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Sr. Director, GMP Process Technology

If interested and qualified, please include Requisition # 2016-142 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

Reporting to VP, Tech Ops, the primary responsibility of the role of Sr Dir GMP Process Technology is to provide oversight of diverse suppliers to CRISPR Therapeutics of cGMP materials including autologous cell products, viral vectors, lipids, oligonucleotides, and proteins. In addition, the position provides vision and leadership within a matrix environment regarding identifying, evaluating, and proposing applications of analytical and manufacturing technology to enhance the safety, efficacy, and economics of the Company’s products.

Responsibilities 

  • Accountable for inception to implementation of GMP manufacturing at contract manufacturing organizations
  • Collaborate with Research, Development, Quality, and Supply Chain functions to ensure timely release of batches and adequate inventory
  • Work with Quality and CMO to resolve change controls, deviations, and CAPAs
  • Troubleshoot technical issues and improve quality by providing technical guidance
  • Communicate clearly within the Company and with external partners
  • Evaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve Company’s products and processes

Minimum Qualifications

  • Ph.D. with a minimum of 14 years of relevant experience in biotech/pharma manufacturing and development

Preferred Qualifications

  • Ph.D. and 17+ years relevant experience in biotech/pharma manufacturing and development
  • Significant experience in cGMPs and applicable regulations and guidance
  • Proven track record of technology application accomplishments
  • Experience in some or all of the following areas: PAT, manufacturing processes for small molecules, polymers/oligomers, recombinant proteins, viral vectors, autologous cell therapies

Competencies

  • 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.
  • Strategic Thinking – The ability to develop strategies and goals that recognize scientific/business issues, opportunities, and environment.
  • Manage Expectations – The ability to appropriately prioritize as well as set expectations with team, manager, direct reports, internal and external clients. The ability to reset expectations when met with obstacles.
  • Leverage Systems & Technology – Uses systems and technology in a facile way. Identifies opportunities to improve processes through systems and technology.
  • Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.
  • Self-Development and Flexibility – Understands and leverages internal and external resources. Continuously educates oneself to stay current with functional and industry knowledge. Shows initiative and demonstrates learning orientation and flexibility.

If interested and qualified, please include Requisition # 2016-142 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.