CK Group are recruiting for a Senior AnalyticalChemist to join a global manufacturer of speciality pharmaceuticalingredients who are based in Reading, on a permanentbasis.
Company:
The company are a specialist Manufacturer and CDMO provider withR&D and GMP manufacturing facilities in the UK andglobally.
Location:
The role is based in Reading and is site based.
Role:
* Takea leading role in the analysis and characterisation of novel APImaterials, aiding the development, scale up and transfer ofprocesses for both our in-house and clientprojects.
* Perform efficient and effectivemethod development/optimisation tasks, method transfers,validations, forced degradation and stability studies, includingthe preparation of protocols and reports to the required standard,as required.
* Develop testing requirementsappropriate for different phases of API development, regulatoryapproval, and commercialisation.
* Workcollaboratively with other areas of the business to develop andestablish methods specifications, new techniques, recommendalternative approaches and solutions to analyticalchallenges.
* Provide scientific leadership &technical guidance, training and coaching to other members of theAnalytical team.
* Ensure that all experimentaland analytical data are documented following internal procedurescompliant withGMP.
YourBackground:
* Educatedto degree level or above in Analytical, Bioanalytical,Pharmaceutical Sciences or Organic Chemistry with significantindustrial experience in an analytical laboratory performingtesting and data analysis/interpretation within the pharmaceuticalsector.
* In-depth theoretical knowledge andpractical application of method development, validation andtroubleshooting of HPLC, UPLC and good practical knowledge of GC,GC-headspace, IC, KF, UV andpolarimetry.
* In-depth knowledge of analyticaltechniques and methodologies (instrumental and wet chemistry) usedin the pharmaceutical sector and demonstration of their practicalapplication in the analysis of in process and final APImaterials.
* Extensive practical experience ofanalytical data interpretation, good understanding of statisticalmethods and knowledge of the ICH, PIC/S & FDA guidelines isrequired.
* Experienced in Technology Transfer ofanalytical methods,raw materials testing, and cleaning verificationis an advantage.
* Proven analytical thinking andproblem-solving skills and the ability to balance multiplepriorities and projects at the same time.
Apply:
It isessential that applicants hold entitlement to work in the UK.Please quote job reference 105939 in allcorrespondence.