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
FAQs
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