CMC Analytical Development Lead

Job description

Ref: MEC 213

 

The core purpose of the job is to manage the analytical development for various development projects.

As Lead analytical development CMC, you will be responsible for the analytical development strategy for drug substance and drug product and execution thereof for various development projects.

 

This includes

  •  Analytical method development and validation for drug substance and drug product analysis (non GMP and GMP)
  •  Stability studies and shelf life determination of drug substance and drug product (development and ICH studies), evaluation and characterization of impurities
  •  Specification development for drug substance and drug product
  •  preparation of analytical CMC source documents for clinical trial applications (quality section) and prepare responses to regulatory questions
  •  Selection and management of contractors executing the analytical development activities
  •  Collaboration with internal Quality and Compliance department to assure that CROs are performing according to cGMPs
  •  Interaction with other CMC team members (CMC Lead, Drug Substance Lead and Drug Product Lead) to build the CMC development plan and ensure execution thereof
  •  The analytical development lead shall decide on the CRO performing the analytical development activities and define the analytical development strategy.

Requirements

  • You have a Master degree-, or PhD in analytical chemistry, or pharmaceutical sciences, or Bio-engineering, or equivalent by experience .
  • You have a minimum of 5 year experience in drug development, especially in analytical development and are experienced in the preparation of analytical development reports for a number of IND/IMPD or NDA submissions.
  • You have exemplary teamwork and interpersonal skills, organizational and self-management skills, including planning and execution of meetings and presentations.
  • You have a good understanding of the drug development process, management of network of CRO’s, work in cross functional teams. You show proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.)