Bioanalysis Director

The Bioanalysis Director will oversee GxP-compliance in bioanalytical work for pharmacokinetic (PK), anti-drug antibodies (ADA), and biomarkers in support of nonclinical and clinical studies. This role will manage CRO-outsourced bioanalysis for small molecules and biologics, as well as provide project management support for external and internal projects.

• Manage a GxP-compliant Bioanalytical Lab and support Lab Operations & Processes
• Lead GxP-compliance for PK, ADA, and biomarker bioanalysis for nonclinical and clinical trials
• Author and review standard operating procedures (SOP), qualification/validation protocols and bioanalytical reports
• Manage and oversee CRO-outsources bioanalysis of small molecules and antibody-drug candidates (ADCs)
• Serve as project manager for timelines and budgets in support of internal and outsourced projects

• BS degree in biological science or related field and a minimum of 13 years of relevant work experience
• Experience/expertise in regulated bioanalysis and clinical-stage programs
• Knowledge and experience in GLP/GCP requirements and practices in bioanalytical lab
• Experience with LCMS methods for small molecules and ADCs, experience with hybrid-LCMS is plus

Exelixis offers a comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Exelixis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.