Director, Manufacturing Strategies
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company. More information is available at www.relypsa.com.
Veltassa (patiromer) for oral suspension was approved in October 2015 for the treatment of hyperkalemia, a condition defined as elevated blood potassium levels that can cause abnormal heart rhythms and even sudden death. A potassium binder, Veltassa is the first new medicine for the treatment of hyperkalemia in more than 50 years and is the first commercialized medicine resulting from Relypsa s polymer technology platform. Relypsa is committed to ensuring that people living with the burden of hyperkalemia have access to Veltassa .
The Director of CMC Development and Manufacturing Strategies will report to the Vice President, CMC Development and Manufacturing Strategies. This position will provide guidance relating to the development and operational aspects of clinical and commercial manufacturing at contract manufacturers; lead overall manufacturing planning to support filing activities through registrational and validation batches; hand over manufacturing co-ordination to the Supply Chain group, and assist the VP CMC Development and Manufacturing Strategies in departmental requirements, including preparations of Pharmaceutical Operations budget, long range plans, and other project related activities.
Develop, establish plans and implement manufacturing of Relypsa products to support Relypsa s clinical and developmental programs, for both near and long-term timeframes
Assists with departments role leading manufacturing strategy for the Relypsa CMC team, which includes Quality Assurance, Analytical, Clinical, Technical Development groups and Management. Facilitate resolution of issues in a timely manner
Work directly with operating entities (internal and internationally based CMOs) to enable flexibility to meet the requirements of a multiple supplier qualifications, while remaining within the fiscal and timeline constraints
Support manufacturing Planning Analysis (Capacity and Capability Planning) for short and long range planning needs
Assist the department VP with the responsibilities such as environmental, customs, product launches, etc
Support the Pharmaceutical Operations group s efforts to incorporate system tools (i.e.: ERP, others) to facilitate the growth of the organization
Represent the department s perspective for Pharmaceutical Operations on cross functional project teams, manage implementation and adjusts plans as required