Sr. Manager, Quality Assurance Stability

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 . We have an excellent opportunity for a Sr. Manager Quality Assurance Stability to join our is a hybrid position with2days a week onsite from our San Diego : The Senior Manager Quality Assurance Stability leads and executes endtoend productspecific stability programs across the lifecycle from study design and implementation through data management reporting and shelflife oversight. This role develops phaseappropriate riskbased stability strategies and works handson with crossfunctional partners and external CMOs/CTOs to design manage and oversee stability studies. The position analyzes and interprets stability data to establish or revise shelflife and retest periods authors stability assessments for global submissions and proactively identifies trends and risks to support CMC and regulatory Duties: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 updatesAuthors 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 stability studies and data in the internal stability management softwareProvides user training and support for the stability programEnters 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 proceduresEnsures out-of-trend or atypical results are addressed and support any on-going investigationsPerforms data verification for regulatory filings and other stability reportsParticipates in cross-functional project team meetings to provide stability updates as neededSupports activities for change control corrective actions management review and metrics reportingIdentifies preventive action & continuous improvement opportunitiesCreates and maintains stability SOPs to facilitate continuous improvement Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasksMaintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements as applicableAdheres to all department and company-wide policies regarding conduct performance and proceduresProvides oversight and direction to direct and indirect reports as applicable (if assigned in the future) in accordance with the organizations 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 opportunitiesPerforms other duties as assigned. Education/Experience/Skills:Position requires a Bachelors 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 also requires:Core statistical skills such as trend analysis and regression modeling confidence internals & variabilityAbility to use written and verbal communication skills to communicate complex scientific medical and program issuesAbility to partner with cross-functional teams from research pre-clinical development manufacturing quality regulatory and clinical developmentOutstanding flexibility and adaptability suited for the changing requirements and fast pace of a small biotechnology companyAbility to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelAbility to effectively manage others through coaching and supervision in accordance with company policies and practices. Ensures employee performance meets the organizations expectations for conduct productivity quality continuous improvement and goal travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $150000 - $175000The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe 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 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 Employment Opportunity (EEO) StatementThe 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 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.