Xencor · 4 hours ago
Manager, Quality Assurance Stability
Pasadena, CA
Full-time
Hybrid
Mid, Senior Level
$134K/yr - $154K/yr
6+ years expXencor is a public, clinical-stage biopharmaceutical company focused on developing high-potential XmAb® bispecific T-cell engagers and engineered drug candidates. The Manager, Quality Assurance, Stability will be responsible for the development, implementation, and maintenance of Xencor’s Stability Program to ensure the safety, efficacy, and quality of clinical products.
BiotechnologyHealth CareTherapeutics
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
Qualification
Required
Bachelor's degree in a scientific discipline
At least 6 years of Quality Assurance experience in the biopharmaceutical industry
At least 1 year of stability program experience
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
Preferred
Prior project management experience
Benefits
401k match
Healthcare coverage
ESPP
Annual bonus
Equity grant
Company
Xencor
Xencor develops superior monoclonal antibody therapeutics to treat autoimmune disorders, asthma, allergic diseases and cancer.
201-500 employees
H1B Sponsorship
Xencor has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$683.9MKey Investors
Zen InvestmentsStafford Capital Partners
2024-09-11Post Ipo Equity· $201.3M
2021-11-19Post Ipo Equity· $25M
2018-03-19Post Ipo Equity· $226.3M
Leadership Team
Bassil Dahiyat
CEO
B
Bart Cornelissen
Chief Financial Officer
Recent News
Los Angeles Business Journal
2026-01-13
2026-01-09
2025-12-18
Company data provided by crunchbase