Microbiology Lab Lead

Team Horizon is seeking a Microbiology Lab Lead  for our client based in Sligo. This person will be responsible for leading a team of experienced microbiology professionals responsible for facility and utility Environmental Monitoring testing as well as in process and release testing for finished products.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Provide an effective testing service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met.


• Ensure that the Laboratory meets its customer quality, service, regulatory and financial goals through the effective management of the Micro Laboratory function.


• Manage the Micro Laboratory Team. This includes all laboratory operations from facility, utility qualification sampling and testing incoming materials, in-process sampling and testing, finished
  product sampling and testing, stability testing, documenting test results and generation of COA’s. It also covers specific areas such as equipment validation and lab project activities.


• Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.


• Ensure that all test equipment used to disposition material is maintained and calibrated correctly.


• Approval of micro laboratory documents.


• Ensure all sampling, inspection and testing is completed in a timely manner.


• Liaise with Warehouse/Planning/Manufacturing and Production Teams regarding sampling and testing schedules/priorities.


• Actively participate in internal and external audits and follow up on audit findings.


• Assist in the resolution of specific manufacturing quality problems as required.


• Responsible for the timely execution and completion of all phases of raw materials, in-process testing and finished products.


• Assist in the transfer of test methods for new products.


• Carry out specific tasks and projects as delegated by site management. Supervise any personnel assigned to assist in completion of the task.


• Ensure management is kept informed of system failures on a regular basis to ensure corrective/preventive action is taken where required.


• Ensure adequate test results are maintained for all manufactured lots.


• Manage Lab team towards achieving day to day and long-term goals and provide the training/support necessary to ensure this.


• Co-ordinate plant stability program for products as required.


• Adheres to and supports all EHS & E standards, procedures and policies

What you need to apply:

• M.Sc. / B.Sc. in Microbiology or related discipline


• Minimum 5 years experience in the biopharmaceutical industry in a laboratory role.


• Good knowledge of QA/QC operations with detailed knowledge of specifications, test methods, lab testing equipment.


•  Supervisory experience of 2-3 years.