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 Associate Director or Director, Bioanalytical Sciences to join our team. Our capabilities and the modular nature of our technology allows 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. Five XmAb® bispecific antibody programs are in clinical testing, and two more are expected to start clinical testing in the first half of 2019. We also leverage our many XmAb® technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 12 XmAb® drug candidates through clinical development, and the first antibody that incorporates an XmAb® technology has been approved for commercial marketing in the United States.
This 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, and the ability to influence others. This includes the ability to effectively drive both internal and external (in partnership with contract development/manufacturing organizations) team discussions, through active engagement of multiple client relationships supporting various components of the product supply chain.
Job Duties include:
• Conduct and partner with vendors to support the analytical and bioanalytical needs of clinical development projects; managing timelines and workflows effectively.
• Provide scientific insight into biologics characterization
• Development of regulatory documents / Module 3 analytical content in collaboration with Regulatory Affairs CMC, serving as the analytical lead for associated regulatory interactions. Respond to analytical questions from regulatory agencies.
• Conduct and coordinate drug substance / 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 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 innovative analytical techniques and strategies that translate into robust commercial analytical testing platforms.
• Perform other analytical duties as assigned
• Ph.D. in (bio)chemistry or related field
• Minimum of 8 years of progressive experience in analytical sciences within the biopharmaceutical industry
• Strong understanding of drug development process and related regulations; including cGMP requirements
• Strong knowledge of biologics characterization techniques
• Experience with HPLC, Immunological, and MS techniques
• Experience with stability and comparability studies
• Experience with procedures leading to US and international regulatory approvals
• Organized and detail-oriented
• Excellent communication and presentation abilities
• Proficiency with MS Office suite
• Ability to travel up to 20% as needed
• Broad experience leading Analytical Development activities with GMP responsibilities
• Demonstration of driving analytical innovation
• Experience working with or for a Contract Manufacturing Organization (CMO)
• Previous experience leading project teams or managing direct reports