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 ofbiotechnology products. This position investigates the application of advancedmass 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 withtraditional 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 comprehensiveidentification and quantification of HCP impurities in biosimilar andrecombinant peptide drug samples.
• Conduct method bridgingstudies to compare and correlate proteomics-based HCP detection data withtraditional ELISA-based HCP quantification results, establishing a scientificbasis for use of proteomics approaches in regulatory submissions.
• Analyze HCP impurityprofiles across a range of biosimilar and recombinant peptide drug productmatrices, including samples derived from different host cell systems andbiomanufacturing processes.
• Execute orthogonalvalidation experiments utilizing advanced analytical platforms, includingLC-MS/MS, data-independent acquisition (DIA) proteomics, and other relevant techniques, to ensure the accuracy and reproducibility of HCP characterizationdata.
• Develop and optimizesample preparation strategies, including protein digestion, depletion, and enrichment workflows, to maximize HCP detection sensitivity in complexbiopharmaceutical matrices.

• Identify andcharacterize 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, communicatingresearch 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 regulatoryreviewers on proteomics-based HCP characterization concepts and theirregulatory implications.
• Translate research findings into practical regulatory tools.

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

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