Responsibilities

• Carry out Technology Transfer of new products from Process Development to Manufacturing (Plasmids and Viral Vectors).
• Support the organisation and processes for project management and technical support in product lifecycle management activities including validation of manufacturing processes and methods in line with ICHQ8-10.
• Develop technical subject matter expertise in the technical support team and wider manufacturing operations.
• Project leadership/management and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, launch and subsequent lifecycle management.
• Lead and/or provide technical support using established problem solving techniques for investigations into quality events, customer complaints and IMC actions.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
• Manage and/or support process and analytical transfers for any transfers from development, CMOs and partners into MeiraGTx manufacturing/testing facilities.

Job requirements:

• Scientific Degree or equivalent, preferably with a higher qualification in bio-pharmaceutical sciences.
• Extensive experience in Pharma/Bio
• Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
• Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment and successfully gaining approval and launching new products commercially.
• Excellent communication skills.
• Knowledge of the Regulatory compliance requirements within Europe and the USA.
• Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma tools. Ability to manage, multiple, cross functional projects to deliver against key project milestones and deadlines.
• Experience of managing workload of small teams to meet deadlines.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.