Principal Scientist, LCMS

Mykelly; Malvern (Chester County); On-site; USD 140,000 - 150,000; Full time

Benefits offered by this job

Medical benefits

PTO & holidays

401K

Relocation assistance

Job summary

Kelly Science and Clinical is seeking a Principal Scientist in Malvern, PA to provide scientific leadership in LC-MS-based quantitative bioanalysis for large molecule therapeutics. The role emphasizes method development and validation for proteins, peptides, oligonucleotides, and ADCs, with HRMS expertise highly desirable.

You will lead complex projects, interact with clients, and guide scientific strategy across preclinical and clinical studies.

Qualifications

• PhD or equivalent with extensive experience in GA bioanalysis.
• Deep experience in development/validation of large molecule therapeutics for nonclinical/clinical bioanalysis.
• Knowledge of GLP guidance and regulatory expectations (FDA/EMA/ICh).
• Hands-on LC-MS workflows for large molecule quantitation.

Responsibilities

• Lead method development and validation projects for LC-MS-based bioanalysis.
• Oversee PK/TK and biomarker studies using quantitative LC-MS data.
• Manage multiple client programs and serve as scientific lead for study design and data interpretation.
• Drive adoption of advanced LC-MS technologies and automation strategies.
• Collaborate with cross-functional teams to ensure study execution and regulatory readiness.
• Contribute to scientific strategy and client interactions through publications and presentations.

Skills

Leadership

Project management

Client-facing

Bioanalytical expertise

Communication

Education

PhD in relevant field

MS in a related field (alternative)

Tools

LC-MS platforms

Triple quadrupole

HRMS (Orbitrap/QTOF)

Job description

Principal Scientist, LCMS Quantitative Bioanalysis

Kelly Science and Clinicalhas 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.

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