Manager / Sr Manager Gmp Manufacturing

Sangamo Therapeutics France

**_Manager / Sr Manager GMP Manufacturing _**

**Contract**:Permanent

**Department**:Manufacturing

**Location**:Valbonne, France

**Reporting to**: Site lead (dotted line to the VP external manufacturing)

**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**:

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