An Assay Development Scientist creates assays or systems to test and evaluate the effect of a chemical compound on an organism. Directs assay development as part of a research process to develop new drugs.
Senior Scientist or Associate Principal Scientist, LCMS Platform Crystal Pharmatech Inc - 2.0 Pleasanton, CA Job Details Full-time $120,000 - $165,000 a year 10 hours ago Qualifications Pharmaceutical company experience Pharmaceutical analysis Liquid chromatography machines
Full Job Description 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.
