06 Sep
|
USV
|
Govandi East
Role Objective:
To execute hands-on laboratory experiments for the formulation development of sterile liquid injectables, drug-device combination products, and lyophilized formulations. This role focuses on day-to-day experimental execution, cycle optimization, device compatibility evaluation, and operational troubleshooting under the guidance of senior team members to ensure smooth project progression.
KEY RESPONSIBILITIES
- Formulation Execution: Conduct routine laboratory experiments to develop reliable, robust sterile liquid injectable dosage forms and troubleshoot technical issues during development.
- Drug-Device Testing: Perform compatibility, functional testing, and quality evaluations for drug-device combination products in alignment with regulatory expectations.
- Lyophilization Support: Execute freeze-drying runs for peptides, proteins, and small molecules, aiding in cycle development, optimization, and characterization.
- Laboratory Operations: Maintain analytical and processing equipment, document experimental protocols, keep meticulous laboratory notebooks,
and draft standard operating procedures (SOPs).
- Scale-Up Assistance: Assist senior scientists in technology transfer activities, batch manufacturing records (BMR) preparation, and pilot batch execution.
- Compliance: Ensure strict adherence to cGMP guidelines, safety standards, and internal quality systems in all daily laboratory activities.
STAKEHOLDER INTERACTION
Type of Interaction: Internal
- Interaction with: Senior Scientists, Analytical R&D;, Quality Assurance, and Packaging Development.
- Nature of Interaction: Daily routine work alignment, reporting experimental results, sample handover for analytical testing, and technical data discussion.
Type of Interaction: External
- Interaction with: Raw material suppliers and analytical/equipment vendors.
- Nature of Interaction: Procurement of lab samples/reagents, routine equipment calibration support, and gathering technical product specificatio
📌 Executive- Formulation (Govandi East)
🏢 USV
📍 Govandi East