Associate Principal Scientist

JR United Kingdom; Macclesfield; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading company is seeking an experienced Associate Principal Scientist to join their Technical Operations Science and Innovation team. This fully remote role involves providing technical support for drug product improvement and collaborating with various functions to drive scientific advancements. The ideal candidate will have strong analytical expertise and leadership skills, particularly in regulatory processes and analytical methods.

Qualifications

• Experience with Oral Solid Dosage and parenteral formulations.
• Strong background in regulatory file authoring and compliance.

Responsibilities

• Serve as the expert for major commercial products in analytical areas.
• Lead regulatory file authoring and support method transfers.
• Manage analytical method lifecycle activities.

Skills

Analytical Expertise

Leadership

Technical Support

Education

PhD in a relevant field

Job description

Social network you want to login/join with:

Associate Principal Scientist, Macclesfield

Client:

Insight Global

Location:

Macclesfield, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

Job Views:

5

Posted:

12.05.2025

Expiry Date:

26.06.2025

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.

Their technical expertise supports drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk, and manufacturability. This role collaborates closely with various technical functions across Global Operations to drive scientific advancements and build organizational capability.

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

Main responsibilities include:

1. Serving as the responsible expert for a major commercial product or group of products related to analytical subject areas, e.g., Oral Solid Dosage formulations, parenteral formulations.
2. Leading and supporting regulatory file authoring, review, license renewals, and responding to questions, including coaching colleagues in these activities.
3. Providing strong technical expertise and leadership to resolve analytical method issues and complaints impacting supply.
4. Supporting the transfer of established analytical methods within sites and to external manufacturing partners, including support for equivalency determination.
5. Managing analytical method lifecycle activities to ensure performance and compliance across sites.