Job Description
My client a leading Pharmaceutical company now require a Operations Team Lead to join their rapidly expanding team.
The Operations Team Lead will act as the operations team lead in a new regenerative medicine manufacturing facility been built.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Operations Team Lead
Lead the operations team of plant technologists in biologics manufacturing
Delegate tasks and communicate priorities to plant technologists
Support the development of the new operations team structure.
Understand manufacturing requirements associated with cell culture manufacturing and communicate them to the project and operations team.
Support the site start-up phase from manufacturing side with regard to process simulation (media fills), pilot runs and process validation.
Liaise with QC, QA, and Logistics to safeguard the start-up schedule of the site
Provide leadership to manufacturing teams in order to ensure that the manufacturing can be operated to optimum efficiency and in compliance with Quality standards. This includes (but is not limited to) production finite planning and production performance monitoring.
Support operations team with achieving overall operational readiness schedule adherence.
Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
Safeguard the timely and GMP compliant production of registration samples & clinical trial material
Complete required documentation relating to development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) BMRs, SOPs, Logbooks and EOPs.
Safeguard audit readiness incl. continuous compliance with all applicable regulations in area of responsibility.
Requirements of Operations Team Lead
At least 5 years' experience in aseptic manufacturing environment in the pharmaceutical/biopharmaceutical industry, preferably with experience in the leadership of teams. Experience of aseptic GMP manufacturing and filling is preferred.
Manufacturing experience in biopharmaceutical operations involving cell cultures or Regenerative Medicines and Vaporized Hydrogen Peroxide decontamination an advantage.
Experience in operational excellence Lean/Six Sigma, Green Belt Certification is an advantage
Excellent planning, scheduling and prioritization ability
Excellent documentation skills and attention to detail.
Ability to work under pressure & managing conflicting tasks at the same time.
Experience in electronic quality management and document systems (EQMS, EDMS), manufacturing execution systems (MES) and SAP an advantage
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below