- 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.
- 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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Quality Control Scientist - Oslo, Norge - Work In Biotech
Beskrivelse
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
Qualifications & Experience
