Director of MSAT - Cell & Gene Therapy

Posted 18 April 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
DisciplineCell & Gene Therapy
Contact NameNikhil Akkoo

Job description

Mantell Associates has formed a partnership with one of the most promising organisations in the market, who is currently searching for an experienced Director of MSAT to join their skilled team.

Director of MSAT - Responsibilities:

  • Manage a team to lead, develop and implement scientifically sound and fit for purpose global validation policies and procedures based on current regulations, industry standards and industry practices for cell & gene therapy

  • Support the client with ongoing process operations on site to ensure our clients can meet their objectives while ensuring the processes and hoteling suites remain in a state of control

  • Provide leadership and direction for Site MSAT and manufacturing Technical SMEs to define the validation requirements for execution of clients manufacturing processes

  • Engage with senior levels leaders within company and in our clients to deliver the strategic imperatives for both organizations

Director of MSA - Requirements:

  • Bachelor’s degree with process validation, technology transfer or pharmaceutical manufacturing experience

  • Experience in building organizations to meet the operations requirements

  • 6+ years of directly related industry experience in GMP manufacturing with direct experience managing a team as well as leadership experience leading teams, projects, programs or directing the allocation of resources

  • Ability to engage senior leaders within the organization and our clients

  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) with process validation experience

  • Thorough understanding of cGMP manufacturing

  • Excellent communications and written skills with direct experience supporting significant strategy development & implementation

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.