Senior Manager- CMC Operations, Drug Product Packaging and Labeling

CMC Operations · Monrovia, California
Department CMC Operations
Employment Type Full Time
Minimum Experience Senior 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 other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Senior Manager- CMC Operations, Drug Product Packaging and Labeling  to join our team.

 

Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.

 

We seek a Senior Manager- CMC Operations, Drug Product Packaging and Labeling responsible for supporting key activities related to planning, shipping & logistics, labeling, packaging, storage, and distribution through external vendor oversight for multiple clinical trials. Project oversight will include creating/managing timelines, reviewing budgets, and reviewing/approving various documentation activities.  We are looking for a professional who has extensive experience in the biotech/pharmaceutical industry with an excellent understanding of the drug development and distribution process both domestically and internationally. This individual will independently forecast and manage supply needs and distribution. The position will report to the Senior Director, CMC Operations -Drug Product/Packaging and Labeling.

 

This position will interact with multiple levels within the organization.  Candidate must have the ability to approach issues from both a strategic and tactical perspective.  Additionally, the successful candidate must demonstrate business acumen, communication/presentation skills, and the ability to influence others.  This includes but is not limited to: the ability to effectively drive both internal and external (virtual) team discussions, through active engagement of multiple client relationships supporting various components of the product supply chain.

 

This Sr. Manager position presents an opportunity for a qualified candidate to further enhance their leadership skills, demonstrate proficiency in project management and versatility and cultivate their overall understanding of Xencor’s business.

 

 Job Duties include:

  • Manage direct outsourcing of labeling, packaging, storage, and distribution of manufactured drug supply and co-administered and/or comparator supplies, as required, for domestic and international studies.
  • Manage drug supply forecast including timeline, budget, and component requirements for packaging and labeling operations. Support patient study needs that consider enrollment rates, country logistics for shipping and importation, drug expiry, inventory re-supply strategy and the appropriate level of inventory.
  • Plan, execute, and track domestic and international shipments by maintaining close partnerships with contract packagers and couriers. Analyze and monitor shipping temperature and storage site data and participate/lead investigations for excursions with Quality.
  • Identify issues and/or risks while meeting clinical supply requirements. Suggest solutions to meet timelines.
  • Prepare and review required shipping documentation as needed to ensure compliance with domestic as well as Global Customs and Trade regulations.
  • Well-versed with regulatory requirements for INDs and NDAs including global GMPs and GCPs.
  • Work collaboratively and transparently with CMC Operations, Clinical Operations, Quality Assurance, and Regulatory Affairs.
  • Deliver high quality and timely deliverables via the use of appropriate PM tools and methodologies.
  • Ability to work at a high pace in a changing environment while delivering high quality and timely deliverables.

 

Qualifications/Requirements:

 

  • Minimum of Bachelor’s degree with 8 years’ experience or Master’s degree with 6 years of experience in Project Management, Clinical Supply, Clinical Packaging and/or Pharmaceutical Development required.
  • Minimum of 5 years’ experience in clinical supply management including forecasting, logistics (labeling, packaging, storage, distribution, expiries), inventory tracking, and managing inventory management system.
  • Minimum of 5 years’ as a CMC project lead working with or for a Contract Packaging Organizations (CPO).
  • Thorough understanding of US, EU, and ROW clinical supply labeling, distribution, and regulatory requirements.
  • Business knowledge of Biotechnology/Pharmaceutical packaging and supply chain operations.
  • Experience in managing several complex projects and prioritizing individual and team efforts accordingly.
  • Strong 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.
  • Team player and self-starter who is capable of growth and increased responsibility.
  • Detail oriented and good analytical problem-solving skills.
  • Proficient in basic project management methodology and tools.
  • Proficiency in MS office suite including Excel, Power Point, and Project.

 

Preferred Qualifications:

 

  • Extensive expertise in Drug Product packaging, labeling, storage, and distribution working with or for a Contract Packaging Organization (CPO) within the Pharmaceutical/Biotech or Healthcare industry.
  • 8+ years’ experience as a CMC project lead working with or for a Contract Packaging Organizations (CPO).
  • Experience establishing, managing, and executing an inventory management system.
  • Experience with launching commercial products both domestically and internationally utilizing serialization and track and trace applications.
  • Advanced degree in Business (MBA) a plus.

 

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 to recruiting@xencor.com.

 For further information about Xencor, please visit our website at www.xencor.com EOE

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