Director, Bioanalytical Sciences
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 Director, Bioanalytical Sciences to join our team.
Our 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 deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific technologies, and seven XmAb bispecific antibody programs 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 in the United States.
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.
Working within the Bioanalytical Sciences group of Xencor’s CMC Operations team, we seek an individual responsible for the development, qualification / validation and technical transfer of analytical methods used during biologics development and commercialization. The right candidate is a protein therapeutics technical expert and responsible for planning, designing, and executing analytical method life-cycle activities through multiple stages of development.
- Accountable for technical oversight and phase-appropriate development, qualification / validation, re-assessment, and transfer of chromatographic, electrophoretic, and immunological methods targeted for in-process, release, and stability testing of early and late stage protein therapeutic development programs.
- Internal expert on data interpretation, applications, instrumentation, and trouble
- Develops trending tools and tracks analytical method performance. Implements analytical method remediation measures, when required, from early data signals.
- Owns laboratory-related root cause analysis and unexpected results (OOS/OOT) investigation procedures. Implements and trains Xencor staff members on best practices.
- Maintains and initiates strong collaborations with contract testing laboratories.
- Advances analytical testing capabilities through CDMO and partner groups.
- Prepares and / or reviews documents in support of CMC regulatory submissions and writes responses to health authority questions.
- Works closely, as a multidisciplinary project team member, with internal and external collaborators.
- Provides expertise, technical leadership, and assessment of product quality impacting non-conformance and out of specification investigations.
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.
- Ph.D. in biochemistry, immunology, or related field with 8 years of relevant experience or M.S. with 12 years of relevant experience.
- Progressive experience in analytical / attribute sciences or product quality within the biopharmaceutical industry.
- Proven technical leader with direct analytical method development and validation experience.
- Understands and implements quality by design and design of experiments
- Promotes a quality culture throughout the organization.
- Strong understanding of drug development processes and related GMP global regulations.
- Strong knowledge of biologics characterization techniques.
- Experience with stability and comparability study design and implementation.
- Experience with analytical data analysis and statistical modeling.
- Experience with procedures leading to global regulatory approvals.
- Organized and detail-oriented.
- Excellent communication and presentation abilities.
- Proficiency with MS Office suite.
- Ability to travel up to 20% as needed.
- Experience working with partner companies or Contract Manufacturing Organizations.
- Experience leading project teams or managing direct reports.
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 performed in an office environment.
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
Americans with Disabilities Act (ADA) Statement
The 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 HR@xencor.com.
To 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 functions.
Equal Employment Opportunity (EEO) Statement
The 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 law.
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.