Manager, Quality Assurance Stability

Xencor•Pasadena, CA

3d•Hybrid

About The Position

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.

Requirements

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.
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.

Responsibilities

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.