PK Bioanalysis Director
Exelixis
Full-time
Remote friendly (Alameda, CA)
United States
$163,000 - $232,000 USD yearly
Clinical Research and Development
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Role Summary
The Bioanalysis Director will manage outsourced regulated bioanalytical work for small molecules with LC-MS/MS in support of pharmacokinetic (PK) for nonclinical and clinical studies. Strong technical expertise in LC-MS/MS bioanalysis is essential; knowledge of anti-drug antibodies (ADA) assays is preferred.
Responsibilities
- Lead outsourced bioanalysis and work with CRO to establish robust bioanalytical methods to support PK assays for nonclinical studies and clinical trials.
- Review method validation and sample analysis plans, protocols, data and reports to ensure scientific integrity and compliance with regulatory requirements.
- Serve as project manager for timelines, contracts, and budgets in support of outsourced projects.
- Contribute to regulatory filings.
Qualifications
- Education: BS in Chemistry or related field with 13+ years of relevant experience; or MS in Analytical Chemistry or related field with 11+ years; or PhD in Analytical Chemistry or related field with 8+ years; or equivalent combination of education and experience.
- Experience: Regulated bioanalysis and clinical-stage programs; GLP/GCP knowledge; LC-MS/MS methods for small molecules; ADA assay experience is a plus; experience with regulatory requirements for method validation and PK immunogenicity; experience managing CRO-outsourced bioanalysis; project management experience.
Skills
- Applied knowledge of GLP and GCP regulations.
- Expertise in bioanalytical methods and technology platforms; LC-MS/MS and immunoassays experience.
- Proficiency with Microsoft Office and Watson LIMS.
- Detail-oriented with strong organizational, documentation and technical writing skills.
- Ability to collaborate with diverse business functions; strong interpersonal, organizational and communication skills.
- Problem-solving using scientific, technical, and quality management principles across assays, processes, and equipment.
Education
- As listed in Qualifications above (BS/MS/PhD in Chemistry or related field).
Additional Requirements
- No supervisory responsibilities.