PK Bioanalysis Director

Role Summary

The Bioanalysis Director (BD) 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. Knowledge of anti-drug antibodies (ADA) assay 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.

Education

• BS degree in Chemistry or related field and a minimum of 13 years of relevant work experience; or,
• MS degree in Analytical Chemistry or related field and a minimum of 11 years of relevant work experience; or,
• PhD degree or equivalent in Analytical Chemistry or a related discipline and a minimum of 8 years of relevant work experience; or,
• Equivalent combination of education and experience.

Experience

• Experience/expertise in regulated bioanalysis and clinical-stage programs.
• Knowledge and experience in GLP/GCP requirements.
• Experience with LC-MSMS methods for small molecules, experience with ADA assays is a plus.
• Prior experience and good understanding of the regulatory requirement for method validation and sample analysis for PK and immunogenicity.
• Experience in managing CRO-outsourced bioanalysis.
• Experience with project management.

Knowledge, Skills And Abilities

• Applied knowledge and expertise with GLP and GCP regulations.
• High level of expertise in bioanalytical methods and technology platforms. Experience with LC-MSMS methods and immunoassays.
• Proficiency with Microsoft office software (Word, Excel, PowerPoint) and Watson LIMS.
• Detail-oriented, good organizational, documentation and technical writing skills.
• Able to work collaboratively with people from a broad range of business functions.
• Excellent interpersonal, organization and communication skills.
• Applies working knowledge of scientific, technical and quality management principles to solve problems (assays, processes, equipment, etc.).
• Work on a diverse scope of problems including scientific, technical and compliance.