Analytical Technical Manager Aegerion Pharmaceuticals, Inc.
THIS JOB HAS EXPIRED COMPANY BACKGROUND
Aegerion Pharmaceuticals, Inc. (NASDAQ: AEGR) is an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders. The Companys lead product, lomitapide, is in Phase III clinical development. Lomitapide is initially being developed to treat patients with a rare genetic lipid disorder called homozygous familial hypercholesterolemia, or HoFH. The Company also plans to initiate a clinical program for lomitapide to treat patients with a severe genetic form of hypertriglyceridemia called familial chylomicronemia (FC).
Analytical Technical Manager
We are seeking a highly motivated self-starter with proven leadership skills and extensive pharmaceutical experience in the analytical development of small molecule drugs from the early clinical phase to commercialization. The Analytical Technical Manager, Pharmaceutical & Analytical Research and Development will be a key member of highly competent cross-functional teams and will work directly with multiple contract manufacturers and contract labs in the US and Europe, as well as personally conduct and guide internal analytical activities.
Duties and Responsibilities:
The major duties and responsibilities of the Analytical Technical Manager, Pharmaceutical & Analytical Research and Development include, but are not limited to:
Provide effective technical and operational leadership and hands-on performance for the expedited analytical development of drug substance and drug product from IND to NDA/MAA, launch and beyond to meet the regulatory and business needs in context with the global development and commercialization.
Direct and oversee analytical development and testing activities at contract manufacturers and contract labs.
Up to 25 travel may be required, including international
Maintain effective coordination and on-time execution of complex analytical activities at multiple locations on the critical path to regulatory submissions and launch.
Perform analytical method development & validation for key intermediates, Drug Substance & Drug Product
Ensure effective characterization of key intermediates, DS & DP
Perform comparability assessment of key intermediates, DS & DP upon tech transfer, process improvement & scale-up
Ensure effective design & execution of stability studies for DS & DP
Lead effective specification development starting materials, chemical intermediates, DS & DP
Provide QC support & data review
Actively participate in CMC Development Project Teams. Communicate with Chemical Process Research and Development, Formulation Development, Quality Control/Quality Assurance, and Regulatory Affairs to facilitate the development of candidate compounds and products.
Lead the development and transfer to primary contract manufacturers of appropriate test procedures for chemical starting materials, chemical intermediates, drug substances and in-process controls.
Lead the development and transfer to secondary contract manufacturers of appropriate procedures for the assessment of the purity, potency and stability of drug product dosage forms.
Support the development of robust chemical and drug product processes and formulations.
Author and review of GMP- and ICH-compliant technical reports and Chemical Manufacturing and Controls (CMC) documentation required for regulatory submissions.
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.).
Attention to detail is essential.
Proven ability to fulfill the overall role summarized above
||Cambridge, MA |
THIS JOB HAS EXPIRED