Principal Scientist, Quantitative Bioanalysis

Proclinical; Malvern (AR); On-site; USD 140,000 - 180,000; Full time

Job summary

Proclinical is seeking a Principal Scientist to lead LC-MS bioanalysis programmes in support of large molecule therapeutics. You will guide method development, validation in GLP environments, and interact with clients to shape study design and data interpretation.

The role requires leadership of multiple projects, strong communication skills, and a track record in PK/TK analyses and regulatory-aligned bioanalysis. Based in Malvern, PA with on-site work.

Qualifications

• Experience developing and validating bioanalytical methods for large molecules in GLP settings.
• Background in CROs or pharma with client-facing roles.
• Knowledge of LBA and LC-MS approaches for large molecule quantitation.
• Hands-on with triple quadrupole MS and quantitative LC-MS workflows.
• Capable of leading scientific programs and projects.
• Familiar with FDA/EMA/ICH biosample guidance for clinical bioanalysis.

Responsibilities

• Lead method development and validation for LC-MS bioanalysis in preclinical and clinical studies.
• Provide technical oversight and interpret complex bioanalytical data for PK/TK and biomarkers.
• Manage multiple client programs and act as scientific point of contact.
• Drive innovation in LC-MS technologies, workflows, and automation.
• Collaborate with PM, QA, and regulatory teams to ensure study success.
• Prepare study plans, validation protocols, reports, and regulatory submissions.
• Present findings to clients and at external conferences.

Skills

GLP bioanalysis

CRO/pharma experience

Hybrid LBA/LC-MS

Triple quadrupole LC-MS

Program leadership

Bioanalytical method development

Communication

HRMS platforms (Orbitrap/QTOF)

External representation of LC-MS

Tools

Orbitrap

QTOF

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.