Manufacturing Lead - Gene Therpay

Posted 22 September 2022
Salary 58000
LocationAmsterdam
Job type Permanent
Reference67541
Contact NameJames Hume

Job description

Introduction

This Manufacturing Lead opportunity is with a leading gene therapy company who are based in Amsterdam.  They are one of the leaders in the market because of their success in having the first approved therapy in Western world, first commercially licensed manufacturing facility and their effective AAV based technology.  They are seeking a person to lead both their upstream and downstream processing acitivites.  Working closely with the team to schedule their activities, train and develop their skill sets too.  Plus, work closely with the Associate Director as they look to increase capacity at this site and play a key role in this process.

This role will offer you

  • Lead the manufacturing team and this role is key in the delivery of products, their yield and quality.
  • Exposure to help you develop your own career.
  • This is an important role in their plans to grow the manufacturing operations, with influence on how this is achieved.
  • Drive the optimisation of existing processes and the adoption of new technologies.

You will be responsible for

  • Lead the manufacture of their products, manage documentation and compliance to GMP
  • Responsible for the scheduling of daily activities
  • Operate as the point of contact for all troubleshooting and escalation issues.
  • Oversight and execution of routine and critical plans including commissioning and validation.
  • Identify, raise and then execute process improvements.  Working with colleagues from other teams where necessary to achieve this.
  • Initiate and complete and deviations, CAPA’s etc.
  • Review and author SOP’s
  • Train, develop and motivate your team

 

You will bring the following

  • Hold a scientific or engineering degree.
  • Prior experience of GMP manufacture in Biologics / Biopharma / ATMP environment.
  • Experience of leading teams (small or large)
  • Experience of managing documentation as well as CAPA’s Deviations etc.

BioTalent Ltd are acting as an employment agency in relation to this opportunity. To find out more about this exciting opportunity, james.hume@biotalent.com with your CV.