QC Analyst II

Orano

CDIPrésentielConfirmé (3–5 ans)

À propos du poste

Orano Med, subsidiary of Orano USA, is developing innovative targeted alpha therapies based on lead-212 extraction and purification to treat cancer while minimizing impact on healthy cells. As QC Analyst II, you will play a critical role in ensuring the quality and safety of pharmaceutical products in a highly regulated cGMP environment. This position is essential to Orano Med's mission of becoming a leader in nuclear medicine therapies. You will conduct comprehensive testing of final products, raw materials, and stability samples using advanced analytical techniques including HPLC, mass spectrometry, and capillary electrophoresis. Your work directly supports the development of life-saving treatments for cancer patients. The role combines laboratory expertise, regulatory compliance, and attention to detail in a dynamic, fast-paced biotechnology setting where precision and integrity are paramount.

Vos missions

Perform comprehensive cGMP testing on final products, in-process materials, raw materials, and stability samples
Execute analytical testing methods including HPLC, mass spectrometry, capillary electrophoresis, and wet chemistry
Complete and review test records with accuracy and report quality anomalies according to established protocols
Draft Certificates of Analysis and stability summary tables for regulatory compliance
Conduct environmental monitoring sampling, incubation, and testing
Assist in validation and development of analytical methods and techniques
Participate in qualification of QC laboratory equipment
Prepare testing reagents and maintain laboratory supplies and chemicals

Profil recherché

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
Experience in regulated laboratory environment, preferably pharmaceuticals or biotechnology
Proficiency with HPLC, MS, and capillary electrophoresis methods
Comprehensive understanding of cGMPs, proper documentation, and data integrity
Strong analytical and organizational skills
Excellent written and verbal communication abilities
Ability to work independently and as part of a team
Capability to manage multiple priorities and projects simultaneously

Un plus si vous avez

Experience in radiopharmaceutical or nuclear medicine environments
Familiarity with laboratory information management systems (LIMS)
Knowledge of stability testing protocols
Experience with deviation and laboratory investigations

Compétences clés

cGMPHPLCMass SpectrometryAnalytical MethodsQuality ControlData IntegrityLaboratory ManagementPharmaceutical Testing

À propos de Orano

Orano

Nucléaire

10 000+ employésChâtillon, France

Orano, anciennement Areva NP, est un groupe industriel spécialisé dans le cycle du combustible nucléaire : extraction d'uranium, conversion, enrichissement, fabrication de combustible, traitement et recyclage des matières nucléaires. Présent dans 17 pays avec environ 17 000 collaborateurs, Orano est un acteur stratégique de la filière nucléaire civile mondiale et un partenaire incontournable des exploitants de centrales.

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