- Boston, Massachusetts, United States
- Full-time · Senior
- $141K–$231K per year
- 4+ years
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