|Location||Kingdom of Belgium|
|Discipline:||Quality Assurance, Regulatory Affairs|
|Salary:||£Salary and benefits to be discussed on application|
|Contact name:||Katie Dunbar|
|Published:||about 1 month ago|
|Expiry date:||19 June 2021|
Are you an experienced Senior Leader with a Technical Operations background in Biotechnology?
RBW Consulting is the sole agent for a career-defining role with a US Biotech as they open up operations in the EU, expanding their pipeline of products which includes CAR-T cell therapy.
At this pivotal point in their growth, our client needs a senior leader who has the capability, network, and people skills to establish a core business with Europe and be the cross-functional leader of this team.
Key for this role will be effective relationship building, hiring and rooting teams across Regulatory, Process Development, Clinical Operations, Commercial Operations, Quality, Finance, HR and Legal.
This General Manager will be responsible for all aspects of cGMP operations for a Clinical and Commercial Cell Therapy Manufacturing plant from raw material procurement through product release.
Build and lead effective operations and support area teams in preparation for commercial supply of a CAR-T product
Work closely with the collaboration partner to ensure facility design.
Provide technical and managerial leadership in all cGMP-related areas of responsibility. Leads and ensures strong delivery for multiple departmental functions (procurement, planning, warehouse, operations, technical support groups, engineering, supply chain etc)
Drives a collaborative work environment that focuses on creating and maintaining a strong quality and continuous improvement culture within the organization
Ensures that standards for product quality, manufacturing costs and throughput, equipment and operator performance, employee safety and housekeeping standards are established, monitored and maintained
Build a strategy to develop existing talent, continue to build bench strength in the entire operations organization and ensure robust succession planning
Essential Qualifications and Experience:
B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field
15+ 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
At least 5 years of experience in a leadership role in Biologics and/or cell therapy operations
Demonstrated ability to build effective and efficient teams and drive change
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
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 and ensure strong succession planning
Communicates effectively with people at all levels, including the ability to understand their priorities, and 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
Roles like this are extremely rare but offer phenomenal opportunities to bring a career’s worth of capability together into one demanding yet hugely rewarding project.
Please apply or contact firstname.lastname@example.org for a confidential conversation to find out more.
Salary and benefits to be discussed on application
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