Senior Manager, CMC Operations- Drug Product

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 Sr. Manager, CMC -Drug Product 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.

 

Our employees are the most important factor to our success. 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. This is accomplished through scientific rigor, a passion for innovation, and a willingness to take risks.

 

We seek a Sr. Manager, CMC Operations- Drug Product to be responsible for providing technical insight and project planning/management of drug product development, including Person in Plant responsibilities.  The subject matter expert (SME) will additionally provide technical expertise in formulation development screening to support 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. Project oversight will include creating/managing timelines, reviewing budgets, reviewing/approving various documentation activities that will include manufacturing batch records, SOPs, Technical Reports, and Deviations.  Assistance with authoring and reviewing CMC regulatory content in support of future and existing filings is expected.  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 and provide technical input to support early to late phase drug product manufacturing activities at external CMOs. Person-in-Plant responsibilities. Experience with global product distribution a plus.
  • Biopharmaceutical Drug Product formulation screening development and clinical in-use studies to support clinical product portfolio.
  • Serve as CMC project(s) contact and manage cross functional interactions (internal and external) to achieve desired outcomes.
  • Provide CMC manufacturing documentation review (i.e. reviewing/approving manufacturing batch records, investigations, SOPs, Technical Reports).
  • Author appropriate CMC sections for regulatory submissions (US, EU, ROW) including tracking of manufacturing changes.
  • Support future DP Manufacturing Quality by Design (QbD) and Product Performance Qualification (PPQ) activities for late phase to commercial programs.
  • Manage contracts, including negotiations for technology transfer, manufacturing, and supply agreements.
  • Manage and track periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones.
  • Work collaboratively and transparently with CMC Operations, Clinical Operations, Quality Assurance, Regulatory Affairs, and Program Management.
  • 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 in relevant Science or Engineering Discipline with 8 years’ experience or Master’s degree in relevant Science or Engineering Discipline with 6 years of experience.
  • Minimum of 5 years’ experience in biotechnology or pharmaceutical industry including contract manufacturing, quality or engineering experience, Process Development, or other related functional experience.
  • Experience as a CMC project lead working with or for a Contract Manufacturing Organization (CMO).
  • Business knowledge of Biotechnology/Pharmaceutical manufacturing operations, product and process development and supply chain operations.
  • Experience in managing several complex projects and prioritizing individual and team efforts accordingly.
  • Experience in authoring CMC sections for regulatory documents (IND, IMPD, BLA/NDA).
  • 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:

 

  • Master’s degree (MS) in engineering, life/physical sciences or other technical degree.
  • Extensive expertise in Drug Product Development, Manufacturing, and other related functional areas within Pharmaceutical/Biotech.
  • 5+ years’ experience as a CMC project lead working with or for a Contract Manufacturing Organization (CMO).
  • Experience in DP Manufacturing Quality by Design (QbD) and Process Performance Qualification (PPQ) activities to support late phase to commercial programs.
  • Proficient understanding of CMC regulatory requirements for US, EU, and ROW for clinical and commercial products.
  • 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.  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