Ref No: AM17412
County Cork, Republic of Ireland
Team Leader Biotech TS/MS (Technical Services/Manufacturing Science) - County Cork.
As a member of the Biotech/Large Molecule (LM) management team, the TS/MS Team Leader is a key leader in the cross-functional support of the Large Molecule business and operations. The TS/MS Team Leader 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 TS/MS Team Leader provides leadership and direction to the TS/MS representatives 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.
Active member of the cross-functional, manufacturing support LM management team, understanding the business and their role to ensure the LM business objectives are met.
Supervision and coaching of LM TS/MS representatives including completing performance reviews and development planning, to ensure continued growth of technical depth and capability with the team.
Oversight of TS/MS staffing and resource allocation to support operations, NPI and Process Validation activities, and productivity/continuous improvement initiatives.
Provide technical oversight as needed for process related deviations and investigations.
Review and approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, change controls, APRs and validation documentation.
Active participation in ensuring a continued state of cGMP compliance and readiness for Pre-Approval Inspections (PAIs) and Routine GMP Inspections by various regulatory agencies.
Promote continued alignment in technical operations across LM facilities, and across the wider network. Support further improvements in alignment where opportunities exist.
Interested applicants should have:
Proven technical capability within a Large Molecule Manufacturing environment.
Previous GMP Manufacturing experience and New Product Introduction knowledge.
Previous leadership experience through existing or previous roles.
Minimum Master's degree in a Biological Science or Engineering Discipline
At least 8-10 years' industrial experience in a cGMP environment