Remote: QC Stability Consultant (Director-level) (233811)

Life Sciences & Technology


Remote w/ travel to CMO in Irvine, CA (expenses covered for travel 3-4x total throughout a 6 month span)


6 months

Job Description:

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.

Minimum Requirements:

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)



About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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