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Job Description - (Senior) Principal Scientist, Analytical Science
Job Title: (Senior) Principal Scientist - Analytical Science
Department: Pharmaceutical Development
Line Manager: Team Director
Location: South Manchester (occasional travel required for client meetings, CRO visits, and business development events across the UK and potentially abroad. Occasional overnight stays may be necessary).
Job Purpose:
The primary purpose of this role is to ensure excellence in the client's analytical science provision. You will be responsible for driving analytical science and regulatory components of client projects, providing mentoring to junior staff, and staying updated with the latest technological advances in analytical science, introducing those technologies when appropriate.
As a senior team member, you will support business growth by offering technical consultancy, scientific guidance, and supporting business development activities.
Typical Responsibilities:
The key responsibilities include:
* Providing analytical expertise to develop fit-for-purpose analytical methods for various drug products and troubleshooting development issues.
* Understanding and articulating global regulatory requirements for CMC submissions and designing product strategies accordingly.
* Combining scientific and pragmatic design thinking to deliver solutions for client compounds and products.
* Ensuring the client has the necessary analytical expertise and capabilities, including adopting new analytical technologies.
* Providing hands-on troubleshooting for complex analytical challenges.
* Managing pharmaceutical development projects as a project leader or manager.
* Managing and reviewing CRO activities on behalf of clients.
* Handling financial and contractual aspects of projects, including proposals and invoicing.
* Serving as a key contact for the client's global customer base.
* Authoring SOPs and best practice documents, and continuously improving analytical capabilities.
* Participating in and presenting at network events and conferences.
* Providing guidance, oversight, and coaching to staff.
* Performing other role-related activities as needed.
Requirements:
* PhD or equivalent with over 5 years' experience in pharmaceutical sciences and drug development, or a bachelor's degree with over 10 years' experience.
* Experience progressing analytical components through various development phases globally.
* Extensive interaction with global regulatory authorities.
* Good understanding of ICH quality guidelines and CMC regulatory requirements.
* Strong teamwork, communication, and influencing skills.
* Project leadership and independent working capabilities.
* Self-motivated, committed to self-development, and eager to learn.
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