Principal Scientist, Quantitative Bioanalysis

Principal Scientist - Permanent - Malvern, PA

Ready to lead cutting-edge LC-MS bioanalysis programmes that accelerate the development of life-changing biologic therapies?

Proclinical is seeking a highly motivated and experienced Principal Scientist to provide scientific leadership in the development, validation, and application of LC-MS-based quantitative bioanalytical methods supporting large molecule therapeutics.

The successful candidate will serve as a technical expert in mass spectrometry leading complex projects, representing the Company in client interactions and troubleshooting methods.

• Extensive experience in development and validation of oligonucleotide, protein or antibody-drug conjugate (ADC) therapeutics for nonclinical and clinical bioanalysis in a GLP environment.
• Experience in a contract research organization (CRO) environment or as a scientific expert in pharma.
• Knowledge of hybrid ligand-binding assay (LBA) and LC-MS approaches for large molecule quantitation.
• Hands-on experience with triple quadrupole mass spectrometry platforms and quantitative LC-MS workflows.
• Proven ability to lead scientific programs.
• Strong knowledge of bioanalytical method development, validation, and regulatory guidance (FDA, EMA, ICH, M10) for supporting clinical bioanalysis programs.
• Excellent communication, problem-solving, and client-facing skills.
• Experience with high-resolution mass spectrometry (HRMS) platforms such as Orbitrap or QTOF systems.
• Experience with representing the LC-MS discipline to the external scientific community or clients.

• Serve as a scientific leader for method development and validation of LC-MS-based quantitative bioanalysis programs supporting preclinical and clinical studies.
• Experience in GLP method validation is a must.
• Design, develop, optimize, validate, and troubleshoot quantitative bioanalytical methods for large molecule therapeutics in biological matrices.
• Provide technical oversight and interpretation of complex bioanalytical data to support pharmacokinetic (PK), toxicokinetic (TK), and biomarker studies.
• Lead multiple client programs simultaneously and serve as a scientific point of contact for study design, strategy, and data interpretation.
• Drive innovation and implementation of advanced LC-MS technologies, workflows, and automation strategies.
• Collaborate cross-functionally with project management, laboratory operations, quality assurance, and regulatory teams to ensure successful study execution.
• Author and review study plans, validation protocols, reports, regulatory submissions, scientific publications, and standard operating procedures.
• Evaluate emerging technologies and contribute to strategic expansion of bioanalytical capabilities.
• Present scientific findings to clients, senior leadership, and at external scientific conferences.