RE: Senior Manager, Stability, Analytical Sciences - Basel
EPM Scientific has partnered with a rapidly growing biotechnology company in need of a Analytical Development Consultant in Basel.
The idea will be to start on a 9 month contract and possibility for a permanent role after or extension is possible.
- Oversees, monitors, controls and ensures timely execution of CMOs/CROs deliverables
- Collaborates with project teams to define stability commitments for study design, testing requirements and stability specifications, as appropriate.
- Creates and/or reviews stability study protocols.
- Prepares accurate stability summary reports for CMC regulatory submissions, annual reports, and periodic updates to RA or QA
- Supports stability-related investigations.
- Supports completion of Quality audit responses via any related updates to reported stability data, summaries, SOPs or other corrective action required.
- 10+ years analytical sciences experience in the bio-pharmaceutical industry
- Good understanding of Tech-Ops business processes, including strategic and tactical planning
- Strong technical knowledge of pharmaceutical analysis applied to product release and stability testing
- Proficient in cGMPs
- Solid knowledge of FDA and EMA technical guidelines related to analytical sciences
- Analytical development expertise
- Fluent English
Please feel free to send your updated CV