Quality Control Lead

telixus; United States; Sur place; USD 110 000 - 170 000; Plein temps

Résumé du poste

Telix Pharmaceuticals is seeking a Quality Control Lead for the Wilkes-Barre facility. You will coordinate and perform QC activities supporting clinical and commercial radiopharmaceutical production, providing expertise in method development, validation, specifications, stability programs, and GMP documentation.

Reporting under the Quality Director, you will help implement methods, equipment, and documentation to transition the site into routine GMP operations, ensuring data integrity,

Qualifications

• Bachelor’s degree in a radiochemistry, chemistry, pharmacy, biochemistry, or related field is required.
• Experience in pharmaceutical or biotech Quality Control, analytical development, or GMP lab operations is needed.
• Experience with analytical chemistry techniques including chromatography and related methods is expected.
• Familiarity with 21 CFR Parts 210 and 211 and current GMP guidelines is required.

Responsabilités

• Coordinate analytical method development, validation, transfer, stability testing, and routine QC testing for clinical and commercial radiopharmaceuticals.
• Draft and maintain analytical methods, specifications, protocols, reports, and QC records.
• Review analytical data and lab records for accuracy and compliance with cGMP.

Formation

Bachelor's degree in radiochemistry, chemistry, pharmacy, biochemistry, or a related scientific discipline

Description du poste

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.

Key Accountabilities:

• 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.

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected