QC Analyst II

Description
Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.


With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.


Position Summary

The QC Analyst will be responsible for conducting cGMP testing of final products, in-process materials, raw materials, and stability samples. You will maintain laboratories, assist in writing and optimizing methods, perform method validation, and qualify lab equipment as needed.

Key Responsibilities

• Perform comprehensive testing on final products, in-process materials, raw materials, and stability samples.
• Execute a variety of testing methods including chromatography, spectroscopy, wet chemistry, and radionuclide essays.
• Complete and review test records with accuracy and attention to detail report any quality anomalies according to established protocols.
• Perform deviation and laboratory investigations as needed
• Draft data summaries including Certificates of Analysis (CofA) and stability summary tables.
• Update methods, technical reports, and investigations documentation
• Prepare testing reagents and maintain laboratory supplies and chemicals
• Conduct environmental monitoring (EM) sampling, incubation, and testing
• Assist in validation and/or development of analytical methods and techniques
• Participate in the qualification of QC laboratory equipment
• Package and send samples to conduct laboratories

Additional responsibilities as assigned
Profil souhaité
Qualifications

Education

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Experience

• Experience in a regulated laboratory environment, preferably in pharmaceuticals or biotechnology.

• Proficiency with a variety of HPLC, MS, and CE (Capillary Electrophoresis) methods
• Comprehensive understanding of cGMPs, proper documentation, and data integrity
• Strong analytical and organizational skills.
• Excellent written and verbal communication abilities
• Demonstrated ability to work independently in a team-based setting
• Capability to function effectively in a rapidly changing environment
• Skill in balancing multiple priorities simultaneously
• Flexibility to easily switch between multiple ongoing projects and adjust priorities based on business needs.

Work Environment

• Onsite in Brownsburg, IN