Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Quality Control Lead is a site-based role responsible for coordinating and performing Quality Control activities supporting clinical and commercial radiopharmaceutical production at the Wilkes-Barre facility. The role provides technical expertise in analytical method development and validation, specifications, stability programs, routine testing, laboratory investigations, equipment qualification, and GMP documentation.

During the facility’s build and validation phase, the Quality Control Lead will support the commissioning, qualification, validation, and operational readiness of the QC laboratory. Working under the direction of the Quality Director, Manufacturing Expansion & Readiness, the role will help implement the methods, procedures, equipment, documentation, and external laboratory support required to transition the facility into routine GMP operations.

This role is on-site 5 days a week at our Wilkes-Barre, PA production facility.

Key Accountabilities

Quality Control and Analytical Support

Coordinate and perform analytical method development, validation, transfer, stability testing, and routine QC testing for clinical and commercial radiopharmaceutical products.
Draft and maintain analytical methods, specifications, protocols, reports, and QC
Review analytical data and laboratory records for accuracy, completeness, and compliance with cGMP

Laboratory Operations

Coordinate laboratory equipment qualification, calibration, maintenance, and
Maintain appropriate controls for laboratory materials, reagents, consumables, and reference
Coordinate testing performed by external laboratories and review associated

Investigations and Compliance

Lead or support assigned deviations, OOS/OOT investigations, CAPAs, change controls, and risk
Ensure assigned QC activities comply with approved procedures, data-integrity standards, radiation-safety requirements, and applicable regulations.
Support internal audits, external audits, regulatory inspections, and customer-complaint

Site Readiness and Improvement

Support commissioning, qualification, validation, and operational readiness of the Wilkes-Barre QC
Identify technical or compliance gaps and recommend improvements to analytical methods, equipment, documentation, and laboratory processes.
Provide technical guidance and training to personnel and external partners supporting QC

Education and Experience

Bachelor’s degree in radiochemistry, chemistry, pharmacy, biochemistry, or a related scientific discipline required
5+ years’ experience in pharmaceutical or biotechnology Quality Control, analytical development, or Good Manufacturing Practices (GMP) laboratory operations
Experience with analytical chemistry techniques, including chromatography and other relevant testing methods
Experience with analytical method development, validation, verification, or
Experience supporting stability programs, specifications, deviations, OOS/OOT investigations, CAPAs, and laboratory change controls.
Working knowledge of pharmaceutical Quality Systems and applicable cGMP requirements, including 21 CFR Parts 210 and 211.
Experience supporting facility or laboratory commissioning, qualification, validation, or operational readiness
Experience coordinating work with contract laboratories or external testing providers
Radiopharmaceutical, radiochemistry, or radioactive-material handling experience

Ability to provide technical guidance and coordinate activities without formal people-management authority.