Position Summary
- Responsible for developing controls, calibrators, working solutions, and intermediates according to approved SOPs in an in vitro diagnostics environment.
- Responsible for developing quality products on schedule.
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 or optimizing/refining current product lines.
- Create products using approved procedures; keep detailed, accurate records.
- Prepare summary reports for Feasibility, Development, and Transfer.
- Perform in-process analyses and adjust to bring analytes into specification.
- Apply basic troubleshooting and root cause analysis.
- Manufacture liquid chemistry and serum-based bulks, intermediates, stock solutions, and raw materials.
- Verify instrumentation/procedures; perform maintenance and calibrations as needed.
- Measure quantities volumetrically and gravimetrically.
- Develop/update work instructions, QCRs, SOPs and related documents; modify via formal change process.
- Perform processing steps (e.g., centrifugation, diafiltration, in-process filtration, column separation).
- Perform final release testing.
- Perform aseptic procedures (filtration, filling, capping, microbial plating).
- Assist with training, validation testing, assay testing for Value Assignment, new product transfer, and lab/equipment maintenance.
- Special projects as assigned; additional functions as required.
Minimum Job Requirements
- Bachelorβs degree in Chemistry, Biochemistry, Biological Science, or related field (preferred); 1β3 yearsβ experience in in vitro diagnostics, medical device, pharmaceutical, or related industry (required).
Benefits (explicitly stated)
- Competitive insurance starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, legal and ID shield.
- 401k, ESPP, HSA, FSA, Dependent Care FSA.