Scientist II, Analytical Development, Gene Editing and Molecular Assays
$110,706–$145,303 year
On-site · Somerset, New Jersey, United States
Job Summary
Scientist II in Analytical Development, Gene Editing and Molecular Assays based in Somerset, NJ, responsible for developing analytical methods and performing QC/testing to support the manufacture and characterization of Legend’s gene and cellular therapy products. Responsibilities include method development, qualification and transfer; routine GMP testing of final product, stability and in-process samples; data review and verification; lab maintenance; cross-training; authoring and revising technical documents (test methods, SOPs, specifications, trend reports, sample plans); maintaining lab notebooks; equipment management; material procurement; and collaborating with the Analytical Development team to establish analytical control strategies. Requirements include a BS/MS/PhD in a related field and 6-8 years (BS) or 4-6 years (MS) or 1-3 years (PhD) of assay development and GMP QC testing experience; proficiency with qPCR/dPCR/ddPCR, ELISA, cell-based assays; knowledge of cGMP; strong communication and teamwork; experience with LIMS/ELN (Veeva), GraphPad Prism, JMP, and LabVantage; Mandarin preferred.
Required Qualifications
- BS, MS or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or a related field
- 6-8 years of practical experience with BS; 4-6 years with MS; 1-3 years with PhD in assay development and GMP QC testing in biologics/therapeutics
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