Manager, Scientific & Technical Writing

Preclinical Sciences · Monrovia, California
Department Preclinical Sciences
Employment Type Full Time
Minimum Experience Manager/Supervisor

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 Manager, Scientific & Technical Writing 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.


This is a hybrid position based out of our Monrovia, Ca. site with 2 days onsite weekly.

 

Summary:

Responsible for drafting, editing, and reviewing technical reports, scientific manuscripts, regulatory filings (e.g., INDs) and other documents in collaboration with Xencor Research, including management of the document generation process.


Job Duties Include:

  • Serves as the lead scientific writer supporting Xencor Research (including Preclinical Development and Preclinical Operations functions) to produce technical reports required for development of clinical candidates
  • Serves as the lead scientific writer supporting Research to generate other regulatory documentation (e.g., INDs, BLAs, their updates and associated documents)
  • Serves as the lead scientific writer, in collaboration with Research, to prepare scientific manuscripts and posters, SOPs, CAPAs, analytical methods, qualification and validation reports, and other documentation as needed
  • Manages, optimizes, and executes the end-to-end process for authoring, editing, reviewing, verifying and approving regulated technical reports
  • Collaborates closely with research project scientists and managers, preclinical scientists, medical writers, regulatory affairs, and documentation control managers to generate such documents
  • Manages the internal report development process for research and nonclinical regulatory documentation, including overseeing timelines, responsible parties, and deliverables
  • Coordinates the development of technical and study reports from external contract labs for inclusion in INDs and other regulatory filings; reviews, edits, and QCs such reports to meet Xencor quality standards
  • Adheres to and advises on company style guides, templates, and SOPs for document generation, and periodically reviews and updates these documents
  • Performs literature searches and data analysis/reviews as needed to support scientific and technical reports
  • Works with Xencor document control and regulatory groups to ensure proper registration in Veeva Vault
  • Provides training and guidance to research staff on the generation of regulated technical reports as well as other scientific writing
  • Adheres to all department and company-wide policies regarding conduct, performance and procedures
  • May provide oversight and direction to others as needed. When assigned, performs supervision in accordance with the organization’s policies and procedures which may include recruiting, training, communicating job expectations, appraising job performance, delivering feedback and coaching, and providing career development planning and opportunities
  • Performs other duties as required.


Education/Experience/Skills:

Position requires a Master’s degree in a Life Science or related discipline or a relevant writing-focused discipline (e.g., communications, marketing, English or equivalent) and a minimum of 4 years of progressively greater responsibilities and expertise as a technical writer in a medical, pharmaceutical, or biotechnology environment.  A PhD in a relevant field with proven high competency in scientific and technical writing preferred. An immunology background and prior project management experience using project management tools such as Gantt charts, Smartsheet, SharePoint, is preferred. Prior people management experience also preferred. 

 

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

Position also requires:

  • Excellent scientific verbal and oral communication skills, coupled with strong organizational competence
  • Expertise in working with the Microsoft Office program suite, as well as with scientific graphing programs (e.g., GraphPad Prism, Spotfire, etc.)
  • Excellent attention to detail and accuracy in work
  • Ability to think critically and creatively and be able to work independently to determine appropriate actions to resolve complex problems
  • Excellent management, collaboration, communication, and decision-making skills
  • Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
  • Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

 

 

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

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  • Location
    Monrovia, California
  • Department
    Preclinical Sciences
  • Employment Type
    Full Time
  • Minimum Experience
    Manager/Supervisor