Manager / Sr Manager GMP Manufacturing (H/F)

Manager / Sr Manager GMP Manufacturing (H/F)


Under the responsibility of the Site lead, the Manager / Sr Manager GMP Manufacturing will oversee the internal GMP manufacturing operations in Valbonne, in support of Sangamo cell therapy portfolio from Technical Transfer to GMP manufacturing of clinical batches for Phase 1/2 clinical studies. This will involve all supporting activities required to produce product lots of acceptable quality: staffing, utilities, documentation, training, etc either directly or in collaboration with Valbonne Process Development and other Technical Operations functional leadership. Additionally, this will also involve:

  • Safety
  • Strategic and tactical planning with R&D and project management at Valbonne. Reporting into this role are Manufacturing technicians and Supply chain/Warehouse.



  • Develop timelines, budgets and execute/coordinate activities for all elements related to the GMP production and fill & finish of clinical drug products including:
    • Process adaptation to GMP – tech transfer
    • Engineering lot production
    • GMP lot production
  • Accountable of the manufactured Product Quality and Patient Safety
  • Oversee GMP production activities, deliverables, and completion relative to budgets and company objectives
  • Coordinate manufacturing activities with Company’s corporate partners
  • Coordinate the generation of reports and documentation for regulatory submissions
  • Working closely with the Process Development, Project Development and Management department, provide ongoing manufacturing planning to R&D project teams
  • Coordinate manufacturing activities and timelines with the Process Development, Clinical Operations and Regulatory Affairs Departments
  • Ensure aseptic activities are in place to produce a compliant drug product
  • Ensure that appropriate training of all manufacturing personnel on equipment, process and facility safety procedures is maintained and up to date.
  • Actively influence and participate in the site leadership team while establishing effective cross-functional leadership relationships with a collaborative culture.
  • Contribute to the company’s overall growth strategy, oversee the departmental budget and headcount, as well as the manufacturing operations’ capital expenditure budget.
  • Establishing and reporting on manufacturing key milestones and KPIs
  • Other activities as may be assigned



The ideal candidate for this position will have:

  • Experience of the cGMP production of aseptic biological pharmaceuticals.
  • Proven track record of managing GMP production operations and budgets
  • Proven team leadership

Candidate must possess:

  • Engineer/Master, PhD or Pharmacist in bioprocessing, chemical engineering, biological sciences, or acceptable equivalent combination of education and directly related work experience.
  • 10 years of directly related industry experience, including proven leadership
  • Experience in the biotechnology or pharma industry with a primary focus on GMP manufacturing operations for biologics, preferably with cell therapy products.

Knowledge of FDA, EMA, and ICH regulatory requirements will be appreciated



  • Outstanding interpersonal skills
  • Excellent organizational skills
  • Proven managerial and team interaction skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Risk based approach mindset


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