Our client is seeking a Sr. Bioanlaytical Lab SME to come onsite and perform a Gap assessment and assist with lab buildout. Currently the client has a small team supporting an early Phase I program and ramping up to start a second Phase I trial. The lab is very new and needs to be brought up to GLP standards. They need an SME to perform the Gap assessment and provide a strategic plan to ensure compliance. This will include SOP’s writing for lab equipment, processes, procedures, and performing training. Once the lab is compliant, it would be beneficial if the candidate has method validation experience to assist the team with the new programs. Of the two programs, 1 is a Combo product entering clinical (Protein & Cell therapy) and a Protein program. The ideal candidate will have experience with flow cytometry and chromatography lab systems & equipment.
Bioanalytical, Gap Assessment, GLP, SOP development/writing, Method Validation, Flow cytometry, Chromatography
Ideally Bioengineering or relatable
CA: BioAnalytical Lab SME (232850)