Senior Scientist or Associate Principal Scientist, LCMS Platform

Evolving Solution Services; Pleasanton (CA); On-site; USD 120,000 - 165,000; Full time

Job summary

Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker. Our clients include multinational pharmaceutical and biotech companies. The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, and biomarkers.

The team has 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

Qualifications

• PhD/MS/BA in analytical chemistry or related field with CRO/pharma/biotech experience.
• Expert LCMS method development and troubleshooting for small molecules and biologics.
• Experience with GLP/GCLP bioanalysis and PK/biomarker analysis is preferred.
• Strong written and verbal communication; ability to mentor staff.
• Familiarity with LIMS and QMS systems.

Responsibilities

• Independently design, develop, validate and troubleshoot LCMS-based bioanalytical methods for PK and biomarker measurement.
• Serve as SME for LCMS platform and present data internally/externally.
• Provide oversight of the laboratory, mentor junior staff, and drive operational excellence.
• Ensure compliance with EHS and GLP/GCLP standards.
• Support project work and client interactions as needed.

Skills

LCMS expertise

Bioanalysis

Leadership

Scientific communication

Education

PhD in Analytical Chemistry

MSc in Biochemistry

Bachelor's in related field

Tools

LIMS

QMS

GLP/GCLP compliance

Job description

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Senior Scientist or Associate Principal Scientist, LCMS Platform

FullTime Pleasanton, CA, US

7 days ago Requisition ID: 1001

Salary Range: $120,000.00 To $165,000.00 Annually

Position Summary:

Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker. Our clients include multinational pharmaceutical companies and biotech companies.

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
• Serve as Subject Matter Expert (SME) for LCMS platform.
• Present and interpret data internally and/or externally as needed.
• Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
• 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 Analytical Chemistry, Biochemistryor other related scientific fields required, including a minimum of 0 + (Ph.D.), 9 + (Master’s) or 12 + (Bachelor’s) years of CRO/Pharma/Biotech experience.
• Hands-on experience, strong expertise in LCMS method development and troubleshooting for small molecules and biologics (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) are required.
• 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, quality-conscientious, compliance-ensured, and client-focused.
• Effective writing and communication skills, preferred.
• Experience in GLP/GCLP LCMS method development and validation for PK and/or biomarker analysis is preferred .
• Functional experience utilizing LIMS and QMS systems for GLP/GCLP bioanalysis is preferred
• Familiarity with additional bioanalytical platforms (e.g. LBA, PCR, Flow Cytometry) is a plus.
• Supervisory experience in both project and talent (people) management is a plus.
• The salary range represents the anticipated base pay for this position. Actual compensation may vary based on factors including, but not limited to, skills, qualifications, experience, education, and location.
• As part of our recruitment process, we may use technology-assisted tools to support application review and improve efficiency. All hiring decisions are made by our team.