Job Description
Insight Global are looking for an experienced Associate Principal Scientist - Analytical to play a key role in our client’s Technical Operations Science and Innovation (TOSI) organization. TOSI provides technical support and expertise related to products, manufacturing, analytical, process engineering, statistics, modelling, devices, and testing.
The areas in which they deploy their technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk, and manufacturability. This role works closely with many technical functions across Global Operations providing the ability to drive science and build capability within the organization and the ways of working.
Please note, this opportunity is based fully remote in the UK, with occasional travel required to their site in Macclesfield for training on an adhoc basis. This is a 12-month rolling contract opportunity.
Please see the main responsibilities for this position below:
• Responsible expert for a major commercial product or group of products related to the Analytical subject matter area e.g. Oral Solid Dosage formulations, parenteral formulations,
• Leadership and support for regulatory file authoring, review, license renewals and response to questions, including coaching colleagues with these activities.
• Provision of strong technical expertise & leadership to aid in the resolution of analytical method issues & complaints impacting supply.
• Responsible for the technical support during the transfer of established product analytical methods within sites and to external manufacturing partners including support for equivalency determination as applicable.
• Responsible for analytical method lifecycle activities to ensure performance and compliance across sites.