PK Bioanalysis Director

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. They will possess strong technical expertise with LC-MSMS bioanalysis is essential.

Requirements

• 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.

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in first year
• 17 paid holidays including company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year