Director, Analytical Sciences

Director, Analytical Sciences

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 www.xencor.com. We have an excellent opportunity for a Director of Analytical Science to join our team.

This position can be based out of our San Diego or Pasadena, CA office and is a hybrid position.

Summary:

Responsible for the development, qualification/validation and technical transfer of analytical methods used during biologics development and commercialization.

Job Duties Include:

• Plans, designs, and executes 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 
• Contributes expertise on data interpretation, applications, instrumentation, and trouble shooting 
• Tracks analytical method performance and implements analytical method remediation measures, when required, from early data signals
• Support laboratory-related root cause analysis and unexpected results (OOS/OOT) investigations
• Contributes expertise to stability study and comparability study design
• 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 filings and writes responses to health authority questions
• Works closely  with internal and external collaborators
• Provides expertise, technical leadership, and assessment of product quality impacting non-conformance and out of specification investigations
• Implements quality by design and design of experiments
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable, 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 required

Education/Experience/Skills:

Position requires a Bachelor’s in biochemistry, immunology, or related field and a minimum of 12 years of related, progressively responsible experience in analytical development in the biopharmaceutical industry. A Master’s degree with 10 years of experience or a PhD with 8 years preferred.  Requires experience working with partner companies or Contract Manufacturing Organizations and experience with validation and direct analytical method development, stability, and analytical data analysis. Also requires statistical modeling, comparability study design and implementation and procedures leading to global regulatory approvals and analytical development or product quality within the biopharmaceutical industry. Previous experience working within a small biotech company environment is preferred.

Position also requires:

• Promotion and support of quality culture throughout the organization
• Strong understanding of drug development processes and related GMP global regulations
• Strong knowledge of biologics characterization techniques
• Strong organizational skills and attention to detail
• Excellent communication and presentation abilities
• Proficiency with MS Office suite
• Ability to travel up to 20% by car and air
• Ability to eliminate inefficiency and drive innovation
• 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.

Physical, Mental and Environment Demands:

The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The working environment for this role may include working in a research laboratory which may involve running experiments and operating laboratory scale process equipment for sample and data generation.  Occasionally, repetitive tasks, prolonged standing, and the use of PPE for handling hazardous and biohazardous materials may be required.  See additional requirements for laboratory and research related jobs listed below.

The physical demands when working in the office environment are normally associated 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.

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

• Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
• Ability to work and sustain attention with distractions and/or interruptions.
• Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
• Ability to maintain regular attendance and be punctual.
• Ability to understand, remember and follow verbal and written instructions.

Additional Requirements for Laboratory and Research Related Jobs

This role may involve work with experimental subjects and/or specimens including infected samples, plus various Hazardous Materials and infectious agents (Bloodborne Pathogens, or other potentially infections materials (OPIMs). Therefore, the following are also required:

• Ability to follow the established Environmental Health & Safety rules, procedures, and/or BioSafety Guidelines
• Ability to read and understand Safety Data Sheets (SDSs)
• Ability to be available and willing to work some weekends and evenings to conduct and complete experiments
• Knowledge of biosafety techniques and aseptic/gowning practices
• Experience with laboratory safety standards and procedures, including biohazard handling and disposal techniques, and the ability to ensure laboratory compliance with required safety regulations
• Experience working with biological and chemical hazards, infectious agents, bloodborne pathogens and animal allergens
• Experience working in and maintaining a sterile environment
• Experience working with chemical, and biological hazards 
• Thorough knowledge of the operation and maintenance of various lab equipment such as microscopes, centrifuges, spectrophotometers, balances, pH meters, and electrophoresis equipment, freezers, and incubators.

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.

Expected Base Salary Range:  $199,500 - $230,000

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. 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/.

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen.  New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.

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.