Principal Scientist I

5 days ago

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

We are seeking a highly skilled Principal Scientist I to join our team at Cambrex. This role will be responsible for executing analytical methods and providing general analytical support, including release and stability testing of drug substances and drug products.

Key Responsibilities
  • Develop and evaluate methodologies, design and implement experiments, and apply prior knowledge to accurately interpret structural data.
  • Execute analytical methods for in-process control, release testing, and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
  • Independently plan, perform, and analyze experimental results in a timely manner, and draft and execute validation protocols for analytical methods.
  • Perform and review data analysis, draft reports for analytical method development and validation, and identify and troubleshoot analytical problems with instrumentation, general chemistry, test methodology, and samples submitted.
  • Lead a sample project with assistance, participate in client-level meetings with approval, and routinely lead and develop other team members.
  • Act as a technical resource in a related area, recognized as an expert in related technologies, and demonstrate continued development in a relevant area of CMC.
  • Participate in cGMP activities, provide input on SOPs and client questions, and maintain laboratory equipment and supplies as directed.
  • Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems, and participate in group and project meetings as required.
Requirements
  • 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, able to articulate and evaluate project concepts and strategy.
  • Recognized as a technical resource in a related area, expert in related technologies, and demonstrates continued development in a relevant area of CMC.
  • Working knowledge of advanced laboratory techniques, working exposure to cross-functional techniques including organic chemistry, and subject matter expert in one or more instruments.
  • Able to comply with SOPs and have understanding of regulatory compliance, working knowledge of scientific concepts, principles, and procedures, and 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, and hands-on experience in analytical techniques such as HPLC, GC, etc.
  • Strong computer skills, ability to operate laboratory equipment and computers, and 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, and 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, and aptitude and willingness to gain more skills & knowledge.
  • Good attention to detail and good problem-solving skills.
Qualifications

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.

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