Director/Sr. Director, CMC Operations – Drug Product/Packaging and Labeling
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 Director/Sr. Director, CMC Operations – Drug Product/Packaging and Labeling to join our team.
Our 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 deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific technologies, and seven XmAb bispecific antibody programs 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 in the United States.
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.
The Director/Senior Director, CMC Operations is expected to provide leadership for the Drug Product and Packaging/Labeling manufacturing area. This includes driving strategy and managing requirements to deliver clinical supply for our pipeline programs. The position will oversee all Drug Product activities from pre-clinical to commercialization. The position will report to the Executive Director, CMC Operations.
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 relationships supporting various components of the product supply chain.
Job Duties include:
• Summary: Managing Drug Product/Packaging and Labeling contract site selection, cross-functional strategy with supply chain/clinical/quality/regulatory, group budget, contract site and staff performance, and managing communication/relationship with the contract site as well as internal management and managing direct reports.
• Identify, evaluate, and select appropriate contract sites to support production and testing. Develop robust business processes and maintain reliable relationships with contract site management. Assess industry trends, technology advancements, and contract site footprint.
• Manage budget development, monitoring, and reporting. Create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Process purchase orders and invoices. Actively manage and communicate forecasts to contract sites and manage capacity planning.
• Manage planning and coordination of product transfer to the contract site(s). Develop budget, timeline and coordinate transfer team activities to achieve seamless product transfer to the contract site(s). Drive risk management as part of transfer and lead site issue management and resolution; provide issue escalation to the right level.
• Track contract site performance and lead site operating review meetings. Drive improvements at contract sites.
• Deliver US/OUS product from contract site(s) that meet necessary quality, cost, and cycle time.
• Development of Module 3 Drug Product content in collaboration with Regulatory Affairs CMC, serving as the Drug Product lead for associated regulatory interactions.
• Experience needed in formulation and drug product development activities.
• Perform other US/OUS Drug Product and/or labeling and packaging duties as assigned.
• Recruit, develop, and mentor the Drug Product and labeling/packaging team to meet current and future program, department, and individual goals.
• Doctorate degree and 10 years of Biopharmaceutical manufacturing experience;
• Master’s degree and 12 years of Biopharmaceutical manufacturing experience;
• Bachelor’s degree and 15 years of Biopharmaceutical manufacturing experience
• Progressive leadership experience in manufacturing within the Biopharmaceutical industry
• Strong understanding of drug development process and related global regulations; including cGMP requirements
• Manufacturing experience with various types of drug product filling/packaging lines and container closure systems (i.e., vial, pre-filled syringe)
• Experience needed in Drug Product formulation development activities
• Experience with stability and Clinical In-Use compatibility studies
• 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 25% as needed.
• Master’s in Business Administration degree
• 20 years of experience in Biopharmaceutical (Drug Product) manufacturing environment
• 20 years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• 15 years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
• Experience managing multiple teams across broad portfolio
• Experience working with or for a Contract Manufacturing Organization (CMO)
• Previous experience managing direct reports
• Experience applying Six Sigma and/or Quality by Design principles, and process risk assessments
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.