LSC have a great contract opportunity for a Technical Services Specialist – Downstream to join a Multinational Pharmaceutical Company based in Dublin.
If you have minimum 5 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 The Purification (Downstream) Technical Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) as part of the Technical Services Team at the company’s facility in Blanchardstown, Dublin.
o The Technical Specialist will provide protein purification processing expertise to support the facility design, start-up and routine commercial manufacturing for chromatography, UFDF/TFF filtration, Viral filtration technologies and bulk fill unit operations respectively.
o The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification (PPQ).
o The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for purification unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.
o To provide process expertise in the area of buffer preparation, large scale protein purification drug substance manufacturing process (column chromatography, VI, UFDF/TFF, Viral filtration and bulk fill) to support the successful startup of the company’s BDS facility in Dublin.
o Working knowledge of typical chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles.
o To author and review process transfer documentation, gap assessments, technical protocols and reports, including process validation documentation & strategy documents.
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 downstream protein purification processing (chromatography, filtration, TFF).
o In-depth technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, industrial scale protein purification, TFF filtration, final fill, nano and process filtration.
o Strong understanding of technology transfer, scale-up process and cleaning validation.
o Comprehensive understanding of cGMP requirements for clinical and 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 – Downstream opportunity!