Sr. Manager, Drug Substance

Xencor is a public clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development and three XmAb medicines have been marketed by partners. For more information please visit . We have an excellent opportunity for a Sr. Manager Drug Substance to join our is a hybrid position with a minimum of 2 days a week onsite. This position can be based out of our San Diego or Pasadena California : Responsible for technical management and program planning of Drug Substance including cell line and drug substance development manufacturing and stability and IND/IMPD drafting Primary Responsibilities:Supports the product pipeline by providing technical expertise in cell line development cell culture and purification to support a variety of modalities bispecific fusion proteins cytokines and ADCs Manages early to late phase drug substance manufacturing activities at external CDMOs by providing technical insight and direction including onsite during Person in Plant (PIP). Provides project/program management including creating/managing timelines reviewing budgets and reviewing and approving applicable documentation activitiesManages related CMC documentation activities such as development activities manufacturing batch records SOPs Technical Reports and Deviations Serves as CMC lead contact on assigned projects/programs and facilitates cross functional interactions (internal and external) to achieve desired outcomesAuthors and reviews appropriate CMC sections for regulatory submissions (US EU ROW) including the tracking of manufacturing changesSupports DS Manufacturing Quality by Design (QbD) Process Characterization (PC) and Product Performance Qualification (PPQ) activities for late phase to commercial programs Manages contracts including negotiations for technology transfer manufacturing and supply agreementsTracks and monitors periodic reports on performance issues risks and schedules of key activities events or milestones Evaluates operations for strategic process improvements recommends appropriate solutions Works collaboratively and transparently with CMC Operations Protein Sciences Quality Assurance Regulatory Affairs and Program Management Responsible for high-quality and timely deliverables via the use of appropriate tools and methodologiesManages and provides program inventory and supply chain strategies along with managing material movementAdheres to all department and company-wide policies regarding conduct performance and proceduresPerforms other duties as requires a bachelors degree in a relevant Science or Engineering discipline and at least 8 years of experience in biotechnology or pharmaceutical industry including contract manufacturing quality engineering Process Development or other related functional experience. A masters in engineering life/physical sciences or other technical field of study with at least 6 years experience is preferred. Also requires experience as a CMC project lead working with or for a Contract Development Manufacturing Organization (CDMO) and experience authoring CMC sections for regulatory documents (IND IMPD BLA/NDA). Process Characterization (PC) and Process Performance Qualification (PPQ) activities to support late phase to commercial programs is preferred as well as experience leading technical individuals or small teams. Position also requires:Strong business knowledge of Biotechnology/Pharmaceutical manufacturing operations product and process developmentProven management skills with ability to tactfully and effectively negotiate and influenceDemonstrated interpersonal skills to develop and maintain effective working relationships with internal and external stakeholders as well as cross-functional and cross-cultural project teamsAbility to manage and lead multiple complex projects while prioritizing individual and team efforts accordinglyStrong attention to detail and analytical problem-solving skillsProficiency in basic project management methodology and toolsProficiency in MS office suite including Excel Power Point and ProjectUnderstanding of CMC regulatory requirements for US EU and ROW for clinical and commercial products Ability to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelOccasional travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $160000 - $185000The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe 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 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 Employment Opportunity (EEO) StatementThe 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 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.