Staff to Senior Scientist, Analytical Development: XenoPort

We are current looking for an energetic and talented Analytical Chemist to join our Analytical Development group within Pharmaceutical Operations. The group is well equipped with advanced analytical instrumentation and techniques, such as HPLC, IC, dissolution apparatus, particle size analyzer, LC/MS/MS, GC/MS, NMR, as well as state-of-the-art data processing and management systems. This position will report to a group leader in the Analytical Development group within Analytical Chemistry.

• developing and validating GMP compatible analytical methods for API and drug product;
• performing sample analysis, preparing and reviewing related analytical documents in supporting chemistry and formulation development by following GMP and methods;
• evaluating physical and chemical properties for drug substances, including pH and solvent solubility, particle size, solid and solution stability, and solid state characterization;
• working on complex analytical and product development problems;
• reviewing protocols, laboratory data and reports from CMO/CRO;
• serving as an analytical liaison in inter-departmental project teams or in interaction with external CMO/CRO if needed;
• participating in preparation of CMC documents for regulatory filings; and
• maintaining familiarity with current regulatory guidelines.

Ph.D. in Analytical Chemistry (or equivalent) with zero to three years of working experience or MS degree in chemistry with five or more years of relevant experience in pharmaceutical analysis. Experience in GMP analytical method development/validation and/or ICH stability testing within the pharmaceutical industry. Experience with modern HPLC systems, data handling software and lab documentation. Capability of solving complex analytical problems in a dynamic work environment. Capability of working effectively in multi-disciplinary projects. Strong organization, communication and problem solving skills. Good record of research publication or report/document writing. Familiarity with physical chemical property characterization for API and drug product.