Proteomics Scientist: Regulatory Biotech Analytics

Cognizance Technologies, LLC; Silver Spring (MD); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health plan (PPO/HMO)

Job summary

Cognizance Technologies, LLC in Silver Spring, MD is seeking a Proteomics Scientist - Researcher to support FDA OPQR in advancing regulatory science. The role focuses on MS-based proteomics to detect and characterize host cell protein impurities in biosimilar and recombinant peptide drugs, aligning proteomics data with ELISA methods and contributing to risk assessment frameworks.

You will develop workflows for identification and quantification of HCPs, perform validation experiments with

Qualifications

• Demonstrated experience developing and applying mass spectrometry-based proteomics workflows.
• Experience with method bridging and comparability studies between proteomics and ELISA approaches.
• Knowledge of sample preparation for complex biopharmaceutical matrices (digestion, depletion, enrichment).
• Familiarity with immunogenicity risk assessment concepts and host cell protein impurities.

Responsibilities

• Develop, optimize, and apply MS-based proteomics workflows for HCP impurity identification and quantification.
• Conduct method bridging studies to compare proteomics data with ELISA results.
• Analyze HCP impurity profiles across biosimilar and recombinant samples.
• Perform orthogonal validation using LC-MS/MS, DIA, and related techniques.
• Develop sample preparation strategies to maximize HCP detection.

Skills

Mass spectrometry workflows

LC-MS/MS

DIA proteomics

Proteomics

Immunogenicity risk assessment

Regulatory science

Manuscripts writing

Cross-disciplinary collaboration

Data analysis

Education

Ph.D. or Master’s in analytical chemistry / proteomics

Tools

LC-MS/MS

Data-independent acquisition (DIA)

Job description

Cognizance Technologies, LLC in Silver Spring, MD is seeking a Proteomics Scientist - Researcher to support FDA OPQR in advancing regulatory science. The role focuses on MS-based proteomics to detect and characterize host cell protein impurities in biosimilar and recombinant peptide drugs, aligning proteomics data with ELISA methods and contributing to risk assessment frameworks.

You will develop workflows for identification and quantification of HCPs, perform validation experiments with