Quality Control Scientist

ARTBIO

Oslo, Norway

Summary

We're seeking a QC scientist who will be responsible for technically designing, managing, and executing lab-based experiments for the development of quality control methodologies for the manufacturing of drug candidates in a network that can support clinical trials, that can be ready for commercial deployment. The successful candidate will be technically proficient in analytical sciences, specifically radioHPLC, and aid in developing a new analytical platform focusing on Pb212 and Pb212-drug conjugates.

Responsibilities

Plan, execute, and manage experimental assays to support analytical development in a laboratory-based environment;
Drive the development, optimization, and validation of analytical methods for drug substances and drug products;
Appropriately record and report incoming data and development decisions;
Collaborate with cross-functional teams to aid in ensuring smooth technology transfer of analytical methods from research to development and manufacturing sites;
Work closely with cross-functional teams, including formulation development, pre- and non-clinical, and regulatory affairs, to ensure alignment of analytical activities with overall project goals;
Evaluate, select, and implement new analytical instruments and equipment to enhance the capabilities of the analytical laboratory;
Ensure the proper maintenance, calibration, and validation of analytical instruments;
Stay in-the-know of industry regulations and guidelines related to analytical methods and instrumentation;
Ensure compliance with regulatory requirements in all analytical activities and documentation;
Drive the resolution of complex analytical challenges and troubleshoot issues related to method development, validation, and transfer;
Implement continuous improvement initiatives to enhance the efficiency and effectiveness of analytical processes;
Ensure accurate and timely documentation of analytical activities, including method development reports, validation protocols, and technical reports;
Prepare and deliver technical presentations to internal and external stakeholders;
Ensure compliance with all relevant regulations, standards, and guidelines, including those relating to quality, safety, and environmental impact for our CDMOs, internal R&D and own projects;
Identify and implement process improvements to increase efficiency, reduce costs, and enhance the safety and quality of the products and services provided by ARTBIO.

Qualifications & Experience

M.Sc. in Analytical Chemistry, Biotechnology, or a related field;
Minimum of 2 years of experience in the radiopharmaceutical industry with a proven track record in method development;
Experience working with radioactivity and radioactive sources;
Skills and experience in use of chemical analytical methods, especially RadioHPLC. Skills and experience in GC, spectroscopy, and LC-MS, TLC, and sterility and microbiological methods are a plus;
Knowledge of regulatory requirements for pharmaceuticals (especially radiopharma) in US and EU is a bonus;
Ability to design and execute experiments while utilizing multivariate analysis in all development activities;
Excellent communication skills and the ability to collaborate effectively with cross-functional teams;
Proven track record in technical and scientific writing;
Excellent organizational and project management skills, with the ability to prioritize and multitask effectively;
Written and verbal fluency in English.

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