Description:
As a member of the Small Molecule (SM) management team, the TS/MS Associate Director is a key leader in the cross functional support of the Small Molecule business and operations. The Associate Director TS/MS (SM) reports to the Sr. Director -TS/MS (SM) and is responsible for TS/MS business processes including support of new product introduction and technology transfer, process validation, process monitoring, productivity and continuous improvement projects. Additionally, the Associate Director TS/MS provides leadership and direction to the TS/MS Scientists in their area, to ensure that they meet their short to medium term goals including day to day technical operations support, NPI delivery as well as continuous improvement projects within the area..
Key Responsibilities
- Active member of the cross-functional, manufacturing support SM management team, understanding the business and their role to ensure the SM business objectives are met.
- Supervision and coaching small molecule TS/MS staff including completing performance reviews and development planning, to ensure retention of technical depth and capability
- Oversight of TS/MS staffing and resource allocation to support operations, NPI and Process Validation activities, and productivity/continuous improvement initiatives.
- Able to support the graduate and postdoctoral student programme and industry representation e.g. SSPC and SFI
- Assist as needed in Major Deviations and Severe /Catastrophic Event investigations
- Identify, prioritise, delegate and support the implementation of continuous improvement initiatives, lean initiatives and cost reduction measures to align with the Kinsale business mission.
- Ensures that adequate resources are in place to support operations, commercialization and technical agenda activities
- Technically challenge projects to ensure they are scientifically robust prior to implementation.
- Review and approval of specific quality documents consistent with procedure requirements
- Maintaining the Small Molecule area in a state of cGMP compliance and readiness for Pre-Approval Inspections (PAIs) and Routine GMP Inspections by various regulatory agencies.