- Plan and perform scientific experiments (or pilot plant processes) for the development and timely delivery of drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader.
- Support development projects aiming at the development of stable, bioequivalent, robust and cost-competitive dosage forms.
- Design and manage experiments/batches for simple/low complexity products under supervision, and provide related scientific documentation.
- Plan and execute experiments in agreement with quality risk management and GDevP/GMP standards.
- Assist in the preparation and review of the technological part of the dossier.
- Develop and optimize new dissolution method (Biorelevant and discriminatory dissolution method) mimicking the physiological system
- Independently perform and document solubility experiments, dissolution method activities and other characterization methods (DT, solubility, IDR, Viscosity etc).
- Testing of various developmental formulations in biorelevant and discriminatory dissolution methods
- Analysis of samples using various analytical techniques like HPLC/UPLC and spectrophotometric methods. Addressing the trouble shoots in chromatographic methods
- Write protocols, reports or lab procedures based on templates under expert s supervision.
- Document Risk assessment at pre-evaluation stage under expert s guidance.
- Knowledge of PBPK/IVIVC models.
- Assist modeling expert in developing various in-silico tools like Gastroplus/Phoenix WinNonlin etc.
- Work in close collaboration with multifunctional project team
What you ll bring to the role:
- Essential Requirements:Experience of 2-4 years in Analytical development from generic pharmaceutical industry.
- M Pharm (Pharmaceutical Analysis, Pharmaceutics); M Sc (Analytical Chemistry); B Pharm
- Attributes required of the job e.g. the ability to work independently; the ability to work in a team; shows initiative; able to work with all levels of staff.
- Strong written and oral communication skills.
