Proclinical is seeking a Senior QC Analyst to permanently join a dynamic team. This role focuses on supporting the startup of a new production facility dedicated to manufacturing Ac-225, a critical radiotherapeutic for cancer treatment. You will play a key role in ensuring the quality of Ac-225 through advanced analytical techniques such as gamma spectrometry and ICP-MS, while adhering to current Good Manufacturing Practices (cGMP). This is an exciting opportunity to contribute to cutting-edge innovation in a fast-paced, regulated environment.
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 advanced analytical methods.
* Ensure all qualified equipment and analytical methods comply with cGMP regulations.
* Report data according to standard protocols.
* Manage quality control of raw materials and incoming goods.
* Perform recalibration and maintenance of laboratory equipment.
* Write and maintain Standard Operating Procedures (SOPs).
* Collaborate with subcontractor analytical laboratories as needed.
Key Skills and Requirements:
* Master's degree in Analytical Chemistry or a related field.
* Proven experience with ICP-MS.
* Experience in radiochemical analysis.
* Familiarity with GMP standards and regulatory environments.
* Willingness to learn new analytical techniques and work with radioactive materials.
* Proficiency in specialized techniques such as ICP-MS and gamma spectrometry.
* Strong analytical skills with attention to detail.
* Ability to work independently and collaboratively within a team.
* Adaptability to a fast-paced and evolving environment.
If you are having difficulty in applying or if you have any questions, please contact Jordan Kiely at j.kiely@proclinical.com.
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