Director/Senior Director, Program Management CMC Program Leader
Company: Editas Medicine
Posted on: April 9, 2021
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.
- 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
- 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
- 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
- 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
- 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
- Experience leading cross function development and/or
operational teams, developing and commercializing cell/gene therapy
- Advanced knowledge of FDA, EMA and ICH regulations, industry
standards and quality control principles for GMP and GTP
- Understanding of product development life cycle and stage gates
from development to commercial operations
- Experience with custom media development, production, and CE
- Demonstrated technical proficiency, scientific creativity,
independent thought, and ability to effectively collaborate with
- Experience working with all levels of management and consulting
with key business stakeholders. An ability to influence for greater
- Strong team player that has a customer service approach and is
- Attention to detail and the ability to work individually,
within a multi-disciplinary team in a matrix environment, as well
as with external partners. Editas Medicine does not discriminate on
the basis of race, sex, color, religion, age, national origin,
marital status, disability, veteran status, genetic information,
sexual orientation, gender identity or any other reason prohibited
by law in provision of employment opportunities and benefits.
Keywords: Editas Medicine, Cambridge , Director/Senior Director, Program Management CMC Program Leader, Executive , Cambridge, Massachusetts
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