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:
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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
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Serve as Subject Matter Expert (SME) for LCMS platform.
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Present and interpret data internally and/or externally as needed.
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Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
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Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
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Perform other related duties as assigned.
Qualifications & Educational Requirements:
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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.
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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.
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Established record of independent achievement of objectives and timelines while maintaining high work quality.
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Effective in team environments co-workers, managers, and clients.
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Must be goal-oriented, quality-conscientious, compliance-ensured, and client-focused.
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Effective writing and communication skills, preferred.
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Experience in GLP/GCLP LCMS method development and validation for PK and/or biomarker analysis is preferred .
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Functional experience utilizing LIMS and QMS systems for GLP/GCLP bioanalysis is preferred
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Familiarity with additional bioanalytical platforms (e.g. LBA, PCR, Flow Cytometry) is a plus.
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Supervisory experience in both project and talent (people) management is a plus.
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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.
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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.
