Duration
4 weeks +/-
Job Description
Our client is currently seeking a Cleaning Process SME relative to chromatography processes. The overall objective will be to the SME to put together the strategy as well as authoring of risk assessment summary report and verification & validation of chromatography processes. The client uses a Cytiva AKTA process chromatography system to produce RNA for a couple of different products. The upcoming GMP run will take place the first week of June therefore the client needs to be fully prepared for the upcoming GMP run with documentation and procedures in place to complete the first cleaning cycle with successful results in hand.
The Risk Assessment & Summary Report should include areas of focus such as: Analytical strategies (TOC, pH, bioburden, conductivity, endotoxin): TOC swab recovery studies, visual inspections (what passes & what fails), acceptance criteria for assays (using WFI or MAC specs regarding various products & overall patent safety). Sampling Strategies (is visual or TOC swabbing necessary, testing locations, final rinse sample). Cleaning agent (using 1M NaOH due to lack of capability for hot cleaning solutions). Cleaning processes (CIP method, justified flow rates and hold time duration in NaOH).
It will be very helpful if the consultant has previous templates to utilize for SOP’s that need to be written (such as the visual inspection SOP if it is recommended). Experience with GMP processes, cleaning verification & validation, chromatography systems and working with large pharma companies (example: Sanofi, Roche, etc.) is mandatory for this position. 10+ years of experience with relative job scope is required.
Remote: Cleaning SME (234666)
#LI-Remote
