Ardena

www.ardena.com

1 Job

559 Employees

About the Company

We are a global provider of drug development and discovery services, encompassing drug substance, drug product, bioanalysis, and CMC regulatory services across small molecules, large molecules, and nanomedicines. Our six international locations offer comprehensive CDMO and BioAnalytical CRO services to a wide range of clients worldwide.

We recognize the intricate challenges associated with advancing a promising molecule from the laboratory to the patient. Our multidisciplinary team is eager to collaborate with you throughout your development process, utilizing specialized technologies to optimize formulation and manufacturing. We possess extensive expertise in spray drying, hot melt extrusion, and lipid-based formulations that enhance bioavailability and solubility. Additionally, our capabilities include polymeric, metal, and lipid nanoparticles for advanced drug delivery applications, as well as high-potency and controlled substance handling for highly specialized therapeutics.

At Ardena, all work adheres to the appropriate regulatory standards as you progress through the clinical development pathway. Please contact us to further discuss your clinical and scientific objectives and explore how we can work together.

Listed Jobs

Company Name: Ardena
Job Title: Analytical Scientist
Job Description: Job title: Analytical Scientist Role Summary: Conducts development, validation, and routine quality control analyses of oligonucleotide and biological products under GMP, ensuring analytical methods support early‑phase clinical material production. Expectations: Deliver accurate, compliant analytical data; serve as subject‑matter expert; mentor junior staff; collaborate across cross‑functional teams; maintain regulatory documentation and process improvements. Key Responsibilities: - Prepare and perform development and QC analyses per SOPs. - Develop, install, and validate chromatographic and assay methods (HPLC, UPLC, GC, dissolution, Karl Fisher, UV‑VIS, IR). - Troubleshoot analytical challenges and propose solutions. - Document and report results in line with GMP. - Plan, organize, and control analytical packages independently. - Contribute to procedural documents and lab management improvement projects. - Mentor and train associate scientists in analytical techniques. - Coordinate timelines with project management and lab management. - Support technical discussions with contract clients and regulatory teams. - Initiate and document investigations and non‑conformances. Required Skills: - Advanced knowledge of chromatography (HPLC, UPLC, GC), dissolution, Karl Fisher, UV‑VIS, IR, and biological assay development. - Expertise in oligonucleotide chemistry and biological drug product attributes. - Experience in small‑molecule analytical development preferred. - Proficiency in method validation, GMP compliance, data analysis, and documentation. - Strong analytical mindset, problem‑solving, and stress resilience. - Excellent written and spoken English. - Team‑player, flexible, and proactive. Required Education & Certifications: - PhD (or equivalent doctoral degree) in a relevant scientific discipline. - ≥3 years professional laboratory experience in regulated QC/analytical development. - Demonstrated experience working in a GMP‑regulated environment.