Principal scientist

2 weeks ago

Hyderabad, India Curateq Biologics Full time

Role & responsibilities

1.Stability Studies Management: Planning and management stability studies, Comparative Stability and Forced Degradation (FDS) Studies, Reference product age related studies of all the projects. Compilation of stability data, interpretation, and data trending. To review the data, related DRS and LNBs etc.

  1. Drafting / review / approval of operational SOP, LP, SLP and Stability Protocols, Summary Sheets, Reports as required.

  2. Planning and management of the IRS: Planning and management for establishment of internal reference standards. Management of IRS stability studies, issuance, compilation and trending the retrospective data of the established internal standards.

  3. Excipient Analysis: To plan and manage experiments for the excipient analysis. Management and guidance for method development, qualification and method transfer for Excipients methods. Drafting/review of system SOP, development report, qualification plan, qualification protocols and report and any other protocols/reports/plans as required.

  4. To implement QbD and DOE concepts for better experimental planning.

  5. To participate in the relevant cross functional meetings to assimilate the pace of the projects and to percolate it down to the team.

  6. To host weekly/need basis meetings within and across the teams for better knowledge sharing.

  7. To ensure the proper and optimum use of resources by maintaining the proper work balance across the team members.

  8. Lab compliance and other activities: Responsible for overall GLP lab compliance in stability, excipient and IRS team. Calibration, validation, and PM activities of instruments and equipments

  9. To train, coach and mentor the juniors in the team on technical and personal development aspects. To identify the right forums and trainings in the benefit of the team for further growth enhancement.

  10. To play instrumental role in lab set up and upkeep, up gradation of any equipment/technology (whichever applicable) catering to the latest advancements in the industry.

  11. To monitor smooth functioning of ERP related activities based on the requirements by coordinating with team members.

  12. Ensure compliance of team members to legal, ethical, safety, QA and GLP requirements.

  13. Building upon the strengths of scientific understanding to play the role of second level.

SMEs for relevant methods and techniques.

  1. To take up any other activity assigned based on the need and team's requirements.

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