Scientist, Analytical Development

Neion Bio, Inc.; New York (NY); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Job summary

Neion Bio, Inc. is seeking a talented analytical scientist to lead analytical development and product characterization for monoclonal antibodies and other biologics produced using Neion Bio’s platform.

You will develop and implement analytical strategies to characterize product quality, guide process development, and support comparability, technology transfer, and regulatory submissions across physicochemical, structural, and functional assays.

Qualifications

• 5+ years in analytical development or characterization of monoclonal antibodies or related biologics.
• Ph.D. in analytical chemistry, biochemistry, biophysics, pharmaceutical sciences, chemical engineering, or related field; or equivalent industry experience.
• Strong understanding of monoclonal antibody structure, function, degradation pathways, and key quality attributes.
• Hands-on experience with core analytical techniques listed above.
• Experience managing CROs or external laboratories and regulatory expectations (CMC/QA).

Responsibilities

• Develop and execute analytical strategies for monoclonal antibodies and other proteins from early development through clinical manufacturing.
• Characterize product quality, guide process development, and support comparability, technology transfer, and regulatory submissions.
• Develop, optimize, and perform in-house analytical methods for concentration, purity, aggregation, charge variants, identity, binding, and activity.
• Lead analytical characterization of critical quality attributes, including glycosylation, structure, purity, and binding assays.
• Design comparability studies of Neion-produced proteins vs references across process changes and sites.
• Select and manage CROs, draft scopes of work, and oversee study timelines and budgets.

Skills

Analytical development

Characterization

Biologics

Method development

Education

Ph.D. in analytical chemistry or related field

Tools

SEC-HPLC/UPLC

Ion-exchange

CE-SDS

LC-MS

ELISA

SPR/BLI

Job description

About Neion Bio

Neion Bio is harnessing nature’s best molecular factory, the chicken egg, to make medicine affordable, accessible, and resilient. We turn farms into medicine factories using cutting edge genetic engineering and stem cell technology. These “living bioreactors” are fully autonomous 3D biomolecular printers that operate on existing industrial-scale infrastructure. Our platform can rapidly and scalably produce almost any protein, provide national resilience to drug shortages and de-risk complex supply chains, and ultimately take advantage of novel biological environments to solve unmet medical needs. Biomanufacturing, reinvented. Medicine, democratized.

Role Summary

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.

Key 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

• 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

Compensation: base salary is expected to be $130-170K depending on experience, with additional bonus compensation, equity compensation and benefits including health insurance, dental insurance, vision insurance, and 401(k).