Job Description
Our client, a multinational biotech company, now seek a highly motivated Bioprocessing Manufacturing Manager who will lead and manage all production operations, including aseptic manufacturing, filling and packaging and production related warehousing & logistics within their bioprocessing plant.
The successful candidate will lead Operations and Technology Transfers of NPIs at their manufacturing site, while also supporting operational readiness for aseptic manufacturing and filling at their facility.
The ideal candidate with be a SME for aseptic processing in compliance with GMP. Proven experience in representing manufacturing in internal, global and regulatory audits is highly desirable.
Responsibilities of Bioprocessing Manufacturing Manager:
Liaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
Understand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.
Lead the process validation.
Provide direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency and in compliance with Quality standards.
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.
Complete required documentation relating to technology transfer, development and manufacturing activities in an accurate and timely manner.
Lead and manage production operations (aseptic manufacturing, filling and packaging) and production related warehousing & logistics within the bioprocessing plant.
Driving compliance and schedule adherence to ensure the operational plan is achieved, including close out of all documentation.
Maintain and develop quality standards to cGMP guidelines; operations lead in regulatory and customer audits (e.g. HPRA audits, Sterility Assurance, Environmental Health & Safety).
Take ownership of environmental performance in the manufacturing area and work continuously to improve control strategies and employee engagement in this area.
Lead and support investigations in manufacturing and technical deviations.
Facilitate training and development of all production, warehousing personnel of the Bioprocessing Plant, to cGMP standards.
Ensure that appropriate validations are in place in the area of responsibility (e.g. process validation, cleaning validation, aseptic validation)
Requirements for Bioprocessing Manufacturing Manager:
Bachelors Degree in Science, Engineering or related Lifescience discipline is preferred.
8+ years’ experience in pharmaceutical manufacturing including technology transfer, ideally aseptic manufacturing operations with at least 3 years of experience at leadership level.
In-depth knowledge of aseptic manufacturing operations, including EU GMP regulations specific to aseptic manufacturing.
Manufacturing experience in biopharmaceutical operations involving cell cultures or recombinant medicines is preferred.
Excellent project management skills. Project Management Professional (PMP) is a plus
Experience in electronic quality management and document systems (EQMS, EDMS), manufacturing execution systems (MES) and SAP an advantage
Travel requirements: Up to 15% during project phase.
Please phone Larry on +353 1-2302400 / larry@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
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