W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9wb2x0ihjlzgvzawduic9wbmcvam9icy5wbmcixv0

Director, Cell/Gene Therapy

Director, Cell/Gene Therapy

  • Location

    Cambridge, Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    € benefits package

  • Contact:

    Connor Harknett

  • Contact email:

    Connor.Harknett@volt.eu.com

  • Job ref:

    19985-PHARM-CKT_1563205263

  • Published:

    3 months ago

  • Expiry date:

    2019-08-14

  • Start date:

    August 2019

  • Consultant:

    #

A rare opportunity has risen for an experienced individual to join a global company at a senior level. This opportunity will allow you exert your skill set in a leadership role in Gene and Cell Therapy (team is to drive assay development that supports my Clients product portfolio of early-late-stage clinical cell/ gene therapy products. Your time in this Company will be exciting and challenging, your strategic input will not be under-valued! The candidate will be responsible for direct supervision of scientific staff and strong collaboration with stakeholders.

Roles/Responsibilities

*Define the scope of the commercial strategy for oncology cell/gene therapy pipeline assets in order to provide guidance to R&D teams in prioritising opportunities and helping to set the strategic development.
*Lead early and late stage analytical development method qualification and transfer for Cell/Gene products.
*Ensure you are a technical leader and persuasive liaison to Clients, contractors and stakeholders guaranteeing quality checks and release criteria for clinical materials.
*Act as a liaison to senior management, cross-functional teams and external organisations.
*Provide data summaries for CMC/CTD documents for regulatory filings with US and EU regulatory agencies.
*Manage the Laboratory team and provide scientific leadership in analytical design and methods development during release and stability testing for Cell/Gene therapy products.
*Provide input for development and refinement of the company strategic vision and objectives for Cell/Gene therapy.

Requirements
*Minimum of 8-10 years directly related experience in biotechnology or pharma industry.
*PhD in immunology, cell biology, molecular biology or equivalent field with preferred industry experience in Cell/Gene Therapy.
*Demonstrated leadership skills in working with cross functional teams.
*Have a broad understand of GMP, QC, GLP, FDA, EMA, and ICH regulatory requirements.
*Outstanding communication and organisational skills to demonstrated drive for results.

Do reach out to me at or +44 07771 976356