Senior Scientist or Associate Principal Scientist, LCMS Platforms

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 establishing and 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.
Experienced with LCMS or tandem Mass-Spec method development and validation for PK and/or biomarker analysis
Experience with liquid handlers and other automation platforms for sample preparation and assay process
Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
Experience with Watson LIMS and in CRO environment is preferred.
Supervisory experience in both project and talent (people) management is preferred.
Ability to work independently and pay good attention to details.
Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.
Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
Effective writing and communication skills.