Sr. Manager, CMC Project Management

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

This position can be based out of the San Diego or Monrovia, CA. locations and is a hybrid position with some days onsite.

 

Xencor is an innovative, clinical-stage biopharmaceutical 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 cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for a Sr. Manager, CMC Project Management to join our team.

 

Our protein engineering capabilities and the modular nature of our XmAb technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are advancing a deep clinical pipeline of novel drug candidates, including eight bispecific antibodies and two engineered cytokines, and more programs are expected to start clinical testing in 2022. We also leverage our many XmAb technologies by collaborating with leading global biopharmaceutical companies, including Genentech and Janssen Biotech, among others, and including our partnerships, 20 XmAb drug candidates are advancing through clinical development. Three XmAb medicines, to treat patients with a range of serious illnesses, such as aggressive lymphoma, rare blood disorders and COVID-19, are now marketed worldwide by partners.

 

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.

 

Summary:

Responsible for project planning and management with a focus on CMC Operations in support of product development.


Job Duties Include:

  • Create, track progress, and manage timelines, tasks and activities for multiple CMC/Operations projects
  • Works within the CMC function to help drive and deliver CMC/Operations output for product candidates
  • Review budgets, track and provide oversight for review and approval of documentation including manufacturing batch records, SOPs, Technical Reports, and investigations, etc.
  • Uses appropriate Project Management tools and methods to delivers high-quality and timely results
  • Supports CDMO change orders and invoicing
  • Develop and distribute periodic reports on performance, issues, risks, and schedule of key activities, events, or milestones
  • Serve as a CMC project contact with external and internal clients as needed
  • Participate in identifying, creating, and sustaining CMC processes in order to successfully support the growing pipeline of product candidates
  • Adhere to all department and company-wide policies regarding conduct, performance and procedures
  • Perform 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 8 years of related experience. Business knowledge of Biotechnology/Pharmaceutical manufacturing operations, product and process development and supply chain operations is also required.  An advanced degree

 

(MS, PhD) in engineering, life/physical sciences or other technical field of study or an MBA is preferred. At least 2 years of experience as a project manager required. Experience working with or for a Contract Manufacturing Organization (CMO) and with Drug Substance/Drug Product Manufacturing, Process Development, or other related functional areas within the Pharmaceutical/Biotech or Healthcare industry is preferred.  Certification as Project Management Professional is also preferred

 

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

 

Position also requires:

  • Demonstrated interpersonal skills to develop and maintain effective working relationships with internal and external stakeholders and cross-functional, cross-cultural project teams
  • Proven collaboration management, decision making skills and goal-orientation
  • 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

 


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 physical demands of the office 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 Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

 

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, including any boosters recommended by the CDC.  New employees will be required to provide proof of their fully COVID-19 vaccinated 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.

 

Thank You

Your application was submitted successfully.

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