Principal Scientist, LCMS

Job Description

Job Description

Principal Scientist, LCMS Quantitative Bioanalysis
Kelly Science and Clinical has an opening for a Principal Scientist for an engagement at one of our leading pharmaceutical CRO clients in  Malvern, PA. The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, and 401K. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.  

Schedule : Mon-Fri, 8AM-5PM
Location : Malvern, PA
Duration : Direct Hire
Compensation : $140,000-$150,000
Relo support for non-local candidate

Position Summary
We are 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. This role will focus on method development and method validation for quantitative analysis of large molecule modalities supporting nonclinical and clinical studies.  Modalities include proteins, peptides, oligonucleotides, and drug conjugates. The successful candidate will serve as a technical expert in mass spectrometry leading complex projects, representing the Company in client interactions and troubleshooting methods. Additional expertise in  high-resolution mass spectrometry (HRMS) is highly desirable.

The Principal Scientist will play a critical role in expanding our large molecule bioanalytical capabilities and supporting the successful development of next-generation therapeutics, including biologics, oligonucleotides, and antibody-drug conjugates. This individual will contribute to scientific strategy, technical excellence, and the continued growth of the organization

Key Responsibilities

• 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.
• May have a small group of scientists reporting directly to this role for scientific training, mentorship and problem solving.

Qualifications
Required

• PhD with 10+yrs of experience, may consider MS with 15+yrs of experience
• Extensive experience in  development and validation of oligonucleotide, protein or antibody-drug conjugate (ADC) therapeutics for nonclinical and clinical bioanalysis in a GLP environment.  Deep experience in one of the listed areas is sufficient, but preference given for experience in more than one area.
• 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.

Preferred

• Experience with  high-resolution mass spectrometry (HRMS) platforms such as Orbitrap or QTOF systems.
• Experience in a contract research organization (CRO) environment or as a scientific expert in pharma.
• Experience with representing the LC-MS discipline to the external scientific community or clients.
• Track record of scientific publications, conference presentations, client interaction and engagement or technology development initiatives.
• Ability to mentor and develop scientist

P#1
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