Senior Director, Bioanalytical Sciences

CMC Operations · Monrovia, California
Department CMC Operations
Employment Type Full Time
Minimum Experience Senior Manager/Supervisor

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 Senior Director, Bioanalytical Sciences

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.

 

This leadership position will interact with multiple levels of the organization.  Candidate must have the ability to approach issues from both a strategic and tactical perspective.  Additionally, the successful candidate must demonstrate business acumen, communication/presentation skills, exhibit leadership qualities, and the ability to influence others.  This includes the ability to effectively drive both internal and external (virtual) team discussions and decision-making supporting various components of the product supply chain. 

 

Job Duties include:

  • Work internally and partner with vendors to support the analytical and bioanalytical needs of pipeline projects; managing timelines and workflows effectively.
  • Provide scientific insight into biologic product characterization.
  • Development of Module 3 analytical content in collaboration with Regulatory Affairs CMC, serving as the analytical lead for associated regulatory interactions.
  • Conduct and coordinate API characterization, drug product characterization, and in-vitro testing as needed.
  • Participate in bioanalytical activities including managing the development, qualification, and validation of methods.
  • Drive innovative phase-appropriate approaches to the development, evaluation, and negotiation with regulatory agencies of analytical control strategies including specifications and stability.
  • Establishment and management of associated reference standards and reference materials.
  • Adopting and driving phase-appropriate innovative analytical techniques and strategies that can translate into robust commercial analytical testing platforms.
  • Perform other analytical duties as assigned.
  • Recruit, develop, and mentor the analytical team to meet current and future program, department, and individual goals.

 

Qualifications/Requirements:

  • Ph.D. in (bio)chemistry or related field
  • Minimum of 12 years of progressive leadership experience in analytical sciences within the biopharmaceutical industry
  • Strong understanding of drug development process and related regulations; including cGMP requirements
  • Experience with HPLC and MS techniques
  • Experience with stability and compatibility studies
  • Strong knowledge of biologics characterization techniques
  • Proven success with US and international regulatory approvals
  • Organized and detail-oriented
  • Excellent communication and presentation abilities
  • Extended experience leading an Analytical Development function with GMP responsibilities; direct reports
  • Proficiency with MS Office suite
  • Ability to travel up to 20% as needed

 

Preferred Qualifications:

  • Demonstration of driving analytical innovation
  • Experience working with or for a Contract Manufacturing Organization (CMO)

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  • Location
    Monrovia, California
  • Department
    CMC Operations
  • Employment Type
    Full Time
  • Minimum Experience
    Senior Manager/Supervisor