CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Director/Senior Director, Program Management CMC Program Leader

Company: Editas Medicine
Location: Cambridge
Posted on: April 9, 2021

Job Description:

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
    • 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. 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Commercial Banking Relationship Manager (New England)
Description: Santander---s Commercial Banking Division is an active provider of capital, treasury management and risk management solutions to thousands of small and mid-sized companies in the northeast and across (more...)
Company: Santander Holdings USA Inc
Location: Mattapan
Posted on: 04/17/2021

Food and Beverage Manager/Supervisor
Description: GROW With US br br For 30 years Hudson Group has led the way and prides itself in knowing what matters in travel retail. As airports and transportation terminals have evolved, so has Hudson Group, (more...)
Company: Hudson Group
Location: Boston
Posted on: 04/17/2021

Integrated Pest Management Plant Scout
Description: PARALLEL br Location: 5 Forge Pkwy, Franklin, MA br Everyone is welcome here. Each of us is unique, and that's what makes us amazing. We believe in inclusiveness and celebrating each person's individuality, (more...)
Company: Neta
Location: Walpole
Posted on: 04/17/2021


Integrated Pest Management Plant Scout - Cannabis
Description: PARALLEL br Location: 5 Forge Pkwy, Franklin, MA br Everyone is welcome here. Each of us is unique, and that's what makes us amazing. We believe in inclusiveness and celebrating each person's individuality, (more...)
Company: Neta
Location: Norfolk
Posted on: 04/17/2021

Food Service Manager
Description: WE ARE OFFERING ELIGIBLE CANDIDATES A ONE-TIME 300 SIGN-ON BONUS br br GROW With US br br For 30 years Hudson Group has led the way and prides itself in knowing what matters in travel retail. (more...)
Company: Hudson Group
Location: Saugus
Posted on: 04/17/2021

Major Clients Account Manager
Description: Major Clients Account Manager Professional Staffing Group is one of the largest Boston based staffing firms and due to our growth, we are looking to add an Account Manager to our major clients team to (more...)
Company: Professional Staffing Group
Location: Everett
Posted on: 04/17/2021

Managing Director, Tax Transaction Advisory Services
Description: Our professionals balance analytical skills, deep market insight and independence to deliver solid, defensible analysis and practical advice to our clients. As an organization, we value the diverse backgrounds (more...)
Company: DUFF AND PHELPS, LLC
Location: Wakefield
Posted on: 04/17/2021

Assistant Manager
Description: We are hiring at BOSTON DOMINO'S TEAM ELITE IS LOOKING
Company: Dominos Team Elite
Location: Boston
Posted on: 04/17/2021

Wealth Management Planning Consultant - Greater New England Market
Description: Job Description:Job DescriptionFor you, client interactions aren't just transactions. They're relationships that need to be nurtured. Your innate personality makes you an ideal candidate to be a Relationship (more...)
Company: Fidelity Investments
Location: Burlington
Posted on: 04/17/2021

Integrated Pest Management Plant Scout
Description: PARALLEL br Location: 5 Forge Pkwy, Franklin, MA br Everyone is welcome here. Each of us is unique, and that's what makes us amazing. We believe in inclusiveness and celebrating each person's individuality, (more...)
Company: Neta
Location: Foxboro
Posted on: 04/17/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds