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 and recombinant peptide drug products, working to align proteomics data with traditional ELISA-based methods and to develop an evidence-based framework for immunogenicity risk assessment of HCP impurities. Laboratory research is performed in FDA laboratories as assigned by the FDA Technical Point of Contact (TPOC).

Proteomics-Based Analytical Characterization of Host Cell Proteins

● Develop, optimize, and apply mass spectrometry-based proteomics workflows for the comprehensive identification and quantification of HCP impurities in biosimilar and recombinant 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.

Immunogenicity Risk Assessment of HCP Impurities

● 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 and immunogenic potential of identified HCPs.

● Develop a systematic, evidence-based framework for risk stratification of HCP impurities based on their 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 controlling HCP levels during biomanufacturing.

Regulatory Science Contributions

● Contribute to manuscript development for publication in peer-reviewed scientific journals, communicating research findings on proteomics-based HCP characterization and MS-based immunogenicity risk assessment.

● Support the development of regulatory guidance documents and best practices for the application of proteomics-based approaches to HCP control in biosimilar and generic recombinant 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.

Collaboration and Knowledge Transfer

● 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.

Requirements

● 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 of sample preparation strategies for complex biopharmaceutical matrices, including protein digestion, depletion, and enrichment techniques.

● Familiarity with immunogenicity risk assessment concepts and the biological significance of host cell protein impurities.

● Ability to collaborate effectively with cross-disciplinary teams, including immunology subject matter experts and regulatory reviewers.

● Strong scientific writing skills, including experience contributing to peer-reviewed manuscripts, regulatory guidance documents, and training materials.

● Excellent written and oral communication skills, with the ability to translate complex analytical concepts for varied audiences.

● Ph.D. or master's degree in analytical chemistry, biochemistry, proteomics, mass spectrometry, or a related life sciences field (equivalent experience may be considered).

● Prior laboratory research experience in mass spectrometry-based proteomics, ideally within a biopharmaceutical, regulatory, or academic research setting.

● Experience characterizing process-related impurities, host cell proteins, or related critical quality attributes preferred.

Benefits

• PPO/HMO Health Plan (includes medical, dental, and vision)
  
• 401K Retirement Plan
  
• Paid Time Off (PTO)