The Product Transfer Associate will provide support to the Senior Product Transfer Scientist ensuring the successful transfer and validation of controls materials into manufacturing for Cepheid’s new IVD product. Duties include developing procedures for reagent manufacturing and testing, developing bills of materials (BOM) for internal and external control materials, coordinating manufacturing activities, drafting and executing process validation protocols, and writing reports. This position will have active interactions with R&D, Reagent Manufacturing, and other functions within Operations.
- Participate and report to a cross-functional product transfer team to support test materials production activities
- Act as technical expert to design and execute process development and validation studies to establish a robust operating and performance system for test material manufacturing
- Perform hands-on activities that support process development, characterization and validation, including identify, evaluate, and characterize equipment and/or automation required to advance production, process improvements, safety, and efficiencies, draft and review procedures, execute pilot studies, and perform equipment qualification in a cGMP environment (IQ, OQ, PQ).
- Assist successful manufacturing production runs by assessing risk, providing preventative measures, investigating, and troubleshooting equipment and process issues