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Manager, Project & Portfolio Management, Regulatory CMC

United States - California - Santa MonicaRegulatoryRegular

Job Description

Kite is seeking a highly motivated individual to join us as a Manager, Project Management, to work in the exciting area of cancer immunotherapy.  This position will provide project and portfolio management to the Regulatory CMC team in a dynamic and fast paced organization. The preferred candidate will possess strong interpersonal skills as this position interacts with all levels of employees in Regulatory Affairs, Process Development, Quality, Supply Chain, and Manufacturing.

Are you interested in helping ensure timely execution of CMC strategy in a cell therapy setting? Come join us in our mission to cure cancer!

RESPONSIBILITIES:

  • Manage the global Regulatory CMC portfolio of submission and labelling activities including tracking, organizing, and verifying complex information from multiple sources
  • Analyze and visualize data for portfolio reviews and reporting utilizing various tools (e.g dashboards, SmartSheet, SpotFire, Clarity)
  • Collect, consolidate, and analyze portfolio forecast to enable budget preparation
  • Facilitate Regulatory CMC product teams for submission strategy alignment, sequencing and timing
  • Drive cross-functional Regulatory CMC submission project teams and manage deliverables to meet established deadlines
  • Schedule meetings, interface with attendees and arrange for needed resources, maintain calendar, develop PowerPoint presentations, take meeting minutes, manage action item logs and associated follow up with project team members
  • Support the optimization of business processes and tools to improve efficiency and advance Regulatory CMC interactions
  • Provide effective communication and coordination with Regulatory CMC teams and Technical Operations teams and proactively update stakeholders on progress and issues  (e.g. project dashboards, reporting)
  • Develop and maintain SharePoint and internal company websites for information sharing and collaborative document authoring

REQUIREMENTS:

  • MBA/MA/MS in Sciences or Engineering with 5+ years of experience in the biotech or pharmaceutical industry, OR
  • BA/BS in Sciences or Engineering with 7+ years of experience in the biotech or pharmaceutical industry, OR
  • HS Diploma with 11+ years of experience in the biotech or pharmaceutical industry

ADDITIONAL QUALIFICATIONS:

  • Experience managing multiple projects simultaneously and resolving conflicts related to meeting numerous deadlines
  • Knowledgeable with the drug development process, cell therapy industry, and Regulatory CMC practices; Module 3 experience strongly preferred
  • Ability to take initiative and think critically with demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Proficient in MS Word, Excel, PowerPoint, SharePoint, Outlook and visualization tools (e.g. Smartsheet, SpotFire, Tableau, Power BI); MS Project, Documentum, document formatting tools experience a plus
  • Ability to interact with staff at all levels in a fast-paced environment, remaining flexible, resourceful, and efficient, with a high level of professionalism and confidentiality