Sr. Manager, CMC Operations

Sr. Manager, CMC Operations

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 Sr. Manager, CMC Operations to join our team.

This position is hybrid with 2 days a week onsite, from either our San Diego or Pasadena, Ca. office.

Summary:

Responsible for managing CMC Operations projects to meet ongoing production demands, ensuring uninterrupted drug substance development and manufacturing are executed in support of clinical needs.

Job Duties:

• Manages projects tasks and operations with PIP as needed
• Creates and manages timelines, reviews budgets, and approves documentation including manufacturing batch records, SOPs, Technical Reports, and Deviations 
• Works within CMC function to help drive and deliver CMC Operations output for product candidates
• Supports contracts, including negotiations for technology transfer, manufacturing and supply agreements
• Delivers high quality and timely deliverables via the use of appropriate PM tools and methodologies
• Develops and distributes periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones
• Serves as a CMC project contact with external and internal clients as needed
• Participates in identifying, creating, and sustaining CMC processes in order to successfully support the growing pipeline of product candidates
• Helps with authoring and reviewing CMC regulatory content in support of future and existing filings
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Capable of managing program inventory and supply chain activities
• Performs other duties as assigned.

Education/Experience/Skills:

Position requires a Bachelor’s degree in engineering, life/physical sciences or a related technical field of study, plus at least 8 years of related experience. Expertise in Biologics Drug Substance, Process Development or other related functional areas within the Pharmaceutical/Biotech or Healthcare industry also required. An advanced degree (MS) in engineering, life/physical sciences or other technical degree preferred. Prior experience as a CMC manager, experience and working with or for an External Mfg/Supply Chain/Contract Manufacturing Organization (CMO) is preferred

Position also requires:

• Strong interpersonal skills to develop and maintain effective working relationships with internal and external stakeholders and cross-functional, cross-cultural project teams
• Business knowledge of Biotechnology/Pharmaceutical manufacturing operations, product and process development and supply chain operations
• Strong collaboration management and decision-making skills
• Ability to communicate and/or present to all levels of staff and management
• Ability to tactfully and effectively negotiate and influence stakeholders
• Ability to manage multiple complex projects simultaneously while prioritizing individual and team efforts accordingly
• Proficiency in basic project management methodology and tools
• Strong attention to detail and analytical problem-solving skills
• Proficiency in MS office suite including Excel, Power Point, and Project
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model

Physical, Mental and Environment Demands:

The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The working environment for this role includes working in a research laboratory which may involve running experiments and operating laboratory scale process equipment for sample and data generation.  Occasionally, repetitive tasks, prolonged standing, and the use of PPE for handling hazardous and biohazardous materials may be required. See additional requirements for laboratory and research related jobs listed below.

The physical demands when working in the office environment are normally associated 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.

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

• Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
• Ability to work and sustain attention with distractions and/or interruptions.
• Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
• Ability to maintain regular attendance and be punctual.
• Ability to understand, remember and follow verbal and written instructions.

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: $161,000 - $180,000

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/.

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 [email protected].

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.