Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including five programs currently in clinical testing with three more expected to start clinical testing by 1H2019 and have an excellent opportunity for a Director of Bioanalytical Sciences to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with eleven in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, MorphoSys, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
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 Director, Bioanalytical Sciences to be responsible for leading, managing, and conducting the bioanalytical support needs for projects. The position will lead the Bioanalytical Sciences function and oversee all analytical program activities for drug substance and drug product from candidate nomination to commercialization. The successful candidate will help drive CMC strategy and pharmaceutical development operations. The position will report to the Sr Dir Program Management and Manufacturing.
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 (virtual) 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 bioanalytical needs of clinical development projects; managing timelines and workflows effectively.
• Provide scientific insight into biologics 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 approaches to the development, evaluation, and negotiation with regulatory agencies of bioanalytical control strategies including specifications and stability.
• Perform other bioanalytical duties as assigned.
• Establishment and management of associated reference standards and reference materials.
• Adopting and driving innovative bioanalytical techniques and strategies that translate into robust commercial bioanalytical testing platforms.
• Recruit, develop, and mentor the bioanalytical team to meet current and future program, department, and individual goals.
• Ph.D. in (bio)chemistry or related field
• Minimum of 10 years of progressive leadership experience in bioanalytical 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 biologic characterization techniques
• Proven success with 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.
• Deep experience leading a bioanalytical development function with GMP responsibilities.
• Demonstration of driving bioanalytical innovation.
• Experience working with or for a Contract Manufacturing Organization (CMO)
• Previous experience managing direct reports
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 to firstname.lastname@example.org. For further information about Xencor, please visit our website at www.xencor.com EOE