Senior Analytical Chemist

CK Group are recruiting for a Senior Analytical Chemist to join a global manufacturer of speciality pharmaceutical ingredients who are based in Reading, on a permanent basis.

Company:

The company are a specialist Manufacturer and CDMO provider with R&D and GMP manufacturing facilities in the UK and globally.

Location:

The role is based in Reading and is site based.

Role:

Take a leading role in the analysis and characterisation of novel API materials, aiding the development, scale up and transfer of processes for both our in-house and client projects. Perform efficient and effective method development/optimisation tasks, method transfers, validations, forced degradation and stability studies, including the preparation of protocols and reports to the required standard, as required. Develop testing requirements appropriate for different phases of API development, regulatory approval, and commercialisation. Work collaboratively with other areas of the business to develop and establish methods specifications, new techniques, recommend alternative approaches and solutions to analytical challenges. Provide scientific leadership & technical guidance, training and coaching to other members of the Analytical team. Ensure that all experimental and analytical data are documented following internal procedures compliant with GMP.

Your Background:

Educated to degree level or above in Analytical, Bioanalytical, Pharmaceutical Sciences or Organic Chemistry with significant industrial experience in an analytical laboratory performing testing and data analysis/interpretation within the pharmaceutical sector. In-depth theoretical knowledge and practical application of method development, validation and troubleshooting of HPLC, UPLC and good practical knowledge of GC, GC-headspace, IC, KF, UV and polarimetry. In-depth knowledge of analytical techniques and methodologies (instrumental and wet chemistry) used in the pharmaceutical sector and demonstration of their practical application in the analysis of in process and final API materials. Extensive practical experience of analytical data interpretation, good understanding of statistical methods and knowledge of the ICH, PIC/S & FDA guidelines is required. Experienced in Technology Transfer of analytical methods,raw materials testing, and cleaning verification is an advantage. Proven analytical thinking and problem-solving skills and the ability to balance multiple priorities and projects at the same time.