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 s.briggs@proclinical.com.
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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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