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 Senior Manager will provide input to partner groups and senior management regarding activities needed for qualifying and maintaining secondary manufacturing sites (CMOs) and contract testing laboratories (CTLs). Will be responsible for efficient and compliant transfer of test methods for Relypsa materials between sites and review and troubleshooting of commercial testing and release of such materials. Will collaborate with other functional groups to ensure that commercial QC methods are current and appropriate. Reports to the Senior Director of Quality Control.
• Independently prepare method transfer, validation, equivalency and comparability protocols and reports at Relypsa and CTLs.
• Collaborate on implementation of appropriate methods for impurities and degradants using data resulting from spectral sources obtained at internal or external laboratories. Justify specifications for impurities and degradants and collaborate on reports summarizing related investigative studies.
• Prepare CMC documents for submission to US, EU and other regulatory agencies, including sections on impurities and characterization of reference standards.
• Address gaps encountered when reviewing raw data packages, conduct metrics and propose solutions to contract service providers to minimize recurrence of findings.
• Mentor and manage less experienced analysts in the group regarding current regulatory guidelines and their application to data integrity, method transfers, validations and characterizations.
• Propose experiments to determine the root cause of out of specifications results. Ability to conduct these experiments and/or assist on the execution of investigations at CTLs.
• Recommend analytical tests for qualifying reference standards and characterizing impurities. Ability to conduct these tests or outsource them.
• Ability to troubleshoot routine methods at CTLs and train analysts.
• Experience setting limits for drug substance attributes and independently writing justification of specifications documents.
• Position may include some travel (less than 10%).
• Master's degree and/or Ph.D. in Analytical Chemistry, Chemistry or related science preferred, or equivalent work experience
• 10 years of progressive responsibility in a GMP quality control (including commercial) environment
• At least two years of experience managing personnel in a quality control testing environment.
• Extensive expertise in a variety of analytical techniques including HPLC, IC, GC and spectroscopy to determine assay, purity and impurity profiles. Experience in the analysis of polymers a plus.
• Hands-on experience with method development, validation and transfer in support of pharmaceutical manufacturing.
• Able to influence other team members to collaborate solving problems and to communicate effectively across the company.
• Good working knowledge of German or French is desirable.
• Excellent written and oral communications skills.
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.