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:
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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