Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- Coordinating reference material activities (laboratory and large-scale production, labelling, analysis, storage and distribution) across multiple development projects.
- Supporting projects from early development through Phase III and until commercial manufacture.
- Preparing, reviewing and maintaining scientific documentation (protocols, reports and regulatory documentation).
- Working closely with Analytical Project Managers and scientists across CMC.
- Ensuring GMP compliance and maintaining high documentation standards.
- Supporting regulatory documentation throughout the development lifecycle.
- Managing priorities across approximately 15–20 concurrent projects.
- Building strong relationships with stakeholders across Analytical Development, API, Formulation, Manufacturing and Quality.
- Contributing to continuous improvements within established processes while learning the specialist Reference Materials function.
Qualifications
Highest qualification: University
- A master’s degree (minimum) in Pharmacy, Chemistry, Biochemistry, Biotechnology or another relevant scientific discipline. A PhD is also welcomed.
- Experience working within the pharmaceutical industry.
- Good understanding of GMP.
- Experience preparing scientific or regulated documentation.
- Strong organisational and coordination skills.
- Excellent written and spoken English.