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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 developing and implementing analytical strategies to characterize product quality, guide process development, and support 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, post-translational modifications, structure, purity, fragmentation, aggregation, charge heterogeneity, binding, and cell-based potency assays
- 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
- 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, charge-variant methods, CE-SDS or other electrophoresis methods, LC-MS-based analysis, ELISA, and 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
Skills
- Analytical development
- Product characterization
- Monoclonal antibodies
- Biologics
- Physicochemical characterization
- Structural characterization
- Functional characterization
- Glycosylation analysis
- Purity analysis
- Aggregation analysis
- Binding assays
- Potency assays
- Process development
- SEC-HPLC
- UPLC
- Ion-exchange chromatography
- Capillary electrophoresis
- LC-MS
- ELISA
- SPR
- BLI
- Method development
- Method optimization
- Method qualification
- Method transfer
- CRO management
- Regulatory submissions
- CMC
- QA processes
Location
- Remote
Work Type
- Full-time
Experience Level
- 5+ years of industry experience
Education Level
- Ph.D. in analytical chemistry, biochemistry, biophysics, pharmaceutical sciences, chemical engineering, or a related field; or equivalent industry experience
Salary/Compensations
- $130-170K
Benefits
- Bonus compensation
- Equity compensation
- Health insurance
- Dental insurance
- Vision insurance
- 401(k)
About the Company
- 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.