Sr. Manager, Quality Assurance Stability

Xencor • Pasadena, CA

1d • $150,000 - $175,000 • 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 Sr. Manager, Quality Assurance Stability, to join our team.
This is a hybrid position with 2 days a week onsite from our San Diego, Ca. office
Summary:
The Senior Manager, Quality Assurance Stability leads and executes end‑to‑end, product‑specific stability programs across the lifecycle, from study design and implementation through data management, reporting, and shelf‑life oversight. This role develops phase‑appropriate, risk‑based stability strategies and works hands-on with cross‑functional partners and external CMOs/CTOs to design, manage, and oversee stability studies. The position analyzes and interprets stability data to establish or revise shelf‑life and retest periods, authors stability assessments for global submissions, and proactively identifies trends and risks to support CMC and regulatory strategies.

Requirements

• Position requires a Bachelor’s degree in a scientific discipline, and at least 10 years of Quality Assurance / QC / Analytical or CMC development experience in the biopharmaceutical industry with at least 4 years of stability program experience. Prior project management experience preferred.
• Core statistical skills such as trend analysis and regression modeling, confidence internals & variability
• 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.

Responsibilities

• Provides management and oversight of product-specific stability programs; from study design through reporting and lifecycle management
• Defines and drives phase-appropriate, risk-based stability strategies aligned with development milestones, regulatory expectations, and business objectives
• Collaborates with CMC Analytical Sciences, Drug Product/Drug Substance (DP/DS), Regulatory, Quality, and CTO/CMO partners to design stability studies and support shelf-life extension initiatives
• Analyzes and interprets stability data to establish or revise shelf-life and retest periods, proactively identifying trends and risks to inform CMC strategies and regulatory updates
• Authors stability assessments to support expiration dating, retest periods, and global regulatory submissions Manages and oversees stability tasks at Contract Testing Organizations (CTOs) and Contract Manufacturing Organizations (CMOs)
• Partners with the CMC-analytical team to provide technical oversight of the stability protocols and data at the contract manufacturing/testing organizations.
• 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
• 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
• Creates and maintains stability SOPs to facilitate continuous improvement
• 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.

Benefits

• 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/.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level