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Senior Analytical Scientist
2 months ago
CK Group is seeking a Senior Analytical Scientist to join a leading global provider of specialty pharmaceutical ingredients.
This organization specializes in manufacturing and contract development and manufacturing organization (CDMO) services, with research and development (R&D) and Good Manufacturing Practice (GMP) facilities both in the UK and internationally.
In this pivotal role, you will be responsible for the analysis and characterization of innovative Active Pharmaceutical Ingredient (API) materials, supporting the development, scaling, and transfer of processes for both internal and client projects.
Key Responsibilities:
- Develop testing protocols suitable for various stages of API development, regulatory compliance, and market readiness.
- Provide scientific leadership and technical mentorship, including training and coaching for members of the analytical team.
- Ensure all experimental and analytical data is recorded in accordance with internal procedures that comply with GMP standards.
Qualifications:
Applicants should possess a degree or higher in Analytical Chemistry, Bioanalytical Science, Pharmaceutical Sciences, or Organic Chemistry, along with substantial industrial experience in an analytical laboratory setting focused on testing and data analysis within the pharmaceutical industry.
Candidates must demonstrate:
- Comprehensive knowledge of analytical techniques and methodologies (both instrumental and wet chemistry) applicable in the pharmaceutical field, along with practical experience in analyzing in-process and final API materials.
- Extensive hands-on experience in interpreting analytical data, a solid understanding of statistical methods, and familiarity with ICH, PIC/S, and FDA guidelines.
- Experience in the technology transfer of analytical methods, raw material testing, and cleaning verification is advantageous.
Successful candidates will exhibit strong analytical thinking and problem-solving abilities, with the capacity to manage multiple priorities and projects simultaneously.