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.
Competencies
- 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.
