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Senior Scientist III

2 months ago

Durham North Carolina, United States Cambrex Full time
About the Role

Cambrex is seeking a highly skilled and experienced Senior Scientist III to join our team in the Analytical Method Development and Validation department. As a key member of our team, you will be responsible for developing and validating analytical methods, ensuring compliance with regulatory requirements, and providing technical support to our clients.

Key Responsibilities
  • Develop and validate 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 maintain compliant records.
  • Participate in experimental design, including development of methods and testing requirements to demonstrate method suitability.
  • Maintain a strong understanding of compliance and provide input on site policy regarding compliance questions.
  • Ensure that client requests are within the boundaries of compliance and participate in compliance meetings.
  • Develop and execute validation protocols for analytical methods, 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.
  • Perform assigned tasks carefully, safely, and on schedule according to SOPs and supervisor instructions.
  • Set up various instrumentation for testing according to written test methods and with little to no supervision.
  • As needed, troubleshoot laboratory instrumentation and lead a sample project with assistance.
  • May participate in client-level meetings, with approval, and may lead and develop other team members.
  • May advise clients on site procedures and act as a team/project lead supporting scheduling of project tasks and deliverables.
  • Responsible for ensuring compliance with cGMP and other regulatory guidelines.
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.
  • 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.
  • General 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.
Education and Experience

B.S./B.A. Chemistry with 10+ years of experience in related industry or MS with 6+ years related experience or PhD with 2+ years related experience.