Associate Scientist II- Sr. Associate Scientist

Position Summary:

Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarkers. 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:

• Perform PK and Biomarker sample analysis using validated small molecule and hybrid LCMS assays with minimal supervision.
• Perform LCMS assay validation adherent to internal SOPs and ICH M10 standards.
• Manage validation and sample analysis activities using Watson LIMS.
• Support LCMS method development activities.
• Maintain GLP/GCLP compliance through all method validation and sample analysis activities.
• Independently operate Sciex Triple Quadrupole platforms.
• Recognize and resolve/escalate quality issues in LCMS data.
• Author reports encompassing the position’s laboratory responsibilities.
• Support qPCR, Flow Cytometry, LBA PK, and ADA efforts in other teams as needed.
• Perform other related duties as assigned

Qualifications & Educational Requirements:

• Bachelor’s degree in Analytical Chemistry, Biochemistry or other related scientific fields is required.

• A minimum of 1 year (Associate Scientist II) or 3 years (Sr. Associate Scientist) years of CRO/Pharma/Biotech experience.

• Experience with quantitative LCMS methodologies using Triple Quadrupole platforms.

• Hands-on experience in a GLP/GCLP regulated laboratory.

• Established record of independent objective achievement and adherence to timelines while maintaining high work quality.

• Effective in team environments co-workers, managers, and clients.

• Effective writing and communication skills, 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.

• 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.