LSC have a great contract opportunity for a Technical Services Specialist – Upstream to join a Multinational Pharmaceutical Company based in Dublin.
If you have minimum 1-2 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o To provide technical process support in the area of media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors) to support the successful startup of the company’s BDS facility in Dublin.
o Working knowledge of typical cell culture unit operations, cause and effect, collation of data and trends. Performing process monitoring/trending.
o To author and review process supporting documentation, 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.
o To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
o Partner with Operations to support protocol completion, execution and sample reconciliation
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage
o Technical and operational knowledge of multiple unit operations in upstream processing, including media preparation, mammalian cell culture, centrifugation & depth filtration.
o Understanding of technology transfer, scale-up process and cleaning verification/validation is advantageous.
o Understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
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 Ruth Holland at LSC on 021-4777329 if you have anymore questions about this Technical Service Specialist – Upstream opportunity!