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Xencor

Director/Sr. Director, CMC Operations – Drug Substance

CMC Operations – Monrovia, California
Department CMC Operations
Employment Type Full Time
Minimum Experience Senior Manager/Supervisor

 

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 Substance (API) 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/Sr. Director of CMC Operations – Drug Substance is expected to provide leadership for the Drug Substance manufacturing area. This includes driving strategy and managing requirements to deliver Active Pharmaceutical Ingredient (API) for our pipeline programs. The position will oversee all Drug Substance 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 Substance 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 Drug Substance production at the contract site(s).

• Drive risk management for upstream and downstream processing 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 Substance content in collaboration with Regulatory Affairs CMC, serving as the Drug Substance lead for associated regulatory interactions.

• Experience needed in process development activities.

• Perform other US/OUS CMC Operations - Drug Substance duties as assigned.

• Recruit, develop, and mentor the CMC Operations - Drug Substance 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.

Requirements/Qualifications:

• 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 upstream and downstream processes

• Experience needed in disposable technologies

• Experience with stability and comparability 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

Preferred Qualifications:

• Master’s in Business Administration degree

• 20 years of experience in Biopharmaceutical (Drug Substance) 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

Physical Demands:

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.

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  • Location
    Monrovia, California
  • Department
    CMC Operations
  • Employment Type
    Full Time
  • Minimum Experience
    Senior Manager/Supervisor
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