A day in the life of our Analytical Researcher
Lead/perform analytical method development and validation for drug substance/drug product (HPLC/UPLC, GC, KF, UV, FT-IR ).
Liaise and coordinate with the formulation team to deliver analytical support for early development/DOE/stability batches.
Participate in technical investigations and develop approaches to problem solving challenges which arise in early development
Write/reviewing technical documents for regulatory submissions and associated correspondence with regulatory agencies.
Work with third party contract lab facilities to develop and transfer analytical methods.
Ensure that all work is carried out in compliance with the required standards conforming to company, cGMP, GLP, SOP, regulatory, H&S and environmental requirements.
Work with cross-functional departments’ e.g Operations, QC, QA, Regulatory Affairs and Operations to address deficiencies, fillings of new regulatory applications etc.
Who we are looking for
Are you….
Educated to degree or Masters Level in Chemistry, (or related subject) with Strong industry experience preferably in an R&D environment.
Do you have…
Experience of development and validation of analytical methods for UPLC / HPLC / GC/Raw materials.
Ideally 1-2 years of experience in pharma environment
Knowledge of global regulatory and compliance requirements.
Writing/reviewing technical documents.
Good planning and organising skills & adaptable to changing priorities.