Epm Coordinator

6 months ago

Hyderabad Telangana, India Novartis Full time

**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 mínimal 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 mínimal 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

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