Process Specialist, Biologics
Our client, a major multinational biologics manufacturer based in Dublin, now seeks an experienced Process Specialist who will to support a new mammalian cell culture drug substance to the site.
The successful candidate will partner with donating site during technology transfer, will include tasks to plan, co-ordinate and participate in risk assessments, process trials, demo and PV batch manufacture. The role will then support subsequent commercial manufacture and related activities.
Responsibilities of Process Specialist, Biologics:
The Process Scientist will be a core member of the team to ensure that all equipment are designed & operated as intended and that the process is appropriately validated.
Provide process science and technology expertise to support facility, equipment and disposables design.
Author technology transfer documentation.
Participate in Gap Analyses and Process Risk Assessments.
Provide cell culture and purification process science & validation expertise for trouble-shooting and resolution of manufacturing process and technology issues during trials, demonstration and PV batch manufacture.
Develop site documentation for the new processes being transferred to site.
Develop process validation protocols and write up process validation summary reports and associated Regulatory filing summaries.
Assist in the raising and execution of process change controls.
Support Compliance Inspections and enquiries from Regulatory Agencies.
Requirements for Process Specialist, Biologics:
BSc Degree in either Bioprocess, Biotechnology, Chemistry or a related discipline.
Strong background in mammalian cell culture and/or purification process unit operations.
Knowledge and experience in biotechnology technology transfer, bioprocess equipment design and single use systems preferred.
Experienced in Introduction of new technology, including process analytical technology (PAT).
Experience of FDA and EU licensing and inspection.
Experience of process and cleaning validation execution.
Project Management experience.
Excellent communication and interpersonal skills and an ability to work independently.
Familiar with automated control systems.
Please phone Larry on +353 1-2302400 / email@example.com
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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