MS&T Senior Tech Transfer Specialist

Tandem Project Management Ltd.; Leinster; On-site; EUR 70,000 - 95,000; Full time

Job summary

A leading biopharmaceutical company in Meath seeks a MS&T Senior Tech Transfer Specialist. The role involves leading technology transfers, ensuring compliance with regulatory standards, and acting as an SME for process investigations. Suitable candidates will have a relevant technical degree and extensive experience in the biologics sector.

Qualifications

• Minimum 6 years in a biologics drug substance environment.
• Experience in technology transfers for clinical or commercial biologics.
• Process validation and cleaning validation experience desired.

Responsibilities

• Lead technology transfer and process validation programs.
• Act as Subject Matter Expert for process investigations.
• Optimize process equipment and develop breakthrough solutions.

Skills

Risk Management

Technical Expertise

Process Optimization

Education

Bachelor’s Level 8 degree in a technical field

Tools

Automated Systems

Job description

Summary:
Our client, a biopharmaceutical company located in Meath, is looking for a MS&T Senior Tech Transfer Specialist. The ideal candidate will be responsible for the participation in and leading of key technology transfers activities, in support of clinical and commercial new product introduction projects.

Responsibilities:

• Development of strategies for and support in the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
• Acting as process Subject Matter Expert in the support of process investigations.
• Use of risk management techniques to assess strategies, prioritize activities and initiatives.
• Lead other significant business critical projects on site associated with new product introduction and site capability build.
• Acting as system owner and Subject Matter Expert (SME) to support investigations and using risk management techniques to prioritize activities and initiatives.
• Ongoing optimization of process equipment and development of future breakthrough business solutions.

Qualifications & Experience:

• Bachelor’s Level 8 degree in a technical field (e.g. Engineering, Science or equivalent), with experience in the biotechnology or pharmaceutical industry.
• Minimum of 6 years in a biologics drug substance environment.
• Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
• Experience in technology transfers for clinical or commercial biologics strongly desired.
• Experience with automated systems highly desired.
• Process validation and cleaning validation experience desired.