LSC have a great contract opportunity for a Specialist Technical Specialist to join a biopharmaceutical company based in Dublin. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have minimum of 8 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations or downstream unit operations, process/facility fit, New Product Introduction Technology Transfer and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide process information and analysis to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, in a multi-product BDS facility.
o Participate in Tech Transfer Receiving Unit activities, and provide technical guidance to team members in large scale cell culture/downstream purification processes, and provide SME support for the area on key audit topics.
o Provide scientific and technical input to facilitate decision making related to Tech Transfer.
o Develop/provide deep technical knowledge and understanding in cell culture processes; vial thaw, seed expansion, seed reactors and large scale production bioreactors, including centrifugation and depth filtration steps, or downstream purification processes; large scale column chromatography steps, ultrafiltration/diafiltration steps, pH adjustment, depth/nanofiltration steps, and final fill.
o Undertake technical risk assessments to support raw material assessment for NPI.
o Identify technical issues, and guide resolution of same.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
o In-depth technical and operational knowledge of multiple unit operations in cell culture processing, centrifugation, depth filtration. Understanding of cause and effect of cell culture metabolism, or downstream processing with chromatography, UFDF, viral filtration and sub-micron filtration, pH adjustment and final fill.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Aaron Kingston at LSC on 021-4777329 if you have anymore questions about this Specialist Technical Services opportunity!