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Principal Scientist-Bioanalysis

Prellis Biologics - Berkeley, CA, United States - In-office

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Prellis Biologics is seeking a Principal Scientist in Bioanalysis to join the Protein Sciences group. The role focuses on developing and executing bioanalytical assays that support molecular characterization, pharmacokinetics/pharmacodynamics (PK/PD), and preclinical development of next-generation biologic candidates, including antibody-peptide conjugates, bispecific/multispecific antibodies, and Fc-fusion proteins. Key responsibilities include leading bioanalytical method development using ELISA/LBA, LC-MS, and HRMS assays to characterize and quantify complex biologic modalities from discovery through preclinical stages. You will analyze serum/plasma samples, distinguish intact conjugates from free components and degradation products, and support candidate selection with rigorous analytical data. The position bridges Protein Sciences, Analytical Development, DMPK, CMC, and Pharmacology teams. Specific duties encompass developing and optimizing assays for novel antibody formats, selecting appropriate ligand-binding and mass spectrometry approaches, executing ELISA/LBA and LC-MS/HRMS-based assays, analyzing preclinical and in vivo study samples, characterizing biologic integrity and stability, supporting assay qualification and validation, and collaborating cross-functionally with protein engineering, CMC, analytical development, and pharmacology teams. You will also partner with the High Throughput Discovery group on early bioanalytical support for lead candidates transitioning from discovery to development, support external CROs and analytical vendors, deploy automated workflows on liquid handlers, and establish assay handoff workflows to enable seamless candidate progression. Required qualifications include a Ph.D. or M.S. in Bioanalytical Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field, with 3–6 years of direct relevant industry experience (or PhD with 0–3 years for Scientist level). Hands-on experience with bioanalytical assay development for biologics, antibodies, peptides, or proteins is essential. Proficiency with ELISA/LBA, LC-MS/MS, LC-HRMS, mass spectrometry platforms (e.g., Sciex Triple Quad), and ligand-binding assay platforms (e.g., MSD) is required. Strong understanding of protein/antibody characterization, data interpretation, and proficiency with data analysis software (Skyline, Analyst) are critical. Working knowledge of upstream antibody discovery workflows and ability to design bioanalytical methods matching discovery pipeline formats and throughput are expected. Bonus qualifications include experience with bispecific/multispecific antibodies, antibody conjugates, Fc-fusion proteins, novel modalities (ADCs, bispecific ADCs, radioconjugates, protein degraders), ICH guidelines, bioanalytical method validation, regulatory expectations, GLP/GCP experience, IND/CTA submissions, cross-functional communication, bridging discovery and preclinical bioanalysis, automation for bioanalytical workflows, and programming for data analysis (Python, R) or statistical modeling for PK.

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