Tech Transfer Specialist

PE Global is recruiting for a Tech Transfer Specialist for our biopharmaceutical client in Dublin. This is an initial 12-month contract, hybrid role.

The position requires effective cross-functional collaboration with external and internal partners including External and Internal Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Supply Relationship Management, External Manufacturing and Operations, Quality and Regulatory partners.

You will be responsible for:

• Developing and implementing TT Strategy including Process Validation, Control Strategy. This includes drug substance and drug product (biologic) and drug product (e.g. oral solid dosage)
• Leading technical gap assessment & ensuring implementation of any associated mitigation activities.
• Authoring and reviewing project related documentation. Reviewing approving supporting protocols and reports.
• Ensuring site specific Cleaning Validation and Media Fill Strategy (as applicable) is aligned with Alexion global requirements.
• Provide SME input to technical aspects of IR response. Providing support to Regulatory audits as needed.
• Support the implementation of TT and Validation best practices across the network, work closely with other members of the ATO TT and Validation team on implementation of improvements.

You will need to have:

• 6 years’ experience providing technology transfer project support to drug substance or drug product manufacturing.
• Proven ability to successfully manage Tech transfer programs at site level and corporate level in support of GMP operations.
• Comprehensive understanding of Technical/cGMP requirements for Tech Transfer activities.
• Ability to present and defend tech transfer topics during regulatory agency inspections.
• Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
• Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.

We would prefer for you to have:

• Bachelor’s degree in Science or Engineering, (or related field).
• Organized analytical thinker with strong attention to detail.
• Excellent oral and written communication skills, including technical writing.
• Ability to communicate technical and regulatory drivers with the proven capability of implementing TT projects.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV to paul.wheatley@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***