IVD Development and Validation Team Leader
Location: Craigavon
Hours: 37.5 Hours Per Week with flexible working hours available
Salary: Competitive
Business Unit: Diagnostic Services
Open To: Internal and External Applicants
Ref No.: HRJOB11132
The Role
Almac Diagnostics Services is seeking a dynamic and experienced Team Leader to oversee our IVD Development and Validation team. You will play a pivotal role in managing the day-to-day operations of our assay development pipeline, ensuring projects are delivered efficiently, on time, and in compliance with regulatory standards.
As Team Leader, you will provide technical and scientific leadership, implement new technologies, and deliver innovative solutions to meet client needs. You will be responsible for the design and development of assays across a range of platforms, collaborating with various teams to ensure products meet their intended use and quality requirements.
Key Responsibilities
Independently manage all aspects of assay development and validation for non-interventional assays and verification of approved IVD devices.
Support the development and management of Investigational Use Only (IUO) Clinical Trial Assays and Companion Diagnostic Assays.
Design technical solutions based on intended assay use and regulatory pathways.
Compile technical documentation in compliance with Design Control and Risk Management procedures.
Plan and deliver analytical validation studies in line with quality and regulatory standards.
Oversee user acceptance testing and collaborate with software development teams.
Ensure successful
