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Quality Control Scientist

5 months ago

Oslo, Norway Work In Biotech Full time

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.