Head of Operations, Cell Therapy Facility

I am seeking a Head of Operations, for my client’s Cell Therapy Facility based in Ghent, Belgium. Heading up the Technical Operations team, this position will be responsible for cGMP operations for Clinical and Commercial Cell Therapy Manufacturing.

This individual will partner Technical Operations with other functions to produce a personalized cell therapy through safe and compliant manufacturing operations according to cGMP requirements.  They will support organization build, operations ramp-up of clinical production, and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained production.

The role will require proven leadership to drive effective communication, coordination and collaboration across relevant cross functional groups to ensure robust production, testing and release of product to patients. 

Major Responsibilities

• Leads, directs, coaches and develops an effective operations team for daily clinical production and strategically prepares for commercial supply of a CAR-T product
• Promotes a collaborative work environment focused on an EHS first mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvement
• Provides technical and managerial leadership in area of responsibility by effectively interfacing and collaborating with key stakeholders and functions
• Directs daily operations and supports activities to enable timely, successful disposition of product for patients 
• Leads and actively participates in all regulatory and internal audits of the facility 
• Oversees the hiring, development, and performance management of team
• Develops metrics to drive team results in areas of EHS, quality, compliance, cost, delivery and people

Requirements

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field
• 10+ years of combined experience in cGMP manufacturing, operations management, tech transfer, process and equipment validation and quality management, with a preference for cell therapy experience
• Minimum of 5 years of experience in a leadership role in Biologics and/or cell therapy operations
• Working proficiency in English and ideally Dutch
• Demonstrated ability to build effective and efficient teams and drive change within an organization
• Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow
• A history of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
• Communicates 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
• Capable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels
• Proven experience working and leading in a matrix environment
• Ability to lead with influence
• cGMP manufacturing, preferably cell therapy
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
• Strong analytical, problem solving and critical thinking skills 
• Technical transfer and process validation
• Project management
• Change management
• Operational excellence, continuous improvement and lean manufacturing 
• Excellent organizational and communication skills
• Transparent, Passionate, Fearless and Accountable

A competitive package is on offer, commensurate with the experience required of the ideal candidate. The role will be based in Ghent, with some flexibility of site and homes-based working.

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If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +44(0)1273 952176, or apply with your CV to arrange a confidential discussion.