People Matter

Manager, mRNA Process Development

Editas Medicine

Editas Medicine

Cambridge, MA, USA
Posted on Nov 13, 2024

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

Why Choose Editas?

At Editas Medicine, we’re a team of courageous problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!

Decoding The Role:

The in vivo Gene Editing and Critical Component Process Development team in the Technical Development Department is seeking a highly motivated and experienced technical leader in messenger RNA (mRNA) product development. The successful candidate will help drive mRNA process development effort, working with external and internal stakeholders, to advance Editas’ in vivo gene medicine portfolio utilizing nanoparticle technology. The individual will also contribute to the overall program CMC strategy. This role requires strong technical expertise in mRNA manufacturing process design and development as well as a passion to educate and collaborate with others.

Characterizing Your Impact:

As the Manager, mRNA Process Development you will:

  • Drive the execution of Process Development (PD) strategy for mRNA drug substance for multiple LNP-based gene editing programs towards IND and clinical manufacturing
  • Leveraging external resources, act as a Subject Matter Expert for mRNA process science to support mRNA manufacturing process definition, scale-up, and continuous improvement to meet clinical manufacturing demand
  • Lead/support technology transfer (TT) of mRNA manufacturing process to external manufacturing facilities for clinical manufacturing, in collaboration with other Technical Development teams as well as Technical Operations and Quality teams
  • Provide technical and operational oversight of external production of representative mRNA materials at Contract Research Organizations (CRO)/Contract Development and Manufacturing Organizations (CDMO) to enable analytical method development, formulation development and toxicology studies
  • Build and maintain good working relationships with internal and external stakeholders e.g. Research, Development, Quality, suppliers, CDMOs, etc
  • Support CMC strategy development, implementation, and refinement for pertinent programs through strong collaboration with key stakeholders and external partners
  • Independently analyze data from PD and TT projects, present results and conclusions to the team
  • Train peers/junior staff members on mRNA process and product knowledge
  • Author and review of technical reports, SOPs, work instructions and regulatory submissions as needed
  • Maintain abreast latest industry trends for nucleic acid-based manufacturing process and product knowledge, work cross-functionally (e.g. with Research, Business Development and Legal) to evaluate novel manufacturing technologies and new business partners