Senior Analytical Scientist

2 days ago

Durham, North Carolina, United States Cambrex Full time
Job Summary

We are seeking a highly skilled and experienced Senior Analytical Scientist to join our team at Cambrex. As a key member of our analytical team, you will be responsible for executing analytical methods, providing general analytical support, and leading initiatives to enhance operations.

Key Responsibilities
  • Develop and evaluate methodologies, design and implement experiments, and execute analytical methods for in-process control, release testing, and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
  • Apply prior knowledge to accurately interpret structural data and apply advanced scientific/technical reading, writing, and verbal communication skills.
  • Develop and maintain compliant records with little or no supervision and participate in experimental design, including development of methods and testing requirements to demonstrate method suitability.
  • Lead and develop other team members, provide input on SOPs and client questions, and effectively and routinely provide training.
  • Participate in group and project meetings, attend seminars as required, and participate in and comply with all current safety, health, and environmental programs.
Requirements
  • B.S./B.A. Chemistry with 14+ years of experience in related industry or MS with 10+ years related experience or PhD with 6+ years related experience.
  • Working knowledge of experimental design, including chemistry supporting method development, and good grasp of advanced scientific/technical reading, writing, and verbal communication skills.
  • Regularly conceives and applies innovative, technical solutions to a variety of problems and operates with substantial latitude for independent actions and decisions relating to technical problems and procedures.
  • Subject matter expert in one or more instruments (i.e. GC, LC, dissolution, TGA/DSC) and able to comply to SOPs and have understanding of regulatory compliance.
  • Strong understanding of current FDA and cGMP regulations, strong knowledge of chemistry and scientific calculations, and hands-on experience in analytical techniques such as HPLC, GC, etc.
What We Offer

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you are a motivated and experienced analytical scientist looking for a new challenge, please submit your application.

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