Sr Scientist/ Associate Principal Scientist, LCMS Platforms

Crystal Pharmatech•Pleasanton, CA

6h•Onsite

About The Position

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.

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.

Nice To Haves

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.

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 analysis 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, including accurate documentation and adherence to established procedures
Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
Provide technical leadership for LC-MS as a Subject Matter Expert, and mentor junior scientists.
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