Contract Analytical Technical Manager Aegerion Pharmaceuticals, Inc.
THIS JOB HAS EXPIRED Position Description
We are seeking an accomplished analytical chemist with experience in small molecule API method development, validation, and transfer working with external manufacturing organizations. This is a 6 month contract position.
The major duties and responsibilities of the Contract Analytical Technical Manager, Pharmaceutical & Analytical Research and Development include, but are not limited to:
Provide effective technical and oversight for transfer of analytical methods to a CMO and oversee the execution of the transfer protocols at the transferring and receiving laboratories;
Oversee analytical development and testing activities at contract manufacturers and contract labs;
Up to 25% travel may be required;
Oversee any necessary analytical method development & validation for key intermediates, Drug Substance & Drug Product;
Ensure effective characterization of key intermediates;
Ensure effective design & execution of stability studies for DS & DP;
Provide QC support & data review;
Author and review of GMP- and ICH-compliant technical reports and Chemical Manufacturing and Controls (CMC) documentation required for regulatory submissions;
Actively participate in CMC Development Project Teams. Communicate with Chemical Development, Drug Product, Quality Control/Quality Assurance, and Regulatory Affairs to facilitate the development of candidate compounds and products.
Qualifications and Experience
Requires a minimum of a BS or MS and 6 to 12 years related pharmaceutical industry experience in the analytical development of small molecules.
More preferable a Ph.D. in Analytical, Organic or Pharmaceutical Chemistry.
Excellent verbal and written communication skills.
Expert knowledge of cGMP and ICH Regulatory Guidelines and country specific regulatory requirements and their application in analytical product development from IND to commercial stage.
Substantial knowledge of and experience with advanced analytical technologies and their application in pharmaceutical small molecule product development, incl. HPLC, GC, LC-MS and GC-MS, spectroscopic techniques, TGA and DSC.
Proficiency in all aspects of Microsoft applications (Excel, Word, Project, PowerPoint, etc.).
Proven ability to fulfill the overall role summarized above.
||Cambridge, MA |
THIS JOB HAS EXPIRED