Vp of Operations
Il y a 5 mois
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.
**Role & Responsibilities**:
- Be responsible for Cellistic P&L (Revenue, CAPEX and OPEX budget)
- Be accountable for the site of Mont St Guibert
- Design and implement the Operations strategy of Cellistic
- Manage the design, construction, staffing, qualification, start-up, validation and regulatory approval of manufacturing capacities and capabilities
- Be responsible for all aspects of cGMP activities for a Clinical Cell Therapy Manufacturing plant from raw material procurement through product release.
- Lead and ensure strong delivery for multiple departmental functions (production, quality control, quality assurance, technical services, EHS, CAPEX).
- Define and execute best practice manufacturing vision, strategy, policies, processes and procedures to aid and improve business performance.
- Be responsible for developing the appropriate organizational structure, resource plans and culture to support the business objectives.
- Set Cellistic operations objectives and monitor ongoing progress and performance. Report on activities on a regular basis to the Executive team.
- Ensure Cellistic operations remains in compliance with GxP & EHS requirements as well as with company policies, Standard Operating Procedures (SOPs) and all applicable laws.
- Contribute to new business initiatives and projects and review and communicate the impact on manufacturing activities.
- Provide clear leadership and vision, inspire and motivate staff to achieve excellence and mentor them as they develop new skills.
- Drive a collaborative work environment that focuses on creating and maintaining a strong quality, compliance and continuous improvement culture within the organization.
- Prepare and maintain fully engaged as well as talented workforce in entire organization and ensure robust succession planning.
- Build long term, trusting relationships with internal and external stakeholders, customers, business partners and authorities.
**Qualification & Experience**:
- University degree in Biology, Bioengineering, Pharmacy, or other relevant discipline.
- 15 years of combined experience in cGMP manufacturing, operations management, tech transfer, process, analytical and equipment validation and quality management.
- Minimum of 10 years of experience in a leadership role.
- Minimum of 5 years of experience in cell therapy industry.
- Experience in CDMO is a plus.
- Demonstrated ability to build cohesive, high performing teams and drive change within an organization.
**Skills & Competencies**:
- Experience in CDMO is a plus.
- Demonstrated ability to build cohesive, high performing teams and drive change within an organization.
- Outstanding leadership, strategic and organizational abilities. Hands-on capabilities.
- Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels.
- Customer-oriented mindset
- Communicate effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations.
- Strong people management skills.
- Strong presentation skills.
- Capable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment.
- Knowledge of industry’s technologies, legal rules and guidelines.
- Compliance and safety-minded culture.
- Self-motivated, enthusiastic personality, team player.
- 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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