Senior Quality Control Analyst

Context

Nuclear medicine has advanced significantly in recent years with the development of radiotherapeutics for cancer treatment. These radiotherapeutics deliver radioisotopes to cancer cells, where their decay emits radiation that selectively destroys tumors. Among these therapeutic isotopes, alpha-emitting Actinium-225 (Ac-225) is highly promising and is being utilized by pharmaceutical companies to develop new radiotherapeutics.

A key challenge is producing high-quality Ac-225 in large quantities. To address this, SCK-CEN and IBA have combined their expertise to establish PanTera, a company dedicated to producing Ac-225 and making it accessible to the pharmaceutical industry.

Purpose of the Position

PanTera is launching a new production facility to manufacture large quantities of Ac-225. This facility includes a specialized Quality Control (QC) laboratory responsible for ensuring the quality of Ac-225 produced. The QC lab will perform analyses to confirm that Ac-225 meets specifications for safe patient administration, adhering to current Good Manufacturing Practices (cGMP). The lab will employ advanced techniques such as gamma spectrometry and ICP-MS.

As a Senior QC Lab Analyst, you will work within the QC team under the direct supervision of the QC Manager. Your role will involve supporting the startup of new equipment, developing analytical methods (e.g., ICP-MS, gamma spectrometry, and Ac-225 labeling experiments), and contributing to equipment qualification and method validation. Given the cGMP-regulated environment, familiarity with GMP standards is essential.

We seek a candidate with a strong analytical mindset, excellent organizational skills, and a proactive, flexible approach to teamwork. The candidate should be eager to learn new analytical techniques and comfortable working with radioactive materials.

Key Responsibilities

• Qualify equipment and develop methods for analyzing Ac-225 solutions using specialized techniques (e.g., ICP-MS, gamma spectrometry, endotoxin determination).
• Analyze in-process control samples, starting materials, and Ac-225 batches using techniques such as gamma spectrometry and ICP-MS.
• Ensure all qualified equipment and analytical methods comply with cGMP regulations.
• Report data according to standard protocols.
• Manage quality control of raw materials (incoming goods).
• Perform (re)calibration and maintenance of laboratory equipment.
• Write and maintain Standard Operating Procedures (SOPs).
• Collaborate with subcontractor analytical laboratories as needed.

Profile

• Master’s degree in Analytical Chemistry or a related field.
• Proven experience with ICP-MS.
• Experience in radiochemical analysis.
• Familiarity with a GMP environment.
• Willingness to learn new analytical techniques and work under strict regulatory requirements.

Skills and Competencies

• Proficiency in specialized techniques such as ICP-MS and gamma spectrometry.
• Strong analytical skills with a keen eye for detail.
• Ability to work independently and collaboratively within a team.
• Quick learner, adaptable to a fast-paced and evolving environment.
• Commitment to adhering to high standards, cGMP, and regulatory requirements.

Our Offer

• A unique opportunity to work in a cutting-edge environment, contributing to the production of critical radiotherapeutics for cancer treatment.
• A collaborative workplace with supportive colleagues who value teamwork.
• An entrepreneurial atmosphere within a scaling company.
• A mission-driven organization focused on improving patients’ quality of life.