The Associate Director is engaged in method development, qualification, conduct isolation and characterization of impurities. Support the manufacturing sites, contract testing laboratories and Relypsa partners with investigations and method implementation. Position reports to Executive Director AD and QC.
1.Plan, design and execute new analytical methods to support all aspects of drug development and manufacturing.
2.Provide analytical testing for manufacturing activities, test articles used in toxicology evaluations, process development activities, and clinical development activities. Write reports summarizing findings and critically review reports generated in Pharmaceutical Sciences.
3.Isolate impurities and degradants from drug substance and drug product using a variety of analytical techniques. Provide structures and recommends pathways of degradation or formation.
4.Conduct experiments in support of the characterization of reference standards, reference materials and reagents used for routine testing. Recommend appropriate tests to determine attributes such as purity, impurities and physical chemical properties.
5.Prepare or assist in CMC document preparation for regulatory (IND or NDA) submissions
6.Advice colleagues in areas related to analytical sciences.
7.Supervise staff of managers, scientists and associates by setting performance objectives, providing feedback and coaching staff engaged in analytical development projects.
8.Create and manage budgets related to equipment, and consumables. Develop and maintain a strategic plan for services that will be performed in-house vs. contracting with an outside vendor.
•Ph.D. or M.S. in Chemistry, or a related field or equivalent. A minimum of ten years of related experience in the bio/pharmaceutical industry and at least 5 years of management experience.
•Expertise and experience with analytical method development, qualification and validation for pharmaceutical products.
•Willingness to conduct bench work (20%)
•Extensive experience in analytical techniques including mass spectroscopy, HPLC, electrophoresis, bio-assays and spectroscopy to determine the purity and impurity profiles. Hands-on experience with method development, validation and transfer in a QC environment.
•Strong supervisory and project leadership experience desirable. Experience interacting with Regulatory agencies preferred.
•Familiarity with and understanding of cGMP guidelines.