Principal Scientist, Quantitative Bioanalysis

Proclinical; Switzerland; On-site; CHF 107,000 - 148,000; Full time

Job summary

Proclinical is seeking a Principal Scientist to lead LC-MS-based quantitative bioanalysis programs for large molecule therapeutics. You will develop, validate, and apply bioanalytical methods in GLP environments, representing the company in client interactions.

Responsibilities include designing studies, overseeing method development, interpreting complex data for PK/TK and biomarker work, and collaborating with cross-functional teams to ensure project success and regulatory readiness.

Qualifications

• Extensive experience in development and validation of oligonucleotide, protein or ADC therapeutics for nonclinical and clinical bioanalysis in a GLP environment.
• Experience in a CRO environment or as a scientific expert in pharma.
• Knowledge of hybrid LBA and LC-MS approaches for large molecule quantitation.
• Hands-on experience with MS platforms and quantitative LC-MS workflows.
• Strong leadership of scientific programs and project management.
• Regulatory guidance knowledge (FDA, EMA, ICH, M10) for clinical bioanalysis.

Responsibilities

• Serve as a scientific leader for method development and validation of LC-MS-based quantitative bioanalysis programs for preclinical and clinical studies.
• Provide technical oversight and interpretation of complex bioanalytical data for PK, TK, and biomarker studies.
• Lead multiple client programs and act as scientific point of contact for study design and data interpretation.
• Drive innovation and implement advanced LC-MS technologies, workflows, and automation.
• Collaborate with project management, operations, QA, and regulatory teams to ensure study execution.
• Author and review study plans, validation protocols, reports, regulatory submissions and SOPs.
• Evaluate emerging technologies and contribute to expanding bioanalytical capabilities.
• Present findings to clients, senior leadership, and at external conferences.

Skills

LC-MS bioanalysis

Protein/ADC bioanalysis

GLP method validation

Client-facing leadership

Regulatory guidance (FDA/EMA/ICH)

High-resolution MS (HRMS)

Tools

Orbitrap

QTOF

Triple quadrupole MS

Job description

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.