Sr. Manager, Supply Chain

Sr. Manager, Supply Chain

Introduction:

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Senior Manager, Supply Chain to join our team.

This position will be based out of our San Diego, CA. location and required 2 days a week on-site.

Summary:

Responsible for managing procurement and distribution activities in support of Xencor clinical trials. 

Job Duties:

• Ensures all clinical trials receive timely and adequate supply for patients in support of Xencor clinical studies.
• Coordinate all Packaging and Labeling activities with Xencor approved facilities, including sourcing, contracting, production planning, and Batch Record review and release.
• Oversee and assists as necessary in distribution activities in support of clinical trials. 
• Oversee all logistics issues related to shipments to individual sites and to regional Depots as required.
• Support QA as needed in QP Release functions with scheduling and documentation as required.
• Oversee Depots, providing input as to locations, operations, and logistics in support of clinical trials.
• Partner with CMC, QA, RA, and clinical operations to ensure proper labeling strategy for IP, comparator, and combination drugs and provide input and/or samples as needed.
• Collaborate with CMC Drug Product and Supply Chain team regarding required CMC budgeting, timelines and/or similar matters to ensure a seamless flow of information and planning for the clinical study to the program level.
• Support Interactive Response Technology (IRT) selection and implementation for new studies; oversee maintenance of system to ensure proper utilization of Supply functions.
• Develop effective supply strategies maximizing available inventory by location and shelf life while minimizing waste and potential obsolescence.
• Manage sourcing strategy and tactical activities for comparator and combination drugs in support of Clinical studies.
• Lead risk mitigation through detailed insight of comparator and combination drug supply and demand issues for programs of strategic importance, cost, and/or constrained supply.
• Assist in development of clinical supply budgets and revisions as required.
• Adhere to all department and company-wide policies regarding conduct, performance, and procedures.
• Perform other duties as required

Education/Experience/Skills:

Position requires a Bachelor’s degree, preferably in Life Sciences, Business (Economics, Operations Management, Clinical Supply Chain Management, Clinical Trials Coordination) or Engineering; Advanced degree and APICS CPIM, CSCP certifications preferred.  Also requires 5-10 years of directly relevant work experience in clinical supply chain management forecasting and planning for clinical studies within Clinical Supply Chain, Clinical Operations, Planning, Manufacturing, Quality, or other Supply Chain disciplines, preferably in the Biotechnology/Pharmaceutical industry. Also requires prior people and project management experience for bulk drug products, IMP, comparators, and/or finished goods. 

The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.

Position also requires:

• Strong knowledge of supply chain processes including internal and external alignment (sourcing, manufacturing, quality, analytics, regulatory, finance, clinical operations)
• Working knowledge of cGMP’s as related to large molecule biopharmaceutical activities, familiar with US, EU, and global regulations applicable to investigational drugs and GCP regulations applicable to investigational product and supply
• Flexibility and willingness to adapt to changing business environment influences by developing and adopting new strategies and tactics. Ability to think strategically and translate into actionable plans.
• Strong ability to collaborate and build strategic and tactical relationships with internal (clinical operations, quality, regulatory, etc.) as well as external (CDMO, CPO, storage sites, etc.) stakeholders
• Strong budget management and financial analysis skills
• Ability to lead process improvement activities, delivering business processes and/or technical solutions satisfying multiple sets of stakeholders
• Strong planning, organization, and time-management skills to juggle needs of multiple teams and projects simultaneously
• Ability to demonstrate good judgment in determining objectives and approaches to assignments
• Excellent verbal/written communication and presentation skills, including ability to simplify what is complex and focus audience on key messages
• Strong computer (Excel, Word, PowerPoint, Visio) skills. Experience with Clinical Demand Planning and Inventory management systems.

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

Expected Base Salary Range:  $144,675 - $166,375

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits.  In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen.  New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

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.