Associate Scientist II- Sr. Associate Scientist

CRYSTAL PHARMATECH INC; Pleasanton (CA); On-site; USD 80,000 - 95,000; Full time

Job summary

Crystal Bio Solutions in Pleasanton, CA is seeking a Bioanalysis professional to provide PK and biomarker support across pre-clinical and clinical projects. You will perform LCMS analyses, validate assays, and ensure GLP/GCLP compliance while collaborating with client teams.

You will operate Sciex Triple Quadrupole systems, generate reports, and assist in qPCR, Flow Cytometry, and ADA-related efforts as needed. A strong background in analytical chemistry and timely delivery is required.

Qualifications

• Bachelor’s degree in Analytical Chemistry, Biochemistry or related field.
• 1+ year CRO/Pharma/Biotech experience for Associate Scientist II, or 3+ years for Sr. Associate Scientist.
• Experience with quantitative LCMS methodologies using Triple Quadrupole platforms.
• Hands-on GLP/GCLP regulated laboratory experience.
• Strong writing and communication skills; ability to meet timelines.

Responsibilities

• Perform PK and Biomarker sample analysis using validated LCMS assays with minimal supervision.
• Validate LCMS assays per SOPs and ICH M10 standards.
• Manage validation and analysis activities using Watson LIMS.
• Maintain GLP/GCLP compliance across method validation and analysis.
• Operate Sciex Triple Quadrupole platforms independently.
• Identify and escalate data quality issues in LCMS results.
• Author reports covering laboratory responsibilities for projects.
• Support qPCR, Flow Cytometry, LBA PK, and ADA efforts as needed.

Skills

LCMS

GLP/GCLP experience

Team collaboration

Written communication

Education

Bachelor’s degree in Analytical Chemistry, Biochemistry or related field

Tools

Watson LIMS

QMS systems

Sciex Triple Quadrupole

PCR

Flow Cytometry

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

FullTime CA, Pleasanton, CA, US

2 days ago Requisition ID: 1002

Salary Range: $80,000.00 To $95,000.00 Annually

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.
• 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.