JOB SUMMARY:

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.

ESSENTIAL FUNCTIONS:

• 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

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

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

OTHER REQUIREMENTS:

• 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

Pour postuler, merci de nous envoyer les CV + lettre de motivation via notre site : https://www.sangamo.com/careers/job-opportunities