Director, LCMS

Director, Large Molecule Bioanalysis (LC-MS)

Position Summary

Our client is seeking an experienced and strategic Director, Large Molecule Bioanalysis to lead bioanalytical activities supporting drug discovery and development programs. This individual will serve as a scientific leader responsible for advancing and implementing state-of-the-art LC-MS/MS-based bioanalytical strategies for the characterization and quantification of large molecule therapeutics.

The successful candidate will provide technical leadership across biologics programs, including monoclonal antibodies, antibody-drug conjugates (ADCs), bispecific antibodies, peptides, oligonucleotides, and other complex biologic modalities. This individual will work closely with interdisciplinary teams spanning DMPK, Translational Sciences, Toxicology, Pharmacology, and CMC to generate high-quality bioanalytical data that informs critical development decisions.

Key Responsibilities

• Lead the scientific strategy and execution of large molecule bioanalysis efforts across discovery and development-stage programs.
• Design, develop, qualify, and oversee LC-MS/MS assays for quantification and characterization of biologic therapeutics and biomarkers.
• Provide technical expertise in ligand-binding assays (LBAs), hybrid LBA-LC-MS approaches, and advanced mass spectrometry workflows.
• Oversee outsourced bioanalytical studies and manage CRO relationships to ensure delivery of high-quality, regulatory-compliant data.
• Support pharmacokinetic (PK), toxicokinetic (TK), biodistribution, and biomarker analyses for nonclinical and clinical programs.
• Drive innovation in mass spectrometry technologies and workflows to address complex bioanalytical challenges.
• Review, interpret, and present bioanalytical data to project teams, senior leadership, and external partners.
• Contribute to regulatory submissions and associated documentation, including INDs, investigator brochures, study reports, and responses to regulatory agencies.
• Collaborate closely with DMPK, Toxicology, Pharmacology, Translational Research, Clinical Pharmacology, and Regulatory Affairs teams.
• Build and mentor a high-performing bioanalytical team while fostering scientific excellence and innovation.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Mass Spectrometry, or related discipline.
• 10+ years of industry experience in bioanalysis, with significant experience supporting biologics and other large molecule therapeutics.
• Deep expertise in LC-MS/MS method development, validation, and application for large molecules.
• Strong understanding of biologic drug development, including antibodies, ADCs, peptides, protein therapeutics, and emerging modalities.
• Demonstrated success leading bioanalytical activities supporting nonclinical and/or clinical development programs.
• Experience managing external CROs and strategic partnerships.
• Working knowledge of regulatory requirements and bioanalytical method validation guidance.
• Proven ability to operate effectively in a fast-paced biotech environment.
• Excellent communication, leadership, and cross-functional collaboration skills.

Preferred Experience

• Experience supporting antibody-based therapeutics, bispecifics, ADCs, or oligonucleotide programs.
• Expertise in high-resolution mass spectrometry and advanced characterization techniques.
• Experience implementing hybrid bioanalytical platforms combining LC-MS and immunoassay approaches.
• Prior people leadership and team-building experience.
• Experience supporting regulatory filings and interactions with global health authorities.

Key Attributes

• Scientific leader with strong strategic and technical depth.
• Hands-on problem solver who enjoys tackling complex analytical challenges.
• Collaborative partner capable of influencing cross-functional teams.
• Passionate about advancing innovative therapeutic modalities through cutting-edge bioanalytical science.