Tech Transfer Lead

Summary:
Our client is a pharmaceutical company based in East Cork looking for a Technology Transfer Lead to lead commercial-to-commercial technology transfer at their receiving site. The successful candidate will ensure the delivery of a successful technology transfer programme within budget and schedule. This role covers the entire transfer lifecycle, from initial planning and risk assessment to execution and post-transfer evaluation.

Responsibilities:

• Co-ordinate, lead and improve the technology transfer process as part of a multi-disciplinary team at the receiving site.
• Deliver successful technology transfer(s) in line with current regulatory guidelines and industry best practice guidelines.
•  Coordinate the development of documentation for the receiving site.
• Collaborate closely with the sending site to align transfer activities and address any cross-site challenges.
• Support the scheduling of qualification activities.
•  Identify and mitigate business and quality-related risks associated with technology transfer activities in conjunction with relevant stakeholders.
• Work collaboratively with project support groups (e.g. automation, construction, engineering, end user, quality) and their management to influence decisions.
• Coordinate with and assist other technology transfer activities as needed to facilitate completion of work.
• Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard.
• Monitor progress and performance, providing regular updates to stakeholders.

Qualifications & Experience:

• Bachelor’s or Master’s degree in a relevant field (e.g., Chemical Engineering, Pharmaceutical Sciences).
• 5+ years’ experience in the Biotech/Pharmaceutical industry supporting manufacturing and technology transfer.
• Experience and proficiency using Quality Systems e.g., electronic document management systems, change management and deviation management.
• Proven experience in successful technology transfer, preferably in a commercial setting.
• Previous experience with knowledge management and documentation practices.
• Previous experience managing complex projects.
• Experience in executing projects in a fast-paced dynamic environment.
• Excellent verbal and written communication skills with both technical and non-technical staff.
• Knowledge of up-to-date regulations and guidelines (ICH, ASTM, FDA, ISPE, Eur.Ph), and modern practices.
• Excellent communication skills, both within projects and to report to important stakeholder groups.
•  Willingness to travel internationally as required.