Production Manager

il y a 2 semaines

MontSaintGuibert, Belgique Cellistic Temps plein

The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading research facility to overcome the complexity and challenges of iPSC lineage specification. We will know we have succeeded when we can reliably and rapidly generate cell products that consistently produce positive outcomes in patients.

**Responsibilities**:
The Production Manager is responsible for:
i) Operational management
- Planning and capabilities
- Communication
- People management
- Budget

ii) Compliance of the Production
- QMS
- Zone, personnel and equipment
- Audit readiness

iii) Continuous Improvement
- KPIs
- Optimize efficiency of Production

**Management and planning of the Production **Team**:

- Plan, coordinate, manage and control the day-to-day production activities:

- Organize and routinely manage production capacities and capabilities to ensure successful execution of Cellistic ATMPs products under development and through routine clinical manufacturing.
- Act as primary production point of contact for the other teams inside or outside the organization. Develop and drive a clear and comprehensive communication channel within the team and with other teams interacting directly with the Production Unit.
- Manage a team of production technicians and specialists. People development and management responsibilities to include new hires selection and onboarding, regular feedback and skills development, documentation and delivery of annual performance reviews, on-going coaching and counseling, determination of necessary resources and implementation of strong team spirit.
- Establish highly effective technical capability within the team.
- Ensure that the team efficiently deliver on their KPI’s, in respect of safety & quality standards and business deadlines
- Budget management and control of the Production team:

- Annual preparation, monthly review and management of budget
- Approval of Production-related cost center expenses (including invoice charges) in line with budget

**Compliance of the Production Unit with EHS & Quality standards**:

- Ensure production areas and operations remain in compliance with current Good Manufacturing Practices and safety requirements.
- Ensure compliance to SOPs, Batch Records, Quality Systems (Deviations, Change Controls, Corrective Action /Preventative Action), and Protocols.
- Represent production during internal and external audits and acts as a Cellistic Representative towards visitors and local authorities.
- Ensure that production personnel are adequately trained and are sufficiently knowledgeable in safety matters and GMP to perform their assigned duties.

**Continuous improvement of the Production Unit**:

- Ensure that the facility & equipment is functioning properly. In collaboration with the infrastructure department, define investments and support timely equipment qualification as well as corrective and preventive maintenance.
- Participate in the design, construction, staffing, qualification, start-up, validation and regulatory approval of production capacities and capabilities in order to meet the objectives of the company.
- Set and monitor metrics to drive continuous improvement initiatives and ensure that decisions are based on facts and measurement trends.

**Qualification & Experience**:

- University degree in Biology, Bioengineering, Pharmacy, or other relevant discipline.
- Minimum of 10 years of directly related GMP manufacturing experience in pharmaceutical or biotech industry.
- At least 5 years of aseptic GMP manufacturing experience
- Successful experience in creating and managing teams
- Experience with cell culture

**Skills & Competencies**:

- Excellent interaction & communication skills, required to work across departments
- Highly developed organizational skills
- Strong influence and leadership skills, with a desire to lift up people
- Work precisely according to procedures, rules, and regulations
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
- Can do attitude and Hands-on approach
- Self-motivated, enthusiastic personality, team player
- Problem solver
- Languages: Fluent in English and French

**Job Location**:Mont Saint Guibert, Belgium

**Position Type**: Full-Time

**Start Date**:Immediately

We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.

**Interested?**:

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