Responsible for performing laboratory testing of raw materials, drug substances, drug products, in-process samples, and stability samples using analytical instrumentation.
Compensation
Pay: $40.00- 44.00/hr to start.
Responsibilities
Perform laboratory testing of raw materials, drug substances, drug products, in-process samples, and stability samples using analytical instrumentation
Conduct routine wet chemistry and analytical testing using HPLC, GC, UV-Visible Spectroscopy, CGE, ICE, polarimeters, osmometers, pH meters, conductivity meters, and TOC analyzers
Provide scientific leadership for analytical development (AD) supporting next-generation mRNA-LNP-based in vivo CAR-T therapies within the Advanced Delivery Systems (ADS) organization.
Compensation
The anticipated wage for this position is $141,000 - $231,000. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
Responsibilities
Serve as the technical lead and group leader for the separation science function within Analytical Development, defining and executing chemistry assay strategy and roadmap for RNA-LNP-based programs.
Lead end-to-end development, optimization, pre-qualification, and technical transfer of chemistry assays across separation platforms (e.g., IP-UPLC, RP-UPLC, CGE, LC-MS, SEC, SEC-MALS, IEX) to characterize and quantify mRNA, protein, and lipid components of drug product.
Represent the separation science function on cross-functional project teams and in technical review settings, and act as the primary analytical SME.
Ensure assay data, methods, and practices comply with ICH guidelines and industry best practices for cell and gene therapies.
Design, develop, and execute stability-indicating methods and forced-degradation studies to support product characterization, shelf-life determination, and ongoing stability programs.
Requirements
PhD in chemistry
PhD in biochemistry
MS in chemistry
MS in biochemistry
Senior Advisor, Separation Science — Analytical Development
Provide scientific leadership for analytical development supporting next-generation mRNA‑LNP‑based in vivo CAR‑T therapies within the Advanced Delivery Systems organization.
Compensation
$141,000 - $231,000
Responsibilities
Serve as the technical lead and group leader for the separation science function within Analytical Development, defining and executing chemistry assay strategy and roadmap for RNA‑LNP‑based programs.
Lead end‑to‑end development, optimization, pre‑qualification, and technical transfer of chemistry assays across separation platforms to characterize and quantify mRNA, protein, and lipid components of drug product.
Represent the separation science function on cross‑functional project teams and in technical review settings, and act as the primary analytical SME.
Ensure assay data, methods, and practices comply with ICH guidelines and industry best practices for cell and gene therapies.
Design, develop, and execute stability‑indicating methods and forced‑degradation studies to support product characterization, shelf‑life determination, and ongoing stability programs.
Senior Advisor, Separation Science — Analytical DevelopmentLilly · Boston, US