Quality Control Scientist

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.