Job Description
Our client is a highly profitable fast growing multinational biologics manufacturer based in Dublin, now seeks a Senior Cell Culture Specialist for Upstream Bioprocess Management activities for their Drug Substance products - providing technical support on registration and post-registration stages of the product lifecycle.
The successful candidate will manage investigation and resolution of upstream process deviations, root cause investigation, CAPAs, troubleshooting, process improvement, cost reduction, capacity expansion, technical transfer and validation activities. This role will also cover some downstream bioprocessing activities.
Additionally, this position will provide technical support for quality systems governing GMP manufacturing, regulatory submissions, and facility inspections. This position will serve as technical review/approval for manufacturing related documents.
The ideal candidate will have proven experience in supporting process technology transfers and the preparation of CMC documentation for regulatory filings.
This hire will act as a point of contact for all technical services groups related to all CMC matters internally and for CMO?s and driving CMO partnership.
Requirements for Senior Cell Culture Specialist / Upstream BioProcess Manager:
Bachelor Degree in Sciences or Engineering or technical discipline. Master?s Degree or above in technical / scientific education, pharma desired.
6+ years? industry experience hands-on experience of all aspects of commercial manufacturing processes.
Subject Matter Expert in all CMC drug substance activities, process development, process management and trouble-shooting, process robustness improvement, etc.
Six Sigma and Statistical knowledge is highly desirable.
Successful track record of change management projects and processes.
Knowledge and understanding of Regulatory requirements (cGMP, filing, EHS).
Confident management of internal and external stakeholder relationships.
Strong communication and negotiation skills are required for this position.
Proven ability to translate technical issues into business impact and relevant solutions.
The position will require varying levels of travel, circa once per month.
Please contact Larry on +353 (0) 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. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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