cleanliness; special projects as assigned.
Minimum Job Requirements
- Bachelorβs degree in Chemistry, Biochemistry, Biological Science, or related field (preferred).
- 1β3 years work experience in in vitro diagnostics, medical device, pharmaceutical, or related industry (required).