Senior Technical Transfer Specialist, Cork
Client:
Location:
Cork, Ireland
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
1b232da48efc
Job Views:
9
Posted:
06.02.2025
Expiry Date:
23.03.2025
Job Description:
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through in-house training and mentorship to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are met.
Overview:
A fantastic opportunity has arisen for a Senior Technical Transfer Specialist to join our growing Engineering team. You will lead, collaborate, and facilitate activities (e.g., scale-up, PPQ batch manufacture, license submissions, technical troubleshooting, and audit readiness) for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to the Vaccines Integrate Process Team (IPT).
Requirements
Responsibilities:
* Ensure the highest Quality, Compliance, and Safety standards primarily with Technology Transfer but relating to all activities.
* Work within a team to enable the team’s performance within the Vaccine Technology Transfer group in the Technical Operations Dept.
* Responsible for the technical transfer and scale-up of a new process into Vaccines IPT.
* Input into/lead technical planning and decisions for the Vaccines IPT to ensure the supply of high-quality products through tactical planning and execution of production schedules.
* Technical Review, ownership of, and approval of Change Control, Quality Notification, deviation, and investigation records as required.
* Benchmark and remain current with the development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
* Stakeholder management of multiple decision-makers, corporate colleagues, cross-functional teams by demonstrating the ability to maintain and strengthen trust relationships with people at all levels.
Skillset & Qualifications:
* Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
* Project management qualification such as Project Management Professional is desirable.
* Preference for Lean Six Sigma qualification or experience of application of Lean principles.
* > 6 years’ experience in a biopharmaceutical/vaccines environment.
* Experience in leading projects; leading technical projects is a distinct advantage.
* Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
* Demonstrated knowledge in one or more pharmaceutical or Biopharmaceutical manufacturing operations (e.g., manufacturing operations, technology, validation, engineering, quality).
* Demonstrated successes in a cross-functional team environment, such as project teams.
* Demonstrated high level of problem-solving and facilitation skills.
* Stakeholder management of multiple decision-makers, colleagues, peers, and cross-functional teams.
* Experience in an FDA / HPRA Regulated production environment.
#LI-AM1
#J-18808-Ljbffr