Tech Transfer Specialist

Hobson Prior currently have an opportunity for a Tech Transfer Specialist to join a ground-breaking gene therapy organisation on a permanent basis located in Shannon.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be accountable for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Answerable for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• You will develop technical subject matter expertise in the technical support team and wider manufacturing operations.
• Project lead and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, launch and subsequent lifecycle management.
• Responsible for product lifecycle management activities including process validation of processes in line with ICHQ8-10.
• Management of change controls; providing impact assessments as a technical functional, coordinating input and support from development if required. Lead/support and/or coordinate the action plans.
• You will lead and provide technical support using established problem solving techniques for investigations into quality events, customer complaints and IMC actions. Provide technical recommendations, co-ordinate and execute CAPA's.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.

Requirements:

• Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio-pharmaceutical sciences.
• Extensive industrial experience in Pharma/Bio within a GMP regulated environment.
• 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.
• Excellent verbal and written communication skills, in English.
• Ability to present effectively to groups.
• Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.
• Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.