Technical Writer

Toxicology · Monrovia, California
Department Toxicology
Employment Type Full Time
Minimum Experience Mid-level

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 Technical Writer to join our team.

 

Our protein engineering 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 broad portfolio enabled by the rapid expansion of our bispecific technologies, and nine XmAb bispecific antibodies and cytokines 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 worldwide.

 

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.

 

Xencor seeks a Technical Writer for its Monrovia office. 

 

Job Duties include:

  • Preclinical Technical Writing and Project Management: Manage contributing scientist teams in the generation of Research Technical Reports needed to support regulatory filings;
  • Draft, edit or proofread Technical Reports and Regulatory Documents; and Review and edit technical documents from CROs and consultants
  • Quality Control Technical Writing: Draft, edit, or proofread Analytical Methods (AM), AM Qualification and Validation Plans and Reports, and Standard Operation Procedures, in collaboration with contributing scientists
  • Technical Investigations Writer (deviations, change controls, CAPAs)
  • Document Control Manager: Establish and maintain document templates
  • SOP lifecycle management
  • Report lifecycle management
  • Centralized document control manager in Veeva Vault systems
  • Initiates and supports continuous improvement initiatives
  • Maintain current knowledge of the field and area(s) of technical expertise and development
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors; and Performs other related duties and responsibilities, on occasion, as assigned. 

 

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:

Position requires a bachelor’s degree in communications, marketing, biology or related discipline and one year of progressively responsible experience as a technical writer in a medical or biotechnology environment.

 

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
    Toxicology
  • Employment Type
    Full Time
  • Minimum Experience
    Mid-level