Job Description
The role of a Senior Analytical Scientist is to provide analytical leadership for all aspects of advanced analytical technologies and methods within the Analytical sciences/Quality control characterisation area.
Key Responsibilities:
* Provide analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects.
* Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.
* Execute and/or oversee testing protocols in accordance with local procedure and regulatory requirements.
* Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
* Act as SME for one or more technologies and/or business systems within QC.
* Ensure all raw materials, in-process samples, intermediates or final products are appropriately analyzed and authorised.
* Lead analytical investigations, using Root Cause Analysis techniques where appropriate, in the event of non-conformance to acceptable quality and/or safety standards.
* Work with onsite technical teams to improve the state of validation and drive analytical variability reduction.
* Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients and Laboratory Periodic Review Reports (PRRs).
* Participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
Requirements
* BSc/MSc Analytical Sciences (Chemistry or Biochemistry) with at least 5 years pharmaceutical analytical chemistry experience or PhD/Post Doctorate Level in Analytical Science (Chemistry or Biochemistry) with 3-5 years of recent bench experience in advanced analytics environment.
* Deep technical expertise in analytical chemistry techniques, in particular in separation sciences, biophysical and mass spectrometry techniques.
* Proficiency in the use of multiple instrument platforms (e.g. Thermo, Agilent, etc.).
* High learning agility and flexibility to achieve the required outcomes.
* Working knowledge in one or more of the following chemical, peptide or protein synthesis.
* Development and implementation of multi-attribute methods (PAT or offline).