Associate Director, Analytical Development - United States
- This position is responsible for working collaboratively with cross-functional teams in support of drug development activities and is directly responsible for all aspects of analytical support for assigned projects.
- The individual collaborates with colleagues in Process Development, Formulation Development, Safety Assessment, Quality Assurance/Quality Control, and Regulatory Affairs to ensure high quality, on time delivery of CMC deliverables to ensure on-time progression of Pre-Clinical, Clinical and Commercial programs.
- Leads drug development Analytical activities to address key issues.
- Establishes external contracts with analytical CROs.
- Monitors, reviews and guides the analytical activities at these laboratories to ensure timely delivery of quality analytical work packages.
- Acts as a technical advisor on analytical techniques used for qualitative and quantitative analysis of drug substance.
- Directs and/or performs hands-on laboratory work to solve atypical technical issues as needed.
- Implement new and innovative analytical methods, and improves existing ones as needed.
- Assess stability data and propose shelf lives and retest dates that ensure the quality and safety of drug substances and drug products.
- Propose appropriate drug substance and drug product specifications based on batch data and regulatory expectations to ensure drug substance and drug product quality.
- Is experienced in GMP, Industry and Regulatory requirements.
- Writes and reviews technical documentation for regulatory submissions.
- Authors and reviews SOPs to ensure quality and compliance within CMC.
- Must have at least a MS or Ph.D. in analytical chemistry, organic chemistry, pharmaceutical sciences or other relevant field.
- Ten years of pharmaceutical R&D experience. Must have thorough knowledge of GMP, Industry, and Regulatory requirements.