REQ-10012447
Juni 29, 2024
Indien

Summary

-Plan and perform scientific experiments (or pilot plant processes) for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab instruments/infrastructure. -SANDOZ: 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. Contribute to maintenance of lab instruments/infrastructure. -Support development projects aiming the development of stable, bioequivalent, robust and cost competitive dosage forms -Design and manage experiments/batches for simple/low complexity products under supervision, provide related scientific documentation -Plan and execute experiments in agreement with quality risk management and GDevP /GMP -Assists in the preparation of and reviews of the technological part of dossier

About the Role

Major accountabilities:

  • Meet quality, quantity and timelines in all assigned projects.
  • Plan, organize, perform and document scientific experiments /plant activities in collaboration with experienced team members if necessary.
  • Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary.
  • Plan and perform scientific experiment /plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team members under guidance.
  • ( eg.
  • contribute to interpretation and report results ) -Provide efficient and robust processes for the manufacture and /or specialized facilities with adequate guidance.
  • Provide efficient and robust processes for the manufacture and /or specialized facilities with adequate guidance.
  • Provide raw data documentation, evaluation and results interpretation.
  • Propose and provide input for the design of next experiments.
  • Optimize existing methods (lab or plant) and develop more efficient ones.
  • Optimize existing methods (lab or plant) and develop more efficient ones.
  • Generate lab procedures, reports and /or instructions and/or SOP’s -Actively transfer procedures /instructions to pilot plant or production, including troubleshooting, process steering controls etc. -Actively transfer procedures /instructions to pilot plant or production, including troubleshooting, process steering controls etc. -Uses professional concepts and company's policies and procedures to solve a variety of problems.
  • Receives detailed instructions on all work -Receives detailed instructions on all work -SANDOZ : -Plan, organize, perform and document scientific experiments/plant activities under supervision.
  • Provide raw data documentation, evaluation and results interpretation.
  • Propose and provide input for the design of next experiments.
  • Adherence to Sandoz standards, in particular quality (cGxP, data control), ethical, health, safety, environment (HSE), and information security (ISEC).
  • Review and verify raw data generated by others -Perform the transfer of procedures to other departments or qualification/validation of procedures under supervision-Optimize or troubleshoot existing methods/processes and develop new methods /processes based on published methods/processes under supervision -Address and solve problems of high complexity under minimal supervision.
  • Provide solutions on deviations and unexpected results from experiments.
  • Participate in function-specific teams and fulfil assigned project tasks and responsibilities under supervision.
  • Actively maintain laboratory inventory (e.g. chemicals, raw materials, consumables) within own area of responsibility -Collaborate within and with other groups and sites.
  • Schedule and perform maintenance and qualification of instruments /equipment including responsibility for selected equipment.
  • Contact supervisor / vendor in case of unresolvable problems.
  • Generate lab procedure

Key performance indicators:

  • Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to quality, quantity and timelines for all assigned tasks.
  • Ensures reproducibility of experiments and results.
  • Refer to annual individual and team objective settingSANDOZ: Associate Scientist: • Successful execution of assigned tasks and work packages• Successful interactions within department• Compliance with Novartis / Sandoz rules and guidelines• Feedback from relevant stakeholders• First -time -right -Technician: -Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to quality, quantity and timelines for all assigned tasks.
  • Ensures reproducibility of experiments and results.
  • Refer to annual individual and team objective setting

Minimum Requirements:
Work Experience:

  • Collaborating across boundaries.
  • Operations Management and Execution.

Skills:

  • Environment.
  • Health And Safety (Ehs).
  • Laboratory Equipment.
  • Manufacturing Process.
  • Materials Science.
  • Process Simulation.
  • Sop (Standard Operating Procedure).

Languages :

  • English.

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Innovative Medicines
Indien
Hyderabad (Office)
Research & Development
Full time
Regular
No
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REQ-10012447

Assoc. Expert - Technical Development

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