Job Description
The Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites.
The SSO Operations Specialist will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) requirements to meet SSO objectives and customer requirements. The position is responsible for implementing actions to meet S&E and GMP requirements. This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success and performance of the building, and ultimately strong support for the overall SM PR&D pipeline.
Responsibilities:
- Under the scientific direction of a facility lead, the Operations Specialist will participate in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents, solvents, and active pharmaceutical ingredients during “wet chemistry” operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) Also, dry powder processing (e.g., dry milling).
- Ensure processes are run within the capability constraints of the facility.
- Ensure facility readiness with respect to cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory.
- Provide input for incident root cause analysis, reporting, and action items.
- Facilitate and drive building improvement projects and corrective/preventative action closures.
- Provide input on process setups.
- Provide regular feedback to peers to promote a continuous improvement mindset.
- Collaborate with all building staff to share and align on best practices.
- Actively investigate problem statements and safety observation reports (SORs) to promote fast and efficient closure.
- As needed, safely perform High Risk Work involving hazardous energy control.
- Identify and follow through on opportunities to improve building flexibility, efficiency, compliance, and safety.
- Author lessons learnt and summary reports to capture knowledge gained.
- Mentor and help train rotational and new employees.
- This position’s primary focus is executing batch production work. Additional responsibilities include coordination, planning, documentation, and other facility improvement activities.
