Ph.D. position available: Stability of Pharmaceutical Suspensions
Role highlights
Full Time
Permanent
Entry
On-site
This Ph.D. position focuses on the formulation characterization and stability of pharmaceutical suspensions, emphasizing the challenges associated with terminal sterilization methods such as moist heat autoclaving. Candidates should have a strong interdisciplinary interest spanning pharmacy, chemistry, and physics, particularly in the formulation and physical characterization of suspensions and solid-state materials. A relevant M.Sc. degree in pharmacy, chemistry, physics, or a closely related field is required. The project involves understanding degradation mechanisms in suspensions during sterilization, including aggregation, hydrolysis, oxidation, and Ostwald ripening, and seeks to improve physical stability using surfactants and cloud point boosters like polysorbates, poloxamers, PEG400, PEG3350, and lecithins. Familiarity with Quality by Design (QbD) principles, including risk assessment, process understanding, and robust design, is integral to the project. Preferred but not mandatory experience includes formulation design of suspensions, particle size characterization techniques, and advanced analytical methods such as X-ray powder diffraction (XRPD), solid-state nuclear magnetic resonance (NMR), and low energy Raman microscopy. Candidates must demonstrate independence and proficiency in English communication, both oral and written. The role offers an opportunity to contribute to enhancing the stability and regulatory compliance of parenteral suspensions, potentially impacting product quality, patient safety, and manufacturing efficiency.
About the role
Role Summary
- Ph.D. position in formulation characterization with focus on stability investigations of pharmaceutical suspensions
- Based at the Department of Physics, Chemistry, and Pharmacy in the pharmacy research group
Project Background
- Terminal sterilization is the preferred method for sterilizing pharmaceutical products in their final container
- Moist heat sterilization (autoclaving at 121°C) is widely used due to effectiveness, cost, and scalability
- Regulatory agencies (FDA, EMA) prefer terminal sterilization for higher Sterility Assurance Level (SAL) and reduced contamination risk
- Limitations exist for thermolabile drugs and colloidal formulations (e.g., injectable suspensions) that degrade at high temperatures
- Terminal sterilization of suspensions can cause aggregation, hydrolysis, oxidation, Ostwald ripening, and other degradation
- Most parenteral suspensions are made via aseptic processing, which is complex, costly, and riskier for contamination
- Surfactants (e.g., polysorbates, poloxamers) are used to stabilize suspensions but may phase invert at autoclave temperatures
- Cloud point boosters (e.g., PEG400, PEG3350, lecithins) can raise the cloud point, allowing for higher temperature sterilization
- Project follows Quality by Design (QbD) principles: risk assessment, process understanding, robust design
- Aim: Improve physical stability of aqueous suspensions and extend terminal sterilization applicability for parenteral suspensions
- Potential impact: Enhanced product quality, regulatory compliance, patient safety, and economic benefits
Requirements
- Strong interest in working at the intersection of pharmacy, chemistry, and physics, focusing on formulation and characterization of suspensions and solid materials
- M.Sc. in pharmacy, chemistry, physics, or closely related area
- Advantageous experience (not required):
- Formulation design of suspensions
- Particle size characterization
- XRPD
- Solid state NMR
- Low energy Raman microscopy
- Independence and fluency in English (oral and written)
How to Apply
- Application deadline: 26 December at 23:59 local Danish time
- See the full call and application instructions on sdu.dk
- Mention in your application that you found the job at Jobindex
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