Relypsa And Ilypsa Inc. Work Values

Daily Duties at Relypsa And Ilypsa Inc.:

• Coordinated development activities at multiple vendor sites for a non-absorbed polymer intended to be used a potassium binder. Developed a new stabilizer which decreased a toxic byproduct generated in the API. Used new process to make >50 kilo batches of stable API at a vendor site for clinical trials and long term tox studies. • Worked closely with QA and Analytical at both Relypsa and the vendor to develop stability protocols and specifications for API. • Closely worked with Analytical and Formulation groups to develop methods for the analysis of intermediates and API and to develop appropriate formulations. • Involved with Discovery group in the selection and development of novel non-absorbed polymers intended to treat metabolic diseases. • Part of a team involved in submitting INDs. • Coordinated development activities for a nonabsorbed polymer intended to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. These included optimization of the process, identification of critical parameters for manufacturing API, strategic planning for API supply for clinical trials through NDA. Successfully manufactured several 500 kg batches of API for Phase III clinical studies at an external vendor site. Worked closely with Analytical, QA and Formulations group. • Led a team of scientists from cross-functional areas to manufacture a radio-labeled API, intended for human ADME studies, at an external vendor site. • Supervised and mentored a team of associates.

What they like about Relypsa And Ilypsa Inc.:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

process development, process research, scaleup, research, scientist, manufacture, process research and development, GMP, project leader, Managed CMOs, IND and NDA Filings, Bay Area, Associate Director, Senior Scientist, Los Angeles, San Diego, Senior Research Investigator, Senior Research Chemist

Skills

Sales Support, Software Implementation, Requirements Analysis & Specification, Problem Solving, GMP Regulations, Manage internal and external CMOs/CSOs, Project Leader, IND and NDA Filings, Chemistry Literature, Supervising People, Process Research and Development

These are some of the questions we asked our climbers about their experiences with Relypsa And Ilypsa Inc.: