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Associate Director, Analytical Development - United States  

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Posted on : 19 June 2017

Project Description

Description:
  • 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.