Senior Scientist, LC-MS

Job Title

Senior Scientist or Associate Principal Scientist, LC-MS Platforms

Position Summary

A San Francisco based contract research organization (CRO) delivering globally recognized GLP/GCLP-compliant bioanalytical and biomarker services. We partner with multinational pharmaceutical and biotechnology companies to support their drug development programs.

The Bioanalysis & Biomarkers team specializes in method development, method validation, GLP/GCLP-compliant bioanalysis for pharmacokinetics (PK), and biomarker analysis. The group has a strong track record supporting non-GLP, GLP (non-clinical), and GCLP (clinical) studies.

This role is responsible for providing high-quality bioanalytical support across both preclinical and clinical programs while working closely with clients to ensure successful project execution and delivery.

Key Responsibilities

• Independently design assay strategies and develop, validate, execute, and troubleshoot LC-MS-based bioanalytical methods for:
• Small molecules and metabolites
• Biologics, including ADCs, monoclonal antibodies, proteins, peptides, and oligonucleotides
• Applications in PK and biomarker analysis
• Conduct or oversee GLP/GCLP-compliant sample analysis and data reporting
• Analyze, interpret, and present data to internal teams and external clients
• Serve as Principal Investigator (PI), managing client interactions throughout the study lifecycle, including:
• Study design
• Scheduling and execution
• Reporting and data transfer
• Ensuring timely delivery and overall client satisfaction
• Act as a Subject Matter Expert (SME) for LC-MS platforms
• Ensure full compliance with GLP/GCLP standards
• Author and/or review:
• Regulatory documentation
• Validation protocols and reports
• Laboratory data and technical reports
• Provide lab oversight, mentor junior team members, and contribute to continuous improvement initiatives
• Support the development and refinement of policies, procedures, work instructions, and SOPs
• Adhere to corporate standards related to:
• Code of conduct
• Environmental Health & Safety (EHS)
• GLP/GCP/GDP compliance
• Perform additional duties as required

Qualifications & Requirements

• Degree in Biology, Immunology, Chemistry, Pharmacology, or a related scientific discipline:
• PhD with 4+ years of experience
• Master's degree with 9+ years of experience
• Bachelor's degree with 12+ years of experience
  (Experience within CRO, pharmaceutical, or biotech environments required)
• Strong hands-on expertise in GLP/GCLP bioanalysis
• Proven experience developing and validating LC-MS methods for PK and/or biomarker applications
• Working knowledge of LIMS and QMS systems in a GLP/GCLP setting
• Demonstrated ability to independently deliver high-quality work on time
• Strong collaboration skills with colleagues, leadership, and clients
• Client-focused, detail-oriented, and committed to quality and compliance
• Excellent written and verbal communication skills

Preferred Qualifications

• Experience with large molecule LC-MS analysis (e.g., ADCs, monoclonal antibodies, proteins, peptides, oligonucleotides)
• Familiarity with additional bioanalytical platforms such as LBA, PCR, and flow cytometry
• Experience managing projects and supervising team members