Our client, a creator of a new class of RNAi medicines has an immediate need for a Lead Manufacturing Technician (LMT). The LMT oversees manufacturing department and all activities within the manufacturing area. This includes but is not limited to production, scheduling, maintenance, Quality and work functions in the area of weigh/dispense, solution preparation, formulation and UF/DF processing.
The LMT performs routine and non-routine manufacturing operations at the manufacturing facility and operates production equipment according to SOPs for the production of clinical and/or commercial products. The role requires technical capabilities to interact with support groups (Facilities, Process Development, Engineering and Validation etc.) to ensure accurate and well managed transfer of process changes.
The candidate schedules, organizes and oversees floor operations to ensure safety, aseptic operations and compliance are maintained at all times. The LMT routinely works with cross-functional groups to provide support and improve site operations.
Carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and Batch Records. Responsibilities include:
- Troubleshoot and resolve process related issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses and corporate policies.
- Ensure all operations and documentation conform to cGMP standards and that all SOPs and batch records are maintained to reflect current manufacturing methods.
- Use technical writing skills to own and complete deviations, CAPAs and change controls as required.
- Identify and implement continuous improvement projects utilizing independent project management skills.
- Create work orders as needed, and coordinate work to prevent maintenance and calibration events from impacting schedule.
- Perform Batch Record, Logbook requests and review manufacturing documentation to ensure compliance.
- Propose and review documentation revisions
- Carry out work in a safe manner, notifying management of safety issues and risks.
- Support execution of equipment and process qualification and validation and review associated protocols
- Provide technical training to junior employees, meet and maintain training material requirements.