Sr. Manager, Drug Substance

Xencor • Pasadena, CA

3d • Hybrid

About The Position

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,

Requirements

• 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.
• 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).
• 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

Nice To Haves

• A master’s in engineering, life/physical sciences or other technical field of study with at least 6 years’ experience is preferred.
• 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.

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.

Benefits

• 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/.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees