Principal Scientist- LCMS

Resolian Inc.; Malvern (Chester County); In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Resolian Inc. is seeking a Principal Scientist to lead the development, validation, and application of LC-MS quantitative bioanalytical methods for large molecule therapeutics, spanning preclinical and clinical programs.

You will mentor scientists, collaborate with clients, and shape scientific strategy while advancing LC-MS technologies, ensuring compliance with GLP and regulatory expectations.

Competenze

• Extensive GLP experience in method development and validation for large molecules.
• Proven expertise in hybrid ligand-binding assays and LC-MS quantitation.
• Hands-on experience with triple quadrupole platforms.
• Demonstrated leadership and scientist development.
• Experience presenting to clients and regulatory bodies.

Mansioni

• Lead development and GLP validation of LC-MS bioanalytical methods for preclinical and clinical programs.
• Mentor and train a team of scientists.
• Develop, optimize, troubleshoot, and interpret methods for large molecules.
• Direct client programs and advise on design and data interpretation.
• Advance LC-MS technologies and workflows and evaluate emerging capabilities.
• Collaborate with PM, operations, QA, and regulatory teams to execute studies.
• Author and review technical and regulatory documents and present findings.
• Represent the company with BD, clients, and in the scientific community.
• Provide scientific leadership and strategic thinking.
• Demonstrate analytical problem-solving and innovation.
• Foster client and cross-functional collaboration.
• Train and mentor scientific talent; lead a small team.
• Maintain clear written and verbal scientific communication.

Conoscenze

GLP experience

LBA and LC-MS knowledge

Triple quadrupole LC-MS

Leadership and mentorship

Client-facing skills

Regulatory knowledge (FDA/EMA/ICh)

Strumenti

Orbitrap

QTOF

Descrizione del lavoro

We are seeking a Principal Scientist to lead the development, validation, and application of LC-MS quantitative bioanalytical methods for large molecule therapeutics. This technical leader will direct complex programs, mentor scientists, advise clients, and support strategic growth.

The role supports nonclinical and clinical studies involving proteins, peptides, oligonucleotides, and drug conjugates.

Key Responsibilities

• Lead development and GLP validation of LC-MS quantitative bioanalytical methods for preclinical and clinical programs.
• Lead, mentor, and train a group of scientists that are interested in growing their expertise.
• Develop, optimize, troubleshoot, and interpret methods and data for large molecule therapeutics and biomarkers in biological matrices.
• Direct multiple client programs and advise on method design, strategy, and data interpretation.
• Advance LC-MS technologies, workflows, and automation and play a role in the evaluation of emerging capabilities.
• Partner with project management, laboratory operations, quality assurance, and regulatory teams to execute studies successfully.
• Author and review technical and regulatory documents and present findings to clients
• Represent the company and expertise with BD, clients and in the scientific community.
• Scientific leadership and strategic thinking
• Advanced analytical problem-solving and innovation
• Client and cross-functional collaboration
• Training, mentoring and scientific talent development with the ability to lead a small team of scientists
• Clear written and verbal scientific communication

Impact

The Principal Scientist will expand large molecule bioanalytical capabilities, shape scientific strategy, and drive technical excellence in support of next-generation therapeutics and organizational growth.

Qualifications

Required

• Extensive GLP experience developing and validating bioanalytical methods for oligonucleotides, proteins, or antibody-drug conjugates; expertise across multiple modalities is preferred.
• Knowledge of hybrid ligand-binding assay (LBA) and LC-MS approaches for large molecule quantitation.
• Hands‑on experience with triple quadrupole platforms and quantitative LC‑MS workflows.
• Demonstrated scientific program leadership team mentorship, and scientist development.
• Experience representing the scientific discipline with clients and in the scientific community.
• Strong knowledge of bioanalytical validation and relevant FDA, EMA, ICH, and M10 guidance, with excellent problem‑solving, communication, and client‑facing skills.

Preferred

• Experience with HRMS platforms such as Orbitrap or QTOF.
• Experience in a CRO or as a scientific expert in the pharmaceutical industry.

External scientific or client representation, supported by publications, conference presentations, client engagement, or technology development.