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Bioanalytical Scientist

San Diego, CA

Order: 65469

The Bioanalytical Scientist performs and interprets moderate and high complexity tests and reports results following standard operating procedures for patient specimens, proficiency samples, and quality control. You will also set-up and monitor testing at central laboratories.

Job Duties

  • Work on multiple projects and under strict timelines.

  • Provide analytical expertise for internal and external collaborators.

  • Manage the activities of external research laboratories or central laboratories contracted to conduct assay development or sample analysis.

  • Review external laboratory data, monitor assay performance and provide troubleshooting guidance.

  • 3rd party laboratory sample management and reconciliation.

  • Review technical documents including analytical method development reports, method validation protocols and reports and standard operating procedures in compliance with regulatory requirements.

  • Provide support for budgeting and invoicing for timely payments to vendors.

  • Authored and reviewed study protocols and manuals in support of Phase I and II oncology clinical trials in solid tumors.

  • Coordinated with Clinical Operations to manage clinical study specimens.

  • Create and maintain high quality compliance documentation for regulatory inspections.

  • Communicate with and manage CROs.

  • Perform all duties in keeping with Company’s core values, policies, and applicable regulations.

QUALIFICATIONS:

  • BS Degree (biology,chemistry, Biochemistry, Biophysics, Bioengineering, Chemical Engineering or related field)

  • 5 years of pharmaceutical/biotech experience, or Graduate Degree with at least 3 years of pharmaceutical/biotech experience

  • GXP experience required

  • Experience in multiple therapeutic areas, with prior experience in hepatology, gastrointestinal or related field, preferred