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Quality Control Scientist

ARTBIO

ARTBIO

Quality Assurance
Oslo, Norway
Posted on Friday, July 5, 2024
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 & Education

  • 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.


About Us

ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs with lead program AB001 currently in first in human trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital. For more information, visit www.artbio.com, and follow us on LinkedIn and Twitter.

As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration.

EEO Statement

ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.