Sr. Manager, CMC Operations
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 Operations 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 Manager/Sr. Manager, CMC Operations to be responsible for multiple projects’ planning/management, including person in plant responsibilities. Project oversight will include creating/managing timelines, reviewing budgets, reviewing/approving various documentation including: 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.
This position will interact with multiple levels of 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 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.
Job Duties include:
- Manage CMC/Operations projects, including person in plant responsibilities for ongoing production
- Work within CMC function to help drive and deliver CMC/Operations output for product candidates
- Support contracts, including negotiations for technology transfer, manufacturing and supply agreements
- Deliver high quality and timely deliverables via the use of appropriate PM tools and methodologies
- Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones
- Serve as a CMC project contact with external and internal clients as needed
- Ensure uninterrupted final drug product supply to the clinics/patients
- Participate in identifying, creating, and sustaining CMC processes in order to successfully support the growing pipeline of product candidates
- Bachelor’s degree in engineering, life/physical sciences or other technical degree with at least 5 years of related experience
- Demonstrated interpersonal skills to develop and maintain effective working relationships with internal and external stakeholders and cross-functional, cross-cultural project teams
- Business knowledge of Biotechnology/Pharmaceutical manufacturing operations, product and process development and supply chain operations
- Proven collaboration management, decision making skills and goal-orientation
- Ability to communicate and/or present to all levels of staff and management
- Ability to tactfully and effectively negotiate and influence stakeholders
- Experience in managing several complex projects simultaneously and prioritizing individual and team efforts accordingly
- Be a team player and self-starter who is capable of growth and increased responsibility
- Proficient in basic project management methodology and tools
- Good analytical problem solving skills
- Proficiency in MS office suite including Excel, Power Point, and Project
- Advanced degree (MS, PhD) in engineering, life/physical sciences or other technical degree
- Expertise in Drug Substance/Drug Product Manufacturing, Process Development, or other related functional areas within the Pharmaceutical/Biotech or Healthcare industry
- 2+ years experience as a CMC project manager
- Advanced degree in Business (MBA) a plus
- Experience working with or for a Contract Manufacturing Organization (CMO) a plus
- Certified as Project Management Professional 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.
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.