Principal Scientist, Quantitative Bioanalysis
Confirmed on the employer's own hiring board on Oct 22, 2026. First seen by Alion on Oct 20, 2026.
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.
Primary Responsibilities:
The successful candidate will serve as a technical expert in mass spectrometry leading complex projects, representing the Company in client interactions and troubleshooting methods.
Skills & Requirements:
- 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.
The Principal Scientist's responsibilities will be:
- 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.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at [email protected].
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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