Senior Analytical Scientist

4 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 development team, you will be responsible for executing analytical methods, providing general analytical support, and collaborating with clients to discuss data and methods.

Key Responsibilities
  • Execute analytical methods for in-process control, release testing, and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
  • Develop and evaluate methodologies, design and implement experiments, and apply prior knowledge to accurately interpret structural data.
  • Collaborate with clients to discuss data and methods, and provide training and mentorship to other employees.
  • Participate in experimental design, including development of methods and testing requirements to demonstrate method suitability.
  • Maintain compliant records and write technical documents with assistance.
  • Participate in compliance meetings and ensure that client requests are within the boundaries of compliance.
  • Perform and review data analysis, draft reports, and identify and troubleshoot analytical problems.
  • Lead a sample project with assistance and participate in client-level meetings with approval.
  • Develop and implement new methods and technologies to enhance operations, and maintain a clean and safe work-space.
  • Compile, maintain, interpret, and extrapolate data on results of analysis and communicate these results to supervisors.
Requirements
  • Bachelor's degree in Chemistry with 12+ years of experience in related industry or Master's degree with 8+ years of experience or Ph.D. with 4+ years of experience.
  • Working knowledge of experimental design, including chemistry supporting method development.
  • Good grasp of advanced scientific/technical reading, writing, and verbal communication skills.
  • Regularly conceives and applies innovative, technical solutions to a variety of problems.
  • Effective independent researcher and able to articulate and evaluate project concepts and strategy.
  • Subject matter expert in one or more instruments (i.e., GC, LC, dissolution, TGA/DSC) and able to comply with SOPs and have understanding of regulatory compliance.
  • Strong understanding of current FDA and cGMP regulations, and strong knowledge of chemistry and scientific calculations.
  • Hands-on experience in analytical techniques such as HPLC, GC, etc., and strong computer skills.
  • Ability to operate laboratory equipment and computers, and ability to take direction from experienced scientists and contribute in a team.
  • Good problem-solving skill, good attention to details, and ability to clearly present results verbally in group meetings and in written progress reports.
  • Good interpersonal skills and willingness to ask questions about procedures and concepts.
  • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations.
What We Offer

Cambrex offers 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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