Group Leader/Associate Director, Bioassay Development

Bio-Analytical Development · Monrovia, California
Department Bio-Analytical Development
Employment Type Full Time
Minimum Experience Experienced

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 Group Leader/Associate Director 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.

 

We seek a Group Leader or Associate Director with expertise in the development, troubleshooting, and qualification/validation of cell-based bioassays and immunoassays. Title will be commensurate with qualifications, experience, and calibration. The incumbent will have expertise in developing functional cell-based assays for use in evaluating the relative potency of drug substance and drug product and/or the neutralizing capability of confirmed binding anti-drug antibodies in serum.

 

 

Job Duties Include:

 

  • Independently design, develop, optimize, qualify and/or validate and transfer novel cell-based bioassays and immunoassays for relative potency and neutralizing anti-drug antibody endpoints
  • Draft and review SOPs, technical reports, and regulatory documents
  • Supervise and mentor laboratory research associates and scientists
  • Represent the Bioanalytical Development function as a Product Team Representative (PTR) to matrixed drug development teams.
  • Transfer analytical methods internally or to contract laboratories; manage experiments and trend method performance and specifications
  • Lead bioassay comparability testing to support process changes and transfers.
  • Data review, approval, analysis, graphing, reporting and presentation to internal and external audiences, including regulatory agencies
  • Maintain current knowledge of the field and area(s) of scientific expertise and development
  • Assess method performance and identify issues and propose and implement appropriate remediation in conjunction with QA and company policies.
  • Familiarity with statistical concepts and design of experiments (DoE) related to functional cell-based assay development, optimization, and validation.

 

Qualifications/Requirements:

 

    • Ph.D. in Biochemistry, Cell Biology, or a related field with 5 or more years of experience in an industrial setting
    • Experience working in a regulated industry setting as a GXP contributing scientist
    • Extensive hands-on experience with the design, development, optimization, qualification and validation of novel bioassays and immunoassays across multiple platforms and technologies (e.g, ELISA, MSD, flow cytometry and cell based - proliferation, phosphorylation, reporter and cytotoxicity assays)
    • Knowledge of GxP as relevant to laboratory practices in sample handling and analysis of GLP, GCP, and/or GMP samples and specimens
    • Knowledge of industry guidances for the development, qualification/ validation of functional cell-based assays, GMP Potency methods, and/or neutralizing antibody assays.  
    • High competence in common software and data analysis packages (e.g., SoftMax Pro, GraphPad Prism, JMP, Microsoft Office tools)
    • Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well in a team

Physical Demands:

 

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

 

 

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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  • Location
    Monrovia, California
  • Department
    Bio-Analytical Development
  • Employment Type
    Full Time
  • Minimum Experience
    Experienced