Proteomics Scientist - Researcher

Cognizance Technologies, LLC | Full time

Silver Spring, United States | Posted on 08/31/2026

The Proteomics Scientist supports FDA's Office of Pharmaceutical Quality Research(OPQR) in advancing regulatory science capabilities for the evaluation of biotechnology products. This position investigates the application of advanced mass spectrometry-based proteomics approaches for the detection and characterization of host cell protein (HCP) impurities in biosimilar andrecombinant peptide drug products, working to align proteomics data with traditional ELISA-based methods and to develop an evidence-based framework forimmunogenicity risk assessment of HCP impurities.

Laboratory research is performed in FDA laboratories as assigned by the FDA Technical Point of Contact(TPOC).

• Develop, optimize, andapply mass spectrometry-based proteomics workflows for the comprehensive identification and quantification of HCP impurities in biosimilar andrecombinant peptide drug samples.
• Conduct method bridging studies to compare and correlate proteomics-based HCP detection data with traditional ELISA-based HCP quantification results, establishing a scientific basis for use of proteomics approaches in regulatory submissions.
• Analyze HCP impurity profiles across a range of biosimilar and recombinant peptide drug product matrices, including samples derived from different host cell systems and biomanufacturing processes.
• Execute orthogonal validation experiments utilizing advanced analytical platforms, including LC-MS/MS, data-independent acquisition (DIA) proteomics, and other relevant techniques, to ensure the accuracy and reproducibility of HCP characterization data.
• Develop and optimize sample preparation strategies, including protein digestion, depletion, and enrichment workflows, to maximize HCP detection sensitivity in complex biopharmaceutical matrices.

• Identify and characterize HCPs with the potential to modulate immune responses, leveraging existing databases, literature, and experimental data to prioritize HCPs of regulatory concern.
• Collaborate with subject matter experts in immunology to evaluate the biological activity andimmunogenic potential of identified HCPs.
• Develop a systematic,evidence-based framework for risk stratification of HCP impurities based ontheir identity, abundance, and immunogenic potential.
• Assess the relationship between HCP impurity profiles detected by proteomics and immunogenicity risk,contributing to scientifically justified acceptance criteria for controllingHCP levels during biomanufacturing.

• Contribute to manuscript development for publication in peer-reviewed scientific journals, communicating research findings on proteomics-based HCP characterization and MS-basedimmunogenicity risk assessment.
• Support the development of regulatory guidance documents and best practices for the application ofproteomics-based approaches to HCP control in biosimilar and genericrecombinant peptide drug product development.
• Collaborate on the development of training materials to educate quality assessors and regulatory reviewers on proteomics-based HCP characterization concepts and their regulatory implications.
• Translate research findings into practical regulatory tools.

• Work with interdisciplinary teams across OPQR and CDER on collaborative regulatory science projects.
• Participate in scientific discussions and presentations of research findings.
• Communicate complex analytical concepts to internal and external audiences.

• Demonstrated experience developing and applying mass spectrometry-based proteomics workflows, including LC-MS/MS and data-independent acquisition (DIA) approaches.
• Experience with method bridging and comparability studies between proteomics-based and ELISA-based analytical approaches.
• Working knowledge ofsample preparation strategies for complex biopharmaceutical matrices, including protein digestion, depletion, and enrichment techniques.
• Familiarity withimmunogenicity risk…