Scientist, Analytical Development

Neion Bio•New York, NY

1d•$130,000 - $170,000

About The Position

We are looking for a talented analytical scientist to lead analytical development and product characterization for monoclonal antibodies and other biologics produced using Neion Bio’s platform. Working alongside our process development scientists, this individual will develop and implement analytical strategies to characterize product quality, guide process development, and support comparability, technology transfer, and regulatory submissions. The role will span physicochemical, structural, and functional characterization, including glycosylation, purity and aggregation, binding, and potency assays. The successful candidate will be responsible for in-house development and managing external programs.

Requirements

5+ years of industry experience in analytical development or characterization of monoclonal antibodies or closely related biologics
Ph.D. in analytical chemistry, biochemistry, biophysics, pharmaceutical sciences, chemical engineering, or a related field; or equivalent industry experience
Strong understanding of monoclonal antibody structure, function, degradation pathways, and critical quality attributes
Hands-on experience with several core analytical techniques, such as: SEC-HPLC or UPLC, Ion-exchange or other charge-variant methods, CE-SDS, capillary electrophoresis, or gel-based methods, LC-MS-based intact mass, peptide mapping, or glycan analysis, ELISA and other binding assays, SPR, BLI, or comparable biophysical binding methods
Experience developing, optimizing, qualifying, or transferring analytical methods
Experience managing CROs or external analytical laboratories, including defining study requirements, reviewing data, and troubleshooting technical issues
Familiarity with CMC regulatory expectations and experience with QA processes

Responsibilities

Develop and execute analytical strategies for monoclonal antibodies and other therapeutic and non-therapeutic proteins from early development through clinical manufacturing
Partner closely with process development scientists to characterize product and process-related variants, guide purification development, and establish relationships between process parameters and product quality
Develop, optimize, and perform selected analytical methods in-house, including assays for protein concentration, purity, aggregation, charge variants, identity, binding, and biological activity
Lead analytical characterization of critical quality attributes, including: Glycosylation and other post-translational modifications, Primary and higher-order structure, Purity, fragmentation, and aggregation, Charge heterogeneity, Target and Fc receptor binding, Cell-based potency and effector-function assays, including ADCC
Design analytical comparability studies evaluating Neion-produced proteins against reference products and across process changes, scales, and manufacturing sites
Select and manage CROs and specialized analytical laboratories, including drafting scopes of work, evaluating technical capabilities, managing timelines and budgets, and overseeing study execution