Analytical Scientist

Our client is a pioneering pharmaceutical company dedicated to transforming medicine through advanced drug delivery technologies. Our mission is to improve patient outcomes by developing innovative long-acting injectable therapies that provide sustained, controlled release of active pharmaceutical ingredients. Our collaborative and dynamic work environment fosters creativity, scientific excellence, and a commitment to making a real impact on global health.

**Key Responsibilities**:

- ** Method Development**:
Design and develop robust analytical methods for the characterisation and quantification of active pharmaceutical ingredients (APIs) and excipients in various formulations.
- ** Validation**:
Conduct method validation in accordance with regulatory guidelines (ICH, FDA, EMA) to ensure accuracy, precision, specificity, linearity, and robustness.
- ** Sample Analysis**:
Perform routine and non-routine sample analysis using advanced analytical techniques such as Particle Size Determination, DSC, HPLC, UPLC, GC, LC-MS, NMR, FTIR, and UV-Vis spectroscopy.
- ** Data Interpretation**:
Analyse and interpret complex data sets to provide insights into the physicochemical properties of drug formulations and their stability profiles.
- ** Documentation**:
Prepare detailed technical reports, method validation protocols, standard operating procedures (SOPs), and regulatory submission documents.
- ** Collaboration**:
Work closely with cross-functional teams, including formulation scientists, process engineers, and quality control, to support the development and optimisation of drug delivery systems.
- ** Troubleshooting**:
Identify and troubleshoot analytical challenges, providing innovative solutions to support project timelines and objectives.
- ** Compliance**:
Ensure all laboratory activities comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

**Qualifications**:

- ** Education**:

- ** Experience**:
Minimum of 3-5 years of hands-on experience in an analytical laboratory within the pharmaceutical or biotechnology industry.
- ** Technical Skills**:
Proficiency in chromatographic techniques (HPLC, UPLC, GC), Particle Size Determination or DSC or Rheology and spectroscopy methods (LC-MS, NMR, FTIR, UV-Vis). Experience with method development and validation is essential. Knowledge of QbD principals and KF/FT-IR would be a bonus.
- ** Regulatory Knowledge**:
Familiarity with regulatory requirements and ICH guidelines for analytical method validation and pharmaceutical development.
- ** Software**:
Experience with analytical software and tools such as Empower 3, Morphologi G3, ChemStation, or equivalent.
- ** Soft Skills**:
Strong analytical thinking, attention to detail, excellent written and verbal communication skills, and the ability to work effectively in a team-oriented environment.
- ** Problem-Solving**:
Demonstrated ability to troubleshoot complex analytical issues and develop practical solutions.