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.
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