Remote w/ travel to CMO in Irvine, CA (expenses covered for travel 3-4x total throughout a 6 month span)
Our client is currently seeking an Associate Director/Director-level resource with a strong QC background who can manage, troubleshoot and direct the stability program that is being conducted at the CMO. Our client works with enzyme or protein-based products and any knowledge on related products lines will be helpful for the scope of work. The resource will be expected to reel in the current CMO and alleviate ongoing discrepancies with the stability program for drug product & drug substance. There is one asset in Phase I Clinical Trials with a couple more in the pipeline that are in preclinical and discovery. The main glaring areas of concern are as follows: analysis being performed on time (pools made for stability, analyzing data report results), scheduling issues, inability to perform assays, etc. There will be work on troubleshooting assays for stability testing and assisting staff with the execution of those assays.
The selected resource will be introduced to the CMO and internal team from Manufacturing & Quality. There will be a giant dump of stability protocols and reports with data and the resource will be required to review current project status, meet with the CMO, and ultimately come up with list of observations that they have caught to provide recommendations on resolving issues.
Proven track record in conducting clinical trials in the US, ICH & CFR regulations pertaining to manufacturing and testing while managing an outsourced stability program.
Hands-on interface/involvement with 3rd party labs or CMO’s
Troubleshooting assays and test methods
AD/Director-level expertise with at least 5-8 yrs of decision-making skills (including management of QC programs) and 10-15 years of overall experience.
Bonus/Nice to have:
Protein & Enzyme-based product lines
Remote: QC Stability Consultant (Director-level) (233811)