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
• BA or BS degree in an engineering, chemistry or pharmaceutical science discipline, or comparable experience. An advanced degree in sciences would be a plus
• At least 10 years’ experience in Development and Commercial Pharmaceutical Products at operational and headquarters levels supporting manufacturing in a pharmaceutical or biotech environment
• Experience with all clinical phases and commercial drug product manufacturing required
• Prior experience related to managing external CMOs on a global basis
• Working knowledge of pharmaceutical cGMPs (US, EU, and ROW)
• Must understand standards of practice for manufacturing and supply chain operations
• Recent experience in leading cross-functional teams to accomplish Pharmaceutical Operations’ department goals
• Must have excellent communication skills (verbal, written, interpersonal, organizational), capable of setting priorities and managing high workload projects
• Position requires up to 20-30% travel
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Relypsa’s high regard for our employees.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.