Senior Principal Scientist

2 days ago


Macclesfield, Cheshire East, United Kingdom SRG Full time

Job Title: Senior Principal Scientist - Analytical Science Expert

Department: Pharmaceutical Development and Manufacturing

Line Manager: Senior Director of Analytical Science

Salary: Negotiable and Competitive

Location: Remote or On-Site at Client Facilities

Job Purpose: The primary purpose of this role is to ensure excellence in the company's analytical science provision. You have responsibility for driving the analytical science and associated regulatory components of client projects and providing mentoring and coaching to more junior analytical staff. You keep up to date with the latest technical advances in analytical science and, where appropriate, introduce those technologies into the business.

Key Responsibilities:

  • Bring analytical expertise to guide the development of fit for purpose analytical methods for a range of simple and complex drug products, and trouble shoot any method development issues.
  • Understand and articulate global regulatory requirements for a CMC submission and design the product strategy accordingly.
  • Ensure the company has the right analytical expertise and capability to support existing and new client programmes, including the introduction of new analytical technologies as appropriate.
  • Provide hands on laboratory trouble shooting for complex analytical challenges when required.
  • Act as pharmaceutical development project leader / manager for some client projects.
  • Manage and review CRO activities on behalf of clients.
  • Management of the financial and contractual aspects of projects with clients, such as costing proposals and invoicing.
  • Act as a key point of contact for the company's global client base.
  • Participate and present at network events, conferences.

Requirements:

  • Educated to PhD and greater than 5 years' experience in the pharmaceutical sciences and drug development or bachelor's degree and greater than 10 years' experience in the pharmaceutical sciences and drug development.
  • Experience of progressing the analytical components of various drug projects through different development phases (discovery to launch) across global markets.
  • Wide ranging experience of interactions with global regulatory authorities.
  • Good understanding of ICH quality guidelines and global CMC regulatory requirements.

About SRG:

SRG is a leading recruitment company specializing in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals, and medical devices sectors. Our team of experts has a deep understanding of the industry and can provide tailored recruitment solutions to meet the needs of our clients. We are committed to providing outstanding temporary, contract, and permanent career opportunities for our candidates and a comprehensive range of expert strategic recruitment services for our clients.



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