Director, CMC Internal Operations

Editas Medicine Cambridge , MA 02138

Posted 3 days ago

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. Were focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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 many diseases.

Were looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before.

Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world. If the answer is yes, then Editas Medicine is the place for you.

This new role on the Editas Manufacturing team provides a unique opportunity to contribute to the clinical translation of CRISPR technology by managing efforts that support the development and operationalization of Editas clinical programs.

Responsibilities:

Lead internal CMC (Chemistry, Manufacturing, and Controls) team supporting the development and operationalization of Editas Cell Therapy program. Ensure compliance with cGMPs for the manufacture of pre-clinical and clinical materials.

  • The role is the primary contact for the strategic relationship with our clean room provider and will be required to provide support for the activities of several functions within Editas. This support would include but not limited to:
    • Scheduling of activities in the facility
    • Managing material flows, receipt of new materials, and material preparations for activities scheduled for the facility
    • Oversite and design of the training program for the operations team at the facility. Ensure that other functions utilizing the facility are appropriately trained.
    • Organizing the requested shipments from the facility to required locations
  • Responsible for the annual budget cost of running the facility, including cost associated with the strategic partnership with the clean room provider.
  • This is a matrix leadership role that collaborates across multiple functions to accomplish the pre-clinical and clinical manufacturing requirements for the programs at Editas.
  • This is a highly visible and influential role in the organization that will interact extensively with line function heads and team members within CMC, Program Team members, and Editas leadership. To be successful in this role, the ideal candidate must have expertise in biotechnology or cell and gene therapy areas, regulatory and compliance awareness, strategic thinking, strong business acumen, excellent leadership and influencing skills.
  • This role will represent CMC as part of the Program Team by defining and communicating CMC strategic operational direction, serving as a visible program champion and a focal point for critical program information, compiling the operations activities plan, and recognizing and solving critical operations issues with the Project Team and the department.
  • Effectively manage facility team meetings including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items using effective PM tools and systems.
  • Proactively identify program risks and work with the team to conduct risk assessments and define appropriate mitigation plans.
  • Develop critical path analyses to identify potential ways to accelerate timelines and mitigate risks.
  • Promote a culture of Community, Innovation and Results within Editas

Requirements

Advanced degree or equivalent and 10+ years of multi-disciplinary experience in the cell therapy/biotech/pharmaceutical industry with 3 years of management/supervisory experience and multiple years leading and being part of cross functional teams

• Exceptional organizational skills with the ability to multi-task and prioritize assignments, strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines.
• Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP and GTP operations.
• Understanding of product development life cycle and stage gates from development to commercial operations
• Experience with custom media development, production, and CE marking
• Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors

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Director, CMC Internal Operations

Editas Medicine