Remote: Analytical Lab Qualifying Auditor (232391)

Life Sciences & Technology

Job Description 

Client is looking to vet 2 or 3 QC Labs to do testing for their CAR-T (anti-CD33) therapy for Acute Myeloid Leukemia.
Goal is to conduct Vendor Qualification Audit of these potential laboratories regarding their capabilities and ability to provide the testing methods and results needed by the client and capabilities for analytical development.

Required Skills/ Experience 

Experts in QC Lab audits (CLIA labs) is required, and experience in hematology/oncology is strongly recommended.
The labs will be looking at various biomarkers, cytokines, the CAR-T material itself, plus CD33 exposure, SNP genotyping, PK, and flow cytometry (MRD assessment).

Remote: Analytical Lab Qualifying Auditor (232391)

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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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