Xencor is an innovative, clinical-stage biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Sr. Manager/Associate Director, Quality Assurance to join our team.
Our protein engineering capabilities and the modular nature of our technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are developing a broad portfolio enabled by the rapid expansion of our bispecific technologies, and nine XmAb bispecific antibodies and cytokines are in clinical testing. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. Including our partners, over a dozen XmAb drug candidates are advancing through clinical development, and the first antibody that incorporates an XmAb technology has been approved for commercial marketing worldwide.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
quality issues. Oversees the generation, review and/or disposition of internal and external documents used in GMP activities.
May conduct audits of US and EU contract manufacturing and labeling/packaging facilities.
The successful candidate is self-directed, detail-orientated, proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase company.
Job Duties include:
• Collaborates with CMO/CTOs and internal Xencor cross functional teams to enable compliant, successful technology transfers, operation and lifecycle management of cGMP clinical manufacturing and testing processes, ensuring product delivery schedules are met.
• Collaborates with CMC to support day to day GMP operations as needed
• Partners with contract manufacturing organization (CMO) to ensure compliant manufacture of products required for clinical and process validation supply.
• Act as the primary QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues.
• Partners with contract testing organization (CTO) to ensure compliant testing of products required for the release and stability of clinical material.
• Understand regulatory agency policies and guidance as it pertains to QA issues.
• Drives timely decisions and facilitates active communication and information flow between contract manufacturer and Xencor team members.
• Identifies and drives quality system process optimization initiatives and addresses opportunities for efficiency and capacity improvements.
• Advises on cross functional teams in problem solving and investigations that occur at the site
• Implements Xencor Quality requirements through review of documentation including batch records, deviations, CAPA, change controls and QC data in support of batch disposition
• Supports GMP inspections and audits from both regulatory authorities and collaborators
• Ensure integration of GMP batch disposition requirements between Xencor and CMOs
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
• Participate in Change Control, CAPA, and Deviation assessment and execution
• Follow up on CMO/CTO commitments to closure ensuring CMO/CTOs are accountable
• May conduct audits of US and EU contract manufacturing and labeling/packaging facilities.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• BS/BA degree in related discipline and minimum eleven (11) years of related QA experience; or,
• MS/MA degree in related discipline and minimum nine (9) years of related QA experience; or,
• PhD in related discipline and minimum seven (7) years of related QA experience, or;
• Equivalent combination of education and experience
• Experience in a clinical phase biologics
• Experience overseeing and partnering with Contract Manufacturing Organizations
• Direct experience participating and supporting regulatory inspections and submissions
• Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues (21 CFR part 11,210/211; Eudralex Volume 4, MHRA UK GMP, and ICH guidelines)
• Investigation and Root Cause Analysis training
Skills and Abilities:
• Demonstrate ability to be self-directed while managing multiple projects
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines with appropriate sense of urgency in a nimble fast paced matrixed environment
• Must be a strong team player with ability to collaborate cross functionally to develop, implement and deliver on goals
• Demonstrate excellent communication and interpersonal skills
• Adherence to high ethical and quality standards that focus on patient first values
• Must be able to work in controlled areas that may requiring special gowning
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is generally performed in an office environment, potentially some manufacturing and warehouse environment work.
Travel: Some travel is required (25%)
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at www.xencor.com EOE
Xencor 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.
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