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Associate Director/Director, Process Development (Cell Therapy)

Directions to apply Submit your resume to careers@beamtx.com

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Beam is seeking a highly energetic individual who has deep technical knowledge in Cell and Gene Therapy space to be a strategic leader responsible for technical development and CMC activities that enable programs from preclinical stages through Phase I trials. In addition to technical expertise, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams, engage and collaborate with external partners in process development and manufacturing. This position will play an important role in developing the clinical manufacturing processes and analytical methods for developing cellular therapy products. Builds and leads a group of scientists in overseeing clinical preparedness. Independently plans and executes process and assay development, characterization and qualification studies. Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials.

 

Primary Responsibilities:

  • Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks
  • Good understanding of cGMP environment, and the use of Design of Experiment (DOE), and Quality by Design (QBD) principles for process and assay development, qualification and validation
  • Experience in Process Tech Transfer to CMOs
  • Experience in supporting Clinical Projects
  • Risk analysis and management
  • Reviews, interprets and communicates data cross-functionally within CMC and/or project teams
  • Serves as a technical resource for junior staff
  • Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
  • Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
  • Proactively analyses manufacturing issues and coordinates potential resolution with the team

 

 

Qualifications:

  • PhD or MS in Pharmaceutical Sciences, Chemistry, Biotechnology, Chemical Engineering
  • 8-12 years of experience in a Pharmaceutical company or a CRO/CMO
  • cGMP experience in the cell and gene therapy space is required
  • Strong background in Cell processing, scale up and tech transfer
  • Strong Analytical background in Cell differentiation, stability and Characterization
  • Experience in upstream and downstream purification methodologies
  • Good understanding of current regulatory landscape for Ex-Vivo approaches
  • Independent thinker and team player