Lead LC-MS Quantitative Bioanalysis Scientist

Proclinical

Switzerland

On-site

CHF 107,000 - 148,000

Full time

2 days ago
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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

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.

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