Associate Director, Drug Product

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

This position is a hybrid position based in our Monrovia, CA. location.  

 

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 an Associate Director, Drug Product 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 technical oversight and project planning/management of drug product development, including Person-in-Plant responsibilities.  


Job Duties Include:

  • Provides extensive technical expertise in formulation development screening to support a variety of dosage applications (IV, subcutaneous, continuous infusion), clinical in-use studies to support clinical product portfolio, and QbD and PPQ evaluation activities to support later phase clinical-to-commercial programs.
  • Provides project lead oversight including creating/managing timelines, reviewing budgets, and reviewing and approving various documentation activities including manufacturing batch records, SOPs, Technical Reports, and Deviations
  • Manages and provides detailed technical insight and direction to support early to late phase drug product manufacturing activities at external CMOs
  • Develops biopharmaceutical drug product formulation screening and clinical in-use studies to support clinical product portfolio
  • Serves as CMC project(s) lead contact and manages cross functional interactions (internal and external) to achieve desired outcomes
  • Provides CMC manufacturing documentation review and process improvements (i.e., reviewing/approving manufacturing batch records, investigations, SOPs, Technical Reports)
  • Authors and reviews appropriate CMC sections for regulatory submissions (US, EU, ROW) including tracking of manufacturing changes
  • Supports future DP Manufacturing Quality by Design (QbD) and Product Performance Qualification (PPQ) activities for late phase to commercial programs
  • Manages contracts, including negotiations for technology transfer, manufacturing, and supply agreements.
  • Manages and tracks periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones
  • Provides insight to strategic process improvements and implementation
  • Works collaboratively and transparently with CMC Operations, Clinical Operations, Quality Assurance, Regulatory Affairs, and Program Management
  • Delivers high-quality and timely deliverables via the use of appropriate PM tools and methodologies
  • Adheres to all department and company-wide policies regarding conduct, performance and procedures
  • Performs other duties as required.

 

Education/Experience/Skills:

Position requires a Bachelor’s degree in a relevant Science or Engineering discipline and at least 10 years of related experience; a Master’s degree with at least 8 years of experience is preferred.  A minimum of 10 years of experience in biotechnology or pharmaceutical industry including contract manufacturing, quality or engineering experience, Process Development, or other related functional experience and experience as a CMC project lead working with or for a Contract Manufacturing Organization (CMO) also required.  Requires experience authoring CMC sections for regulatory documents (IND, IMPD, BLA/NDA).  Prior experience as a CMC project lead working with or for a Contract Manufacturing Organization (CMO) and working in DP Manufacturing Quality by Design (QbD) and Process Performance Qualification (PPQ) activities to support late phase to commercial programs are preferred

 

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

 

Position also requires:

  • Extensive business knowledge of Biotechnology/Pharmaceutical manufacturing operations, product and process development and supply chain operations
  • Proven management skills with ability to tactfully and effectively negotiate and influence
  • Demonstrated interpersonal skills to develop and maintain effective working relationships with internal and external stakeholders as well as cross-functional, cross-cultural project teams
  • Ability to manage and direct multiple complex projects while prioritizing individual and team efforts accordingly
  • Strong attention to detail and analytical problem-solving skills
  • Proficiency in basic project management methodology and tools
  • Proficiency in MS office suite including Excel, Power Point, and Project
  • Proficient understanding of CMC regulatory requirements for US, EU, and ROW for clinical and commercial products preferred



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