Scientist, Analytical Development

About the role

We are seeking a talented analytical scientist to lead analytical development and product characterization for monoclonal antibodies and other biologics produced using Neion Bio’s platform. This role involves working closely with process development scientists to develop and implement analytical strategies for characterizing product quality, guiding process development, and supporting regulatory submissions.

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

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

Why Neion Bio?

We are on a mission to reimagine the way complex biological molecules are produced to transform human health. At Neion Bio, you will play a pivotal role in an early-stage, fast-growing company, working alongside leading scientists and entrepreneurs. You will have substantial ownership over our analytical capabilities and product-development strategy, with the opportunity to participate in the company’s potential upside while having a significant impact on the world.

Pay

The expected base salary is $130,000–$170,000, depending on experience, with additional bonus compensation, equity compensation, and benefits.