Job Description
The Technical Services Team Leader will be a member of the Biotech/Large Molecule 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.
Key Responsibilities:
An 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 mAb network. Support further improvements in alignment where opportunities
Educational/Experience Requirements
Minimum Masters in a Biological Science or Engineering Discipline
Preferred 8-10 years industrial experience in a cGMP environment
Previous GMP Manufacturing experience and New Product Introduction Knowledge.
For further details, please contact Laurentina Kennedy at The RFT Group on +353 (0) 1-2302400 / laurentina@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie Follow us on: Linked-in