LSC have a great contract opportunity for a Senior Technical Services Specialist to join a biopharmaceutical company based in Westmeath. 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 3 to 6 years experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide significant technical expertise to support all aspects of the mammalian bulk drug substance cell culture and purification manufacturing at the biologics Facility
o Process SME to support commissioning, automation and manufacturing operation teams.
o Support technology transfers of new products into the company Facility
o Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
o SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
o To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
o To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
o Experienced in relevant unit operations including vial thaw and scale up, seed train and production bioreactors, harvest, chromatography, UF/DF, viral filtration and inactivation, final formulation and media and buffer preparations.
o Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
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 Senior Technical Services Specialist opportunity!