12-Month Fixed-Term Opportunity
This role is offered on a hybrid working model, combining home-based work with time on site in Stevenage.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Summarised Purpose:
The Reference Standard Scientist will lead the management and oversight of Reference Standards (RS) for small molecule drug substances and products. This role ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal standards, supporting the quality and integrity of analytical data for clinical and commercial use.
Essential Functions:
- Co-ordinate and support the testing and documentation of all aspect of characterisation, qualification and stability, including retest and shelf-life extensions, of Reference Materials (Primary, Working, and Development Standards) in accordance with client processes and procedures, ensuring compliance with GMP requirements where required.
- Manage the inventory and coordinate distribution of reference materials
- Establish and maintain partnerships with Global Supply Chain, Analytical Project Scientists, Quality and Third parties to ensure high quality, efficient service delivery
- Co-ordinate and manage the transfer of information for R&D reference materials to the commercial reference materials group.
- Actively prepare and support internal quality and external regulatory inspections.
- Proactively contribute to the resolution of technical and operational problems for reference materials and certificate of analysis generation.
- Draft Certificates of Analysis in accordance with the relevant regulations, corporate policies and standards to ensure patient safety, product quality and data integrity.
- Adopt data and digital tools to drive continuous improvement and deliver simplified, efficient business processes.
Knowledge, Skills and Abilities:
- Bachelor of Science in Chemistry, Biology, or other related scientific discipline or experience in a directly related discipline.
- Experience in a project team or directly related discipline.
- Experience in LIMS system for data recording and reporting.
- Knowledge and/or experience with digital tools for inventory management or data reporting is beneficial.
- Ability to work with multiple tasks simultaneously to meet client needs is essential.
- Ability to work in a collaborative work environment with a team.
- Knowledge of general chemistry and separation science.
- Proficiency on technical operating systems.
- Proven ability in technical writing skills.
- Time management and project management skills.
- Good written and oral communication skills.
- Ability to travel to the Ware site occasionally
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
