Sr. Manager, CMC Operations

Employer
Xencor
Location
Monrovia, CA
Posted
Jul 26, 2018
Required Education
Bachelors Degree
Position Type
Full time

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
  • Participate in identifying, creating, and sustaining CMC processes in order to successfully support the growing pipeline of product candidates

Qualifications/Requirements:

  • 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
  • Detail-oriented
  • Proficiency in MS office suite including Excel, Power Point, and Project

Preferred Qualifications:

  • 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. Please submit a cover letter & resume.  For further information about Xencor, please visit our website at www.xencor.com   EOE