JOB DESCRIPTION
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Job Title: Senior Scientist or Associate Principal Scientist, LCMS Platforms |
GLP Role: May serve as Principal Investigator |
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Segment: Bioanalysis & Biomarkers |
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Line of Business: Crystal Bio Solutions |
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Team: LCMS Bioanalysis & Biomarkers |
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Reports to: Director |
Location: Pleasanton, CA |
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Position Type: Full-Time |
Salary Range: $120,000-$165,000 |
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
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 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.
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.
Crystal Bio Solutions is an equal opportunity employer. We 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.
To apply, please email career_us@crystalpharmatech.com and include: