Manager, Quality Control - Redwood City, CA | Biospace
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Manager, Quality Control

Relypsa Inc.

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Location:
Redwood City, CA
Posted Date:
6/14/2017
Position Type:
Full time
Job Code:
504
Salary:
DOE
Required Education:
Other
Areas of Expertise Desired:

Job Description

Company Overview

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.

Product Overview

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®.

Position Summary:  

The Manager will manage a small group of junior staff to coordinate activities such as method transfer between contract service providers and release of active pharmaceutical ingredient and commercial drug product.  Conduct metrics of findings and communicate to Contract Testing Laboratory (CTL) of findings.This position reports to a Director/Senior Director of Quality Control.

Position Responsibilities:

•   Write draft protocols and reports related to stability studies, qualification, transfers and validations.
•   Coordinate the raw data review to support release of commercial product.
•   Manage junior staff in the operations of a QC laboratory for conducting feasibility studies.
•   Manage review of data packages generated at CTLs, evaluate findings discovered during review and insure they are corrected. Communicate issues related to testing with Contract Service Providers (CSP) during teleconferences.  
•   Train and supervise other QC personnel internally or at the CTL in transferred methods. Provide necessary cross-training matrix.  Provide quality compliance of methods and equipment to ensure practice meets procedure.
•   Conduct or coordinate analytical method transfer for release and stability of drug substance and drug product as well as raw materials. Ability to troubleshoot method performance observed during method transfer.
•   Manage the investigation of out of specifications results by participating in the planning, execution, and report writing process of any investigation initiated internally or by contractors.

Requirements

Requirements:

•   Masters in a scientific discipline and 4-5 years related experience or comparable experience, or BS with at least 8 years of experience and relevant training.
•   At least 2 years of Quality Control experience.
•   Extensive knowledge and hands-on experience on chromatographic techniques. Prior experience releasing product in a QC environment under GMP regulations.
•   Excellent computer skills with knowledge of spreadsheet, word processing and database software.
•   Attention to detail as applied to data review; excellent analytical skills applied to investigations
•   Excellent protocol and report-writing skills. Experience with analytical method validation, validation principles and stability indicating properties

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.