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 Manager Quality Assurance Stability to join our is a hybrid position with 2 days a week onsite from our Pasadena CA. locationSummary: Responsible for contributing to the development implementation and maintenance of Xencors Stability Program to ensure safety efficacy and quality of clinical Duties:Owns and governs product specific stability process from study design through reporting and lifecycle managementDefines phase-appropriate risk-based stability strategies aligned with development stage and business prioritiesOwns 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 Xencors stability programManages 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 Contributes to the stability design and data gathering for shelf-life extensionManages 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 opportunitiesAssures 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 6 years of Quality Assurance experience in the biopharmaceutical industry with at least 1 year of stability program experience. Prior project management experience also requires:Ability 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: $134300 - $154000The 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.