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Contract Recruitment for GxP Regulated Industries
We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dunboyne. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
* Collaborate with stakeholders to identify and execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification)
* Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes
* Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
* Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents
* Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual
* Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, to progress the team forward to “one-click” tech transfer
* Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
* Ensure the highest Quality, Compliance and Safety standards.
Education & Experience
* Minimum of 5 years of work experience in the pharmaceutical or biotech industry
* Bachelor’s degree in: Biotechnology, Engineering, Chemistry, or related field.
* Experience with project management with cross-functional team members.
* Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing
* Competent in analyzing complex situations and showing practical problem-solving capabilities
* Experience with quality management and compliance systems.
* Understanding of the general principles of New Product Introduction (Tech Transfer)
* Familiarity with the use of Automation systems in a manufacturing Process.
* Competency in the use of automated/digital systems such as DeltaV, MES, eVal
* Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
* Familiarity with risk assessment processes
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Engineering and Quality Assurance
Industries
* Biotechnology Research and Pharmaceutical Manufacturing
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