Director, Analytical Science

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Job description

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 Director, 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 analytical methods performed at CDMOs and used during biologics development and manufacturing. Also responsible for planning, designing, and executing analytical method life-cycle activities through multiple stages of development.

Job Duties Include:

• Accountable for technical oversight and phase-appropriate development, qualification / validation, re-assessment, and transfer of chromatographic, electrophoretic, and immunological methods at/to CDMOs for the testing of in-process, release, and stability samples of early and late-stage protein therapeutic development programs
• Maintain and initiates strong collaborations with contract testing laboratories
• Track analytical method performance and implement analytical method remediation measures, when required, from early data signals
• Plan, design, and execute analytical method life-cycle activities through multiple stages of development
• Contribute expertise to stability study and comparability study design
• Contribute expertise on data interpretation, applications, instrumentation, and trouble shooting
• Provide expertise, technical leadership, and assessment of product quality impacting non-conformance and out of specification investigations
• Prepare and/or reviews documents in support of CMC regulatory submissions and draft responses to health authority questions
• Work closely, as a multidisciplinary project team member, with internal and external collaborators
• Adheres to all department and company-wide policies regarding conduct, performance and procedures Performs other duties as required

Education/Experience/Skills:

• Position requires an PhD in biochemistry, immunology, or related field and a minimum of 10 years of related, progressively responsible experience in analytical sciences within the biopharmaceutical industry.
• Experience working with partner companies or Contract Manufacturing Organizations and within a small biotech company environment required.
• Experience with stability and comparability study design and implementation, analytical data analysis and statistical modeling
• The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.

Position also requires:

• Promotion and support of a quality culture throughout the organization
• Strong understanding of drug development processes and related GMP global regulations
• Strong knowledge of biologics characterization techniques
• Strong organizational and attention to detail skills
• Excellent communication and presentation abilities
• Proficiency with MS Office suite
• Familiarity with Design of Experiments (DoE) approaches
• Ability to travel up to 10% by car and air
• 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 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 understand, remember and follow verbal and written instructions
  • Ability to maintain regular attendance and be punctual.

Working remotely all or part time is possible

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 .

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 .

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.

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