Sr. Manager, Drug Substance at Xencor

Pasadena, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 May, 26

Salary

185000.0

Posted On

18 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cell Line Development, Drug Substance Development, Manufacturing, Stability, IND Drafting, IMPD Drafting, Cell Culture, Purification, CDMO Management, Project Management, CMC Documentation, Regulatory Submissions, Quality By Design, Process Characterization, Process Performance Qualification, Contract Negotiation

Industry

Biotechnology

Description

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 www.xencor.com. We have an excellent opportunity for a Sr. Manager, Drug Substance to join our team. This 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 locations. Summary: 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 ADC’s Manages early to late phase drug substance manufacturing activities at external CDMO’s 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 activities Manages 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 outcomes Authors and reviews appropriate CMC sections for regulatory submissions (US, EU, ROW) including the tracking of manufacturing changes Supports 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 agreements Tracks 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 methodologies Manages and provides program inventory and supply chain strategies, along with managing material movement Adheres to all department and company-wide policies regarding conduct, performance and procedures Performs other duties as required. Education/Experience/Skills: Position requires a bachelor’s 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 master’s 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 development Proven 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, and cross-cultural project teams Ability to manage and lead multiple complex projects while prioritizing individual and team efforts accordingly Strong attention to detail and analytical problem-solving skills Proficiency in basic project management methodology and tools Proficiency in MS office suite including Excel, Power Point, and Project Understanding of CMC regulatory requirements for US, EU, and ROW for clinical and commercial products Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment. Expected Base Salary Range: $160,000 - $185,000 The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/. 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.

Responsibilities

This role is responsible for the technical management and program planning of Drug Substance activities, including cell line and drug substance development, manufacturing, stability, and regulatory drafting. The manager will provide technical expertise across various modalities and manage early to late phase manufacturing activities at external CDMOs.