LSC have a great contract opportunity for a Tech Transfer Manufacturing Technology (MT) Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the MPCC Cruiserath.
- Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
- Upstream (Cell culture focus) including media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, single use systems, seed and production bioreactors and harvest centrifugation/clarification).
- Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
- Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
- To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum BSc or equivalent with at least 3 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
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!
Apply via this advert or contact Adam Murphy on +353214718214 if you have any more questions about this role!
