LSC have a great contract opportunity for a Technical Services 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.
o Provide SME knowledge and understanding in BDS manufacturing processes (upstream/downstream); cause and effect, scale up principles, QRM, and process validation strategies.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
o An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable
o Previous experience of a technology transfer participated is advantageous.
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 Technical Services Specialist opportunity!