Senior Analytical Scientist

7 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 developing and implementing analytical methods for the release and stability testing of drug substances and drug products.

Key Responsibilities
  • Develop and evaluate analytical methods for in-process control, release testing, and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
  • Independently develop and evaluate methodologies, design and implement experiments, and apply prior knowledge to accurately interpret structural data.
  • Collaborate with cross-functional teams to ensure compliance with cGMP and other regulatory guidelines.
  • Develop and maintain compliant records with little or no supervision.
  • Train and mentor other employees on analytical techniques and methodologies.
  • Participate in experimental design, including development of methods and testing requirements to demonstrate method suitability.
  • Perform and review data analysis and draft reports for analytical method development and validation.
  • Identify and troubleshoot analytical problems with instrumentation, general chemistry, test methodology, and samples submitted.
  • Lead a sample project with assistance and participate in client-level meetings with approval.
  • Develop and maintain laboratory equipment and supplies as directed.
  • Participate in group and project meetings as required.
Requirements
  • B.S./B.A. Chemistry with 12+ years of experience in related industry or MS with 8+ years related experience or PhD with 4+ years related 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.
  • Can articulate and evaluate project concepts and strategy.
  • Operates with substantial latitude for independent actions and decisions relating to technical problems and procedures.
  • Recognized as a technical resource in a related area.
  • Expert in related technologies.
  • Demonstrates continued development in a relevant area of CMC.
  • Working knowledge of advanced laboratory techniques.
  • Working exposure to cross-functional techniques including organic chemistry.
  • Subject matter expert in one or more instruments (i.e., GC, LC, dissolution, TGA/DSC).
  • Able to comply with SOPs and have understanding of regulatory compliance.
  • Working knowledge of scientific concepts, principles, and procedures.
  • Actively and positively engages with team and supports process improvements.
  • Ability to read and execute compendial methodologies.
  • Strong understanding of current FDA and cGMP regulations.
  • Strong knowledge of chemistry and scientific calculations.
  • Hands-on experience in analytical techniques such as HPLC, GC, etc.
  • Strong computer skills.
  • Ability to operate laboratory equipment and computers.
  • Ability to take direction from experienced scientists and contribute in a team.
  • Environment
  • Ability to effectively train and mentor others.
  • Good problem-solving skill.
  • Good attention to details.
  • Can repeat and follow detailed scientific procedures.
  • Able to clearly present results verbally in group meetings and in written progress reports.
  • Routinely and effectively presenting findings to clients.
  • Good interpersonal skills and is willing to ask questions about procedures and concepts.
  • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations.
  • Good written and verbal communication skills.
  • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.
  • Aptitude and willingness to gain more skills & knowledge.
  • Good attention to detail and good problem-solving skills.
What We Offer

Cambrex offers a competitive salary and benefits package, as well as 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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