You will be part of a multi-disciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non-commercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. This includes but is not limited to: supporting the manufacturing operations team, reviewing Standard Operating Procedures, executing batch records, and supporting commissioning and qualification of process equipment. Standard work will involve chemical synthesis of API, which includes these operational tasks: solid / liquid charges to vessels, atmospheric / vacuum distillations, liquid-liquid extractions, phase cut, crystallization, filtrations and drying.
ROLE RESPONSIBILITIES
- Execute Process Operating Instructions in a cGMP {part of GxP} environment.
- Responsible for equipment preparation, operational adjustment, process monitoring, sampling, and equipment cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures.
- Perform manual handling tasks, including lifting, carrying and moving objects weighing up to and exceeding 50 pounds on a routine basis throughout the work shift, using proper material鈥慼andling techniques and safety practices.
- Handle and segregate manufacturing waste in accordance with approved waste management, environmental, and safety requirements.
- Support equipment qualification/ commissioning activities.
- Adhere to cGMP and standard and local operating procedure requirements.
- Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.
- Identify opportunities for continuous improvements and enable implementation.
- Maintain cross-functional communication with tech transfer team: Compliance, Quality, Process Chemists, Analysists, and Process Supervisors.
- Perform troubleshooting of manufacturing support equipment and operations.
- Generate, assist, and execute documentation associated with cGMP API manufacture, such as working batch record and cleaning documentation and in-process control sampling.
- Support Standard Operating Procedure Periodic Reviews.
- Report any deviations or observations that might lead to adverse impact on product quality or process safety.
- Actively participate in shift exchange activities and communication channels.
- Complete training to take part in safety inspections within the facility.
- Manage own time, professional development, and be accountable for own results.
- Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.