Manager, Quality Assurance Stability at Xencor

Pasadena, California, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Jun, 26

Salary

154000.0

Posted On

30 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Stability Program, SOPs, CMC-Analytical Team, Stability Protocols, Data Management, Shelf-Life Extension, cGMP, Regulatory Filings, Change Control, Corrective Actions, Metrics Reporting, Continuous Improvement, Project Management, Coaching, Supervision

Industry

Biotechnology

Description

Introduction: Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Manager, Quality Assurance, Stability to join our team. This is a hybrid position with 2 days a week onsite from our Pasadena, CA. location Summary: Responsible for contributing to the development, implementation and maintenance of Xencor’s Stability Program to ensure safety, efficacy, and quality of clinical products. Job Duties: Owns and governs product specific stability process from study design through reporting and lifecycle management Defines phase-appropriate, risk-based stability strategies aligned with development stage and business priorities Owns stability-related SOPs and templates (lean and fit-for-purpose) Acts as liaison with the CMC-analytical team to provide oversight of the stability protocols and data at the contract manufacturing/testing organizations in support of Xencor’s stability program Manages stability studies and data in the internal stability management software Provides user training and support for the stability program Enters stability data and manages the cross-functional review Contributes to the stability design and data gathering for shelf-life extension Manages the review and approval of various internal stability documents used in current Good Manufacturing Practices (cGMP) ensuring accuracy and appropriate format according to procedures Ensures out-of-trend or atypical results are addressed and support any on-going investigations Performs data verification for regulatory filings and other stability reports Participates in cross-functional project team meetings to provide stability updates as needed Supports activities for change control, corrective actions, management review and metrics reporting Identifies preventive action & continuous improvement opportunities Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements as applicable Adheres to all department and company-wide policies regarding conduct, performance, and procedures Provides oversight and direction to direct and indirect reports, as applicable (if assigned in the future), in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities Performs other duties as assigned. Education/Experience/Skills: Position requires a Bachelor’s degree in a scientific discipline, and at least 6 years of Quality Assurance experience in the biopharmaceutical industry with at least 1 year of stability program experience. Prior project management experience preferred. Position also requires: Ability to use written and verbal communication skills to communicate complex scientific, medical and program issues Ability to partner with cross-functional teams from research, pre-clinical development, manufacturing, quality, regulatory and clinical development Outstanding flexibility and adaptability suited for the changing requirements and fast pace of a small biotechnology company Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment. Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment. Expected Base Salary Range: $134,300 - $154,000 The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/. Americans with Disabilities Act (ADA) Statement The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Equal Employment Opportunity (EEO) Statement The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law. Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.

Responsibilities

The Manager, Quality Assurance Stability is responsible for developing, implementing, and maintaining the company's Stability Program to ensure the safety, efficacy, and quality of clinical products. This includes owning the product-specific stability process from study design through lifecycle management and acting as a liaison with the CMC-analytical team for oversight of stability protocols at contract organizations.