Associate Principal Scientist

ZipRecruiter; Macclesfield; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading company is seeking an experienced Associate Principal Scientist - Analytical to join their Technical Operations Science and Innovation team. This fully remote role involves managing analytical methods and regulatory processes for major commercial products, requiring strong technical expertise and leadership.

Responsibilities

• Serve as the responsible expert for a major commercial product in the Analytical area.
• Lead and support regulatory file authoring and review.
• Manage analytical method lifecycle activities for compliance.

Job description

Insight Global is seeking 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 methods, process engineering, statistics, modelling, devices, and testing.

Main Responsibilities

1. Serve as the responsible expert for a major commercial product or group of products in the Analytical area, such as Oral Solid Dosage formulations or parenteral formulations.
2. Lead and support regulatory file authoring, review, license renewals, and responses to questions, including coaching colleagues in these activities.
3. Provide strong technical expertise and leadership to resolve analytical method issues and complaints impacting supply.
4. Support the transfer of established analytical methods during product transfers within sites and to external manufacturing partners, including support for equivalency determination as applicable.
5. Manage analytical method lifecycle activities to ensure performance and compliance across sites.

This opportunity is fully remote in the UK, with occasional travel to the Macclesfield site for ad hoc training. It is a 12-month rolling contract.