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Director, Technical Operations (I/O Cell Therapeutics)

If interested and qualified, please include Requisition # 2017-229 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

As a senior member of the Tech Ops organization, this position reports to the VP, Manufacturing & Process Development and focuses on the Company’s lead immune oncology cell therapy program.  Throughout the life cycle of the product, the successful candidate will ensure a continuous, integrated knowledge base and understanding of the physical and biochemical properties of the therapeutic product, as well as the manufacturing process and associated analytical control methods. A critical aspect of the role is to ensure a “line of sight” throughout the supply chain (critical raw materials, starting materials, Drug Substance (as applicable), Drug Product, distribution) and throughout the product lifecycle (Development, Tech Transfer, Process Validation, and Commercial Manufacturing) to ensure appropriate control of product quality. 

This person represents Tech Ops on the CRISPR Tx corporate core team for the immune oncology cell therapy program and leads the cross-functional Tech Ops sub-team.  Additionally, this person is the focal point for the management of technical knowledge, accountable for the development and maintenance of the Process Control Strategy, and supports individual sites in the development of Operating Control Strategies.  The successful candidate will serve as the expert and plays a pivotal role in providing input and context in cases of significant deviations, investigations and continuous improvements projects.

 This person works in close collaboration with site tech services teams and applicable Development, Quality, Operations, and Engineering teams.

Responsibilities 

  • Mastery of scientific/technical aspects of the process, product, analytical development, regulatory filings, and commercial manufacturing history
  • Has in depth understanding of:
      • Why process parameters are deemed critical or not and the rationale of their control strategy
      • Raw material and excipient criticality with regard to product and process performance
      • Stability and degradation pathways
      • Process and assay capability
  • Consults regarding ongoing critical investigational events and technical studies
  • Determines impact assessments of change controls
  • Implements knowledge documentation approach/system, and is responsible for keeping the knowledge content up to date at all times
  • Accountable for the development and maintenance of the Process Control Strategy and supports the sites’ Operating Control Strategies development
  • Advises on process risk profiling as well as identification of required corrective actions
  • Assists with the establishment of the post-approval Technical Life Cycle agenda, keeps oversight, understands the rationale and status of projects included in the agenda
  • Stays current on industry best practices related to process & product control technology
  • Performs other duties, as assigned

Minimum Qualifications

  • PhD or Master’s Degree in Chemistry/Pharmaceutical Sciences with 10+ years’ relevant experience
  • Deep and relevant knowledge of manufacturing processes and related unit operations
  • Knowledge of regulatory filings and the drug development process
  • Knowledge of current state of the art technologies and emerging scientific and regulatory guidance for cell and gene therapy manufacturing and testing processes
  • In-depth scientific knowledge
  • Ability to work in a matrix environment
  • Recognized in the scientific and engineering community through a record of publications, presentations and/or patents

Preferred Qualifications

  • Expert understanding of process and assay development, transfer, and validation as well as commercial manufacturing and control
  • Experience managing outsourced process development, testing, and manufacturing projects
  • Knowledge and experience in at least one of the areas of gene editing, cell therapy, and viral vectors
  • Ability to share and apply knowledge in support of technical challenges
  • Strong technical networker
  • Excellent interpersonal / communication skills and team-player
  • Excellent and effective communication skills

Competencies

  • Communication and Teamwork – The ability to effectively express ideas in written and oral context.  The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
  • Customer Focus – The desire to understand and anticipate internal/external customer needs and take action to meet or exceed these needs.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
  • Results Oriented – Drives issues to closure and gets the job done.
  • Strategic Thinking – The ability to develop strategies and goals that recognize scientific/business issues, opportunities, and environment.

If interested and qualified, please include Requisition # 2017-229 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.