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Downstream MS&T

  1. Ireland, Dublin
County Dublin
  1. Contract
Competitive
  1. CAPEX Projects
36546
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Downstream MS&T - Dublin, Ireland - TBC

One of the top 10 best companies to work in Ireland is looking for Downstream MS&T for their large-scale new facility in Dublin. Is this you?

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Responsibilities include:
  • Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of one or more 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, ultra filtration 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.
  • To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
  • Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Cruiserath site.
  • Document and appropriately communicate aspects of work and learnings at internal and external fora (may include participation at scientific meetings)
  • Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site.
Key requirements include:
  • Minimum BSc or equivalent  experience in drug substance manufacturing technical support in the bio pharmaceutical industry.
  • 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 organisation, and in local group settings.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
  • Can effectively partner with and influence stakeholders without direct solid line authority.
  • Drives technical decisions balancing product quality and operational requirements.
If this role is of interest, please apply now!
 #LI-JS4

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