Director/Senior Director, Program Management CMC Program Leader
Editas Medicine, United States

Editas Medicine is a transformative genome editing company with a mission to translate its genome editing technology into a novel class of human therapeutics that enable precise and corrective molecular modification to treat a broad range of diseases at the genetic level.

We are seeking an experienced CMC program manager professional to serve as CMC Program Leader for several Editas’ development programs. The ideal candidate will have a strong CMC technical background and experience developing drugs in Immunology, Oncology or Ophthalmology indications and/or cell and gene therapies. The candidate is expected to leverage their knowledge and experience to play a leadership role on Editas’ cross-functional CMC teams to translate CRISPR technology into new medicines for patients by managing efforts that support the development and operationalization of Editas’ clinical programs.

Responsibilities

• Lead cross-functional CMC (Chemistry, Manufacturing, and Controls) team supporting the development and operationalization of Editas’ Cell and Gene Therapy programs. With responsibility for budget and all relevant CMC source documents necessary for regulatory filings or health authority interactions.
• This is a matrix leadership role that collaborates across multiple functions to arrive at a comprehensive CMC development plan. 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 extensive product development 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 technical development plan, and recognizing and solving critical CMC issues with the Project Team and the department.
• Effectively manage CMC 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.
• Manage and drive the various parts of the timeline with the sub-teams and escalate issues as required.
• 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.
• Responsible for the preparation of monthly status reports
• Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.

Requirements

• Advanced degree and 10+ years of multi-disciplinary experience in the cell and gene therapy/biotech/pharmaceutical industry with 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.
• Experience leading cross function development and/or operational teams, developing and commercializing cell/gene therapy products
• Advanced 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
• Process development/engineer background
• 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.

Job Rewards and Benefits