Proteomics Scientist - Researcher

Cognizance Technologies, LLC | Full time

Proteomics Scientist - Researcher

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

TheProteomics 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 andcharacterization 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 isperformed in FDA laboratories as assigned by the FDA Technical Point of Contact(TPOC).

Proteomics-Based Analytical Characterization of Host CellProteins

• 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 relevanttechniques, 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.

Immunogenicity Risk Assessment of HCP Impurities

• Identify andcharacterize HCPs with the potential to modulate immune responses, leveragingexisting databases, literature, and experimental data to prioritize HCPs ofregulatory concern.
• Collaborate with subjectmatter 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 relationshipbetween HCP impurity profiles detected by proteomics and immunogenicity risk,contributing to scientifically justified acceptance criteria for controllingHCP levels during biomanufacturing.

Regulatory Science Contributions

• Contribute to manuscriptdevelopment for publication in peer-reviewed scientific journals, communicatingresearch findings on proteomics-based HCP characterization and MS-basedimmunogenicity risk assessment.
• Support the developmentof 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 thedevelopment of training materials to educate quality assessors and regulatoryreviewers on proteomics-based HCP characterization concepts and theirregulatory implications.
• Translate researchfindings into practical regulatory tools.

Collaboration and Knowledge Transfer

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

Requirements

Required Knowledge, Skills, and Abilities

• Demonstrated experiencedeveloping 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 assessment concepts and the biological significance of hostcell protein impurities.
• Ability to collaborateeffectively with cross-disciplinary teams, including immunology subject matterexperts and regulatory reviewers.
• Strong scientificwriting skills, including experience contributing to peer-reviewed manuscripts,regulatory guidance documents, and training materials.
• Excellent written andoral communication skills, with the ability to translate complex analyticalconcepts for varied audiences.

Minimum Qualifications

• Ph.D. or master's degreein analytical chemistry, biochemistry, proteomics, mass spectrometry, or arelated life sciences field (equivalent experience may be considered).
• Prior laboratoryresearch experience in mass spectrometry-based proteomics, ideally within abiopharmaceutical, regulatory, or academic research setting.
• Experiencecharacterizing process-related impurities, host cell proteins, or relatedcritical quality attributes preferred.

• PPO/HMO Health Plan (includes medical, dental, and vision)