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Associate Director, Analytical Development Wilmington United States,
Posted on : 19 June 2017
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. Responsibilities: 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. Minimum Requirements: 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.
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