My client a leading Pharmaceutical company now require a Manufacturing Supervisor – Biologics to join their expanding team.
The Manufacturing Supervisor – Biologics will act as the operations team lead in a new regenerative medicine manufacturing facility, they will support the development of the site operational structure particularly with regards to regenerative medicines manufacturing. They will report directly to the Manufacturing Manager.
This is a permanent position based in Dublin and comes with a strong salary and benefits package.
Manufacturing Supervisor – Biologics
- 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
- 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.
- Lead and manage production operations (aseptic manufacturing, filling and packaging) and production related warehousing & logistics within the bioprocessing plant.
- Provide leadership to manufacturing teams of plant technologists 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 fine planning, production order management and production performance monitoring.
- Manage escalation, decision making and communication within production teams.
- Foster compliance and schedule adherence to ensure the operational plan is achieved, including close out of all documentation.
- Support and lead activities to improve environmental performance in own area of responsibility and work continuously to ensure the strongest environmental performance possible by proactively and constantly improving control strategies and employee engagement in this area.
- Lead and support investigations in manufacturing and technical deviations (RCAs).
- Support and facilitate training and development of plant technologists, ensuring they have the skills and knowledge to carry out their duties efficiently and safely and according to cGMP standards.
- Execute, lead and participate in product and process risk assessments and investigations.
Requirements of Manufacturing Supervisor – Biologics
- 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 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