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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• 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
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.