Lead production teams to produce high quality solid dosage form clinical supplies utilizing state-of-the-art technologies. This requires interaction with formulation colleagues to develop reliable and efficient manufacturing processes. These processes are then translated into executable manufacturing instructions when followed appropriately result in the efficient production of GMP compliant clinical supplies.
- Operations: Leads manufacturing activities, including the preparation and close out of batch records; Ensures the batch record documentation is executed with minimal errors; Starts and completes manufacturing activities on time, according to the established schedule. Leads discussions with QA on quality related topics associated with manufacturing and documentation. Manages X-step content to ensure PI sheets are accurate.
- Supervision: May supervise the pilot plant technicians including daily scheduling of activities, managing personnel development, holding technicians accountable against performance expectations, and writing and delivering performance reviews. May provide similar supervision to Clinical Manufacturing Lead I and/or II.
- Formulation Development: Collaborates with formulators on formulation development and research activities occurring in the pilot plant. Provides key pilot plant capabilities insight on these activities.
- Technical Support: Possess detailed knowledge of pilot plant equipment and processing capabilities. Provide technical guidance to manufacturing personnel. Provides leadership with trouble-shooting and identifies solutions to issues that arise during manufacturing; Provides strategic product development and technology improvement activities; actively participates in functional area improvement initiatives.
- Compliance: Understands and follows cGMP requirements, established policies; Writes and follows procedures and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
- Project Coordination: Works with the CMC team and other supporting areas to assure project commitments are met, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions.
- Communication: Records, tabulates and reports results within the group or team using the necessary tools (Reports, memos, presentations, spreadsheets, notebooks, etc.); Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicates concerns and participate in discussions.
- Leadership: Direct activities of manufacturing technicians in a matrix environment.