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Asso Scientist IVIVC (Biopharmaceutics)

Asso Scientist IVIVC (Biopharmaceutics)

ConfidentialWarangal, Hyderabad / Secunderabad, Telangana, Nizamabad
30+ days ago
Job description
  • 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.
    • Skills Required

      Analytical Development, Risk Assessment

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    Scientist • Warangal, Hyderabad / Secunderabad, Telangana, Nizamabad

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