Proteomics Scientist - Researcher

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 | 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)