Sr. Scientist, LCMS Platforms

Calling LCMS experts! Kelly Scientific is partnering with a leading CRO in Pleasanton, CA seeking a Sr. Scientist or Associate Principal Scientist, LCMS Platforms to provide bioanalytical support for pre-clinical and clinical projects.

Job Title: Sr. Scientist or Associate Principal Scientist, LCMS Platforms

Location: Pleasanton, CA

Salary: $120,000-$165,000 Benefits

Position Summary

The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, and biomarkers. The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects and partnering with our clients for project success.

Key Responsibilities

• Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot LCMS-based bioanalytical methods for the quantification of small molecule (and its metabolites) and biologics (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) in support of PK, and Biomarker measurement
• Conduct or oversee GLP/GCLP sample testing and data reporting.
• Present and interpret data internally and/or externally as needed.
• Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
• Serve as Subject Matter Expert (SME) for LCMS platform.
• Ensure GLP/GCLP compliance
• Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
• Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
• Assist in establishing and improving policies, procedures, work instructions and SOPs.
• Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
• Perform other related duties as assigned.

Qualifications & Educational Requirements

• Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4 (Ph.D.), 9 (Master’s) or 12 (Bachelor’s) years of CRO/Pharma/Biotech experience.
• Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
• Experienced with GLP/GCLP LCMS method development and validation for PK and/or biomarker analysis.
• Functional experience utilizing LIMS and QMS systems for GLP/GCLP bioanalysis.
• Established record of independent achievement of objectives and timelines while maintaining high work quality.
• Effective in team environments co-workers, managers, and clients.
• Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
• Effective writing and communication skills are required.
• Experience in large molecule LCMS analysis (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) preferred.
• Familiarity with additional bioanalytical platforms (e.g. LBA, PCR, Flow Cytometry) preferred.
• Supervisory experience in both project and talent (people) management is preferred.

Customer is an equal opportunity employer. They are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, or any other protected status in accordance with applicable laws.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.